Gavi to make 500,000 doses of Ebola vaccine available for outbreak response

Syringe drawing from a vial labelled 'Ebola Vaccine'Gavi, the Vaccine Alliance, has funded an emergency stockpile of 500,000 doses of Ebola vaccine, which will be available to all countries for outbreak response following procurement. Gavi-eligible low- and lower middle-income countries will be able to access the stockpile free of charge and will receive support for operational costs to conduct outbreak response immunisation activities.

According to the alliance, it supported the establishment of the Ebola vaccine stockpile prior to the COVID-19 pandemic to strengthen the world’s defences against the threat of devastating infectious disease outbreaks. Through the Advance Purchase Commitment (APC), its innovative financing mechanism, Gavi created strong incentives for manufacturers to accelerate their Ebola vaccine developments. Essentially the alliance committed to procure doses once a safe and effective vaccine was prequalified by the World Health Organization (WHO).

This APC also ensured that doses of the investigational vaccine could be deployed on a compassionate use basis during outbreaks, prior to the vaccine being licensed. This has so far helped end the outbreak in North Kivu and Ituri provinces, with over 300,000 people vaccinated against the disease in the Democratic Republic of Congo and neighbouring countries.

“This is a true success story for the Vaccine Alliance that illustrates the strength of our public-private partnership. The accelerated development of the Ebola vaccine was possible thanks to a first-of-its-kind agreement between Gavi and the vaccine manufacturer, which set a precedent for fast-tracking development and production of vaccines against COVID-19,” said Gavi Chief Executive Officer, Dr Seth Berkley. “By creating a stockpile of 500,000 doses of the Ebola vaccine, available to all countries, we can help prevent loss of life and swiftly end Ebola outbreaks in the future.”

The stockpile will include licensed doses of the single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live) manufactured by MSD, which has received approval from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), in addition to prequalification from WHO. The first deliveries of doses into the stockpile are being funded through a $20 million contribution from the United States Agency for International Development (USAID). Decisions on vaccine allocations from the stockpile will be made by an International Coordinating Group (ICG) comprising WHO, UNICEF, International Federation of Red Cross and Red Crescent Societies (IFRC) and Médecins Sans Frontières (MSF).

“The stockpile of thousands of Ebola vaccines is a ground-breaking development,” said UNICEF Executive Director Henrietta Fore. “It is testimony to the unrelenting and unprecedented efforts of this global partnership to fight Ebola outbreaks – and it provides an opportunity to learn from this success as we prepare for the global rollout of COVID-19 vaccines.”

There are currently several other candidate vaccines for Ebola virus disease (EVD) at different phases of development that may be eligible for eventual inclusion into the stockpile once they have received WHO prequalification.

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Fire at Serum Institute of India, production site of COVID-19 vaccine

COVID-19 vaccineAccording to reports, a fire at the Serum Institute of India (SII) has killed five people. However, government officials have said that this would not affect production of the Oxford-AstraZeneca COVID-19 vaccine that is being made at the facility. 

As reported by Reuters, black smoke could be seen coming out of the multi-storey building in SII’s headquarter complex in the city of Pune in Maharashtra state.

“We have learnt that there has unfortunately been some loss of life at the incident. We are deeply saddened and offer our deepest condolences to the family members of the departed,” said SII Chief Executive Adar Poonawalla on Twitter.

The Maharashtra state government said the fire could have been caused by an electrical fault during construction work, the report says. While five people died, four others were evacuated. 

“I would like to reassure all governments & the public that there would be no loss of COVISHIELD production due to multiple production buildings that I had kept in reserve to deal with such contingencies,” Poonawalla said. 

SII has licensed the shot developed by Oxford University and AstraZeneca and was planning to start stockpiling up to 50 million doses a month of a vaccine candidate developed by Novavax from April. The facility will make COVID-19 vaccines for many low- and middle-income countries. At other facilities on the complex, SII is purportedly producing approximately 50 million doses of the AstraZeneca vaccine a month, with plans to increase that to as much as 100 million doses.

According to the report, Poonawalla said the fire would mean delays in launching new products and revenue losses of more than $137 million. He also said that equipment worth millions of dollars was damaged. 

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Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC

Shots:

  • The approval is based on P-II Brigatinib-2001 (J-ALTA) assessing Alunbrig in 72 Japanese patients with ALK+ NSCLC and P-III AP26113-13-301 (ALTA-1L) study assessing Alunbrig (180mg, qd with seven-day lead-in at 90mg, qd) vs crizotinib (250mg, bid) in 275 patients with ALK+ advanced NSCLC prior not treated with an ALK inhibitor
  • The therapy showed effectiveness in patients undergoing 1L & 2L treatment for ALK+ NSCLC including efficacy in patients with brain metastases.
  • Alunbrig is a potent and selective next-generation TKI designed to target ALK molecular alterations and is approved in 30+ countries including the US & EU

Click here ­to­ read full press release/ article | Ref: Takeda | Image: The Boston Globe

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New York seeks to buy vaccines directly from Pfizer

New York seeks to buy vaccines directly from Pfizer

cbaker_admin
Fri, 01/22/2021 – 07:30

Gov. Andrew Cuomo of New York on Monday requested Pfizer to sell its COVID-19 vaccine directly to the state. In a letter to Pfizer CEO and Chairman Albert Bourla, Cuomo said he was calling on the company directly after HHS Secretary Alex Azar failed to adhere to a commitment to increase doses to New York. Cuomo said the state received 250,000 doses this week—50,000 fewer than last week—even after CDC broadened the categories of populations who were eligible to receive a dose, including people aged 65 years and older. That makes some 7 million New Yorkers now eligible, and it would take as long as 7 months to vaccinate them all at the current supply, according to Cuomo. He also noted in his letter that he believed Pfizer was not restricted by commitments that Moderna made as part of President Trump’s Operation Warp Speed. Pfizer spokeswoman Jerica Pitts said the company will consider more extensive cooperation, but federal approval would be required for any direct sales to states. Meanwhile, an HHS spokesperson said Monday that New York has only administered about one-half of the doses it has received from the federal government.

Biden signs executive orders on face-mask mandate, Keystone Pipeline, Paris Accord

Biden signs executive orders on face-mask mandate, Keystone Pipeline, Paris Accord

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Fri, 01/22/2021 – 07:30

In his first few hours in office, President Joe Biden signed 15 executive orders and two executive actions covering a wide range of policies, including implementing a national mask mandate on federal property. The 100-day mandate applies to all federal property and on airlines, trains and transit systems traveling between states. The orders also include ceasing the United States’ withdrawal from the World Health Organization and rejoining the Paris climate accord. “These are two early steps to advance the president’s ambition to re-engage in the world,” said incoming national-security adviser Jake Sullivan. Another executive order establishes an office of White House COVID-19 response that will work with federal agencies and report directly to the president. Goals of the new office — which will be led by Jeffrey Zients, Biden’s coronavirus czar — include obtaining more protective equipment for workers, increasing testing and vaccinations, and reopening schools.

HHS awards funds to expand immunization information sharing collaboration

HHS awards funds to expand immunization information sharing collaboration

cbaker_admin
Fri, 01/22/2021 – 07:30

The Office of the National Coordinator for Health Information Technology, part of HHS, announced plans to grant nearly $20 million in funding from the 2020 CARES Act to help combat the COVID-19 crisis. Specifically, the federal monies will go toward efforts to help enhance the sharing of health information related to vaccinations. In turn, data sharing improvements will better efforts to track the vaccination process; help public health agencies identify patients still waiting on their second dose; flag high-risk Americans who have yet to receive a first dose; and create an opportunity to collect high-quality vaccination outcomes. The nation’s 100 health information exchanges (HIEs) and 63 immunization information systems are critical to the campaign. “In collaboration with HIEs, the ability to individually correlate every patient who has received the vaccine with all of their clinical data both pre- and post-vaccination could offer more detailed insight into any adverse events and long-term health outcomes than is currently possible,” HHS noted in a press release.

APhA: Biden’s COVID plan is a strong start to rescue the country from the pandemic

APhA: Biden’s COVID plan is a strong start to rescue the country from the pandemic

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Fri, 01/22/2021 – 07:30

In a statement, Scott J. Knoer, executive vice president and CEO of APhA, praised (now) President Joe Biden’s plan to address the COVID-19 public health emergency, calling it “a strong start to rescue the country from the pandemic.” The plan “not only allocates billions of dollars to launch a sweeping national plan for vaccination and testing, it also invests in public health workers for outreach and contact tracing, addresses health disparities, protects residents of long term care facilities and workers in essential industries, and proposes billions for the administration of the vaccines,” he said. “The incoming administration has stated that this is a race against time — and we agree. It is essential that this plan builds on utilizing the army of ready, willing and able pharmacists, pharmacy technicians, and pharmacy interns in all practice settings to accelerate the vaccination of all Americans,” Knoer said. “Approximately 400,000 pharmacy personnel have been trained for precisely this moment — and now is the time to mobilize them.”

WV state officials say locally owned pharmacies key in vaccination rollout

WV state officials say locally owned pharmacies key in vaccination rollout

cbaker_admin
Fri, 01/22/2021 – 07:30

West Virginia has the highest per-capita COVID-19 vaccination rate in the country, due in no small measure to the involvement of community pharmacies. The rollout was planned by the state’s Joint Interagency Task Force (JIATF), with representation from various agencies and organizations. Because 45% of West Virginia pharmacies are locally owned, the decision to use them for vaccine administration in addition to the two federal partners—CVS Health and Walgreens—was key. Krista Capehart, who represents JIATF pharmacy members, says the inclusion of home-grown locations has been instrumental in reaching residents in rural areas especially. “We invited all pharmacies because it’s truly about that pharmacist relationship whether they’re working in an independent or chain,” she explains. “People prefer to go to their pharmacist so we invited all of our pharmacies.” The decision also leveraged the existing relationships between community pharmacies and local assisted-living facilities to streamline the process.

Pennsylvania partners with Rite Aid to vaccinate priority populations in congregate and long-term care settings

Pennsylvania partners with Rite Aid to vaccinate priority populations in congregate and long-term care settings

cbaker_admin
Fri, 01/22/2021 – 07:30

Pennsylvania’s departments of Human Services (DHS) and Health (DOH) announced a partnership on Tuesday between the state and Rite Aid to administer COVID-19 vaccinations to staff and residents of certain long-term care facilities and congregate care settings licensed by DHS. These facilities are prioritized for vaccination in Phase 1A of Pennsylvania’s Interim Vaccination Plan, but most are not included in the federal Pharmacy Partnership program. The new partnership with Rite Aid begins on January 27, and calls for establishing clinics where residents and staff of DHS-licensed facilities can go to obtain vaccine doses at a scheduled time. If individuals served are not able to travel to a clinic site, vaccinations will take place on-site at the facilities. Vaccinations will not take place at Rite Aid pharmacies as part of the new partnership for DHS-licensed facilities. Pennsylvania is also participating in the federal Pharmacy Partnership program to coordinate vaccination for skilled nursing facilities, which are licensed by DOH, as well as personal care homes, assisted-living facilities, and intermediate care facilities for people with disabilities licensed by DHS. Other long-term and congregate care settings included in Phase 1A of Pennsylvania’s Interim Vaccination Plan—group homes for people with disabilities, residential treatment facilities and long-term structured residences for adults with behavioral health needs, and private psychiatric hospitals—are not included in the federal partnership but are still in Phase 1A due to the risk of COVID-19 outbreaks in congregate settings.

Moderna on track to make 100 million vaccine doses by end of March, CEO says

Moderna on track to make 100 million vaccine doses by end of March, CEO says

cbaker_admin
Fri, 01/22/2021 – 07:30

Moderna reports it is on track to produce enough doses of its new COVID-19 vaccine to help meet President Joe Biden’s goal of administering 100 million vaccine doses in the first 100 days after he takes office on Wednesday. Moderna CEO Stéphane Bancel said Moderna plans to deliver 100 million doses of its vaccine by the end of March, with additional doses to follow. Bancel cautioned there are some issues beyond his company’s control, such as last-mile distribution hiccups and timely delivery of the raw materials used to produce the vaccine. Bancel said Moderna is monitoring the appearance of mutations in the new coronavirus, noting the company’s vaccine should still be effective if mutations are limited. While Moderna might have to develop a new vaccine if mutations proliferate, Bancel noted a new vaccine would share many features with the original one that proved effective and relatively safe in testing. The company also is monitoring reports of allergic reactions among some California residents who received its vaccine. The drugmaker said Tuesday that about 1.3 million doses were produced in the lot under scrutiny, and just under a million of those were distributed to about 1,700 vaccination sites in 37 states. CDC said earlier this month that while the rate of severe allergic reactions from COVID-19 vaccines is higher than for seasonal influenza vaccines, severe reactions were rare, and federal health officials encouraged their use.

USPSTF: Interventions for tobacco smoking cessation in adults, including pregnant persons

USPSTF: Interventions for tobacco smoking cessation in adults, including pregnant persons

cbaker_admin
Fri, 01/22/2021 – 07:30

The US Preventive Services Task Force (USPSTF) reviewed the risk/benefit profiles of primary care interventions on smoking cessation among adults. The review, intended to inform an update to the panel’s 2015 recommendation, identified substantial net benefit in behavioral stop-smoking interventions for both pregnant and non-pregnant adults as well as for perinatal outcomes. FDA-approved pharmacotherapy interventions also have a clear benefit for adults who are not pregnant; however, the same cannot be said for expectant mothers, due to a dearth of trial data. USPSTF additionally found that evidence on the use of e-cigarettes as a strategy for smoking cessation is also inadequate, for both pregnant and non-pregnant adults. Based on these findings, the USPSTF “recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide both behavioral interventions and FDA-approved pharmacotherapy for cessation to nonpregnant adults who use tobacco.” Its second recommendation calls for clinicians to “ask all pregnant persons about tobacco use, advise them to stop using tobacco, and provide behavioral interventions for cessation to pregnant persons who use tobacco.” While the updated USPSTF recommendation statement reflects the most recent research and language related to tobacco cessation, the recommendations in terms of what services primary care doctors should offer remain the same as in the 2015 statement.

Home and online management and evaluation of BP using a digital intervention in poorly controlled hypertension

Home and online management and evaluation of BP using a digital intervention in poorly controlled hypertension

cbaker_admin
Fri, 01/22/2021 – 07:30

In the United Kingdom, researchers evaluated the potential value of a digital intervention for hypertension control in the primary care setting. The HOME BP study included 622 adults with high blood pressure that was poorly managed. Per unblinded randomization, 305 patients were instructed to self-monitor their blood pressure plus use the digital intervention. The cohort received reminders, individualized but predetermined drug changes based on blood pressure readings, lifestyle recommendations, and behavioral support. The remaining 317 trial enrollees underwent standard care, attending appointments and adjusting medications as their general practitioner deemed necessary. The study period was for 1 year, at which time investigators measured the difference in systolic blood pressure compared with baseline levels. Mean blood pressure dropped to 138.4/80.2 mm Hg from 151.7/86.4 in the intervention group and to 141.8/79.8 mm Hg from 151.6/85.3 in the control group. The findings demonstrate the HOME BP digital intervention as an effective and cost-effective strategy for improving systolic blood pressure over the course of 12 months.

Effect of endovascular treatment with vs. without I.V. alteplase on functional independence after acute ischemic stroke

Effect of endovascular treatment with vs. without I.V. alteplase on functional independence after acute ischemic stroke

cbaker_admin
Fri, 01/22/2021 – 07:30

Research out of China asked whether endovascular treatment by itself would be just as effective as endovascular treatment plus I.V. alteplase in achieving 90-day functional independence in certain stroke patients. The study enrolled 234 adults with acute ischemic stroke secondary to large vessel occlusion, all of whom qualified for I.V. thrombolysis. Approximately one-half of the participants were randomly assigned to endovascular thrombectomy only, with the other one-half allocated to I.V. alteplase in conjunction with endovascular thrombectomy. The primary outcome, evaluated at 90 days, was the share of patients in each treatment arm who achieved functional independence. Followup revealed that 54.3% of participants in the single-therapy group met that endpoint, vs. 46.6% of participants in the combined-therapy group. The -10% threshold to demonstrate noninferiority was satisfied, suggesting that endovascular thrombectomy alone promotes functional independence in stroke patients as well as the standard approach of endovascular treatment paired with I.V. alteplase.

Fauci tells the WHO that the U.S. stands ready to work with it

Fauci tells the WHO that the U.S. stands ready to work with it

cbaker_admin
Fri, 01/22/2021 – 07:30

One year after the United States documented its first COVID-19 case, the country’s top infectious disease expert said America would resume cooperation with the World Health Organization (WHO) to combat the pandemic. Former president Donald Trump announced last May that the United States would withdraw from the global body over its handling of the emerging crisis, but President Joe Biden reversed the move on his first day in office. “The United States stands ready to work in partnership and solidarity to support the international COVID-19 response, mitigate its impact on the world, strengthen our institutions, advance epidemic preparedness for the future, and improve the health and well-being of all people throughout the world,” said Anthony S. Fauci, MD, via video link during a meeting of the WHO’s executive board on Thursday. That commitment, he continued, entails the United States satisfying its financial obligations to WHO and joining the organization’s COVAX initiative to distribute coronavirus vaccines to poorer nations, among other steps.

Biden issuing pandemic plan that aims to expand access to testing and vaccines, reopen schools

Biden issuing pandemic plan that aims to expand access to testing and vaccines, reopen schools

cbaker_admin
Fri, 01/22/2021 – 07:30

On January 21, his first full day in office, President Joe Biden will unveil his administration’s playbook for ending the COVID-19 crisis. The 21-page national strategy houses seven broad goals, starting with regaining the public trust through regular briefings with CDC and other government scientists and public sharing of data. Among other objectives, the plan also aims to broaden testing and vaccination; safely reopen schools and travel; and help states financially, in part by convincing Congress to cover the cost for states to vaccinate low-income Medicaid beneficiaries. Biden also signed three executive orders on Inauguration Day that, respectively, require masks and social distancing at all federal properties, pull back the Trump administration’s withdrawal from the World Health Organization, and bring back a White House division on global health security and biodefense that was dismantled a few years ago. In tandem with the new pandemic plan expected today, the directives present a dramatically different approach to the Trump administration’s response to the public health crisis, which encouraged states to develop individual pandemic response plans.

ViiV/J&J’s long-acting HIV regimen finally approved in US

The FDA has approved Cabenuva, a long-acting HIV treatment from ViiV and Johnson & Johnson that keeps the virus at bay with a monthly injection instead of daily pill regimen.

It follows a surprise rejection at the end of 2019, due to the information in the dossier related to chemistry, manufacturing and controls (CMC).

The clinical data supplied by ViiV was enough to support approval, however, and the FDA has finally given the go-ahead for Cabenuva.

Cabenuva is based on ViiV’s long-acting integrase inhibitor cabotegravir and the non-nucleoside reverse transcriptase inhibitor (RTI) Edurant (rilpivirine) developed by J&J’s Janssen pharma unit.

ViiV, which is a joint venture with GlaxoSmithKline as a majority shareholder, with Pfizer and Shionogi holding minority interests, noted that this is the first treatment to offer this less demanding treatment regimen.

The injection is delivered in a clinic and aside from clinical data supporting its safety and efficacy, ViiV said nine out of ten patients preferred the dosing regimen to their previous daily oral therapy in the studies used for approval.

This was based on a survey filled in alongside one of the trials used for approval, where 532 patients completed a single-item question at Week 48.

Results showed 88% preferred Cabenuva compared with 2% who preferred their previous daily oral HIV treatment.

The results were descriptive in nature and are not intended to imply clinical significance, ViiV noted in a statement, adding that only 59 patients chose not to answer the questionnaire.

The approval of Cabenuva is based on the pivotal phase III ATLAS studies that included more than 1,100 patients from 16 countries.

Before treatment with Cabenuva, oral dosing of cabotegravir and rilpivirine (lead-in) was administered for around one month to assess the tolerability of each therapy.

In these studies, Cabenuva was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly in the buttocks once a month throughout the 48-week study period.

In both studies, the most common adverse reactions 2% or more of clinical trial participants receiving Cabenuva were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.

Serious adverse events occurred in 4% (24/591) of patients taking Cabenuva, and 3% (17/591) of adverse events led to withdrawal.

 

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Assessing physician practices and expectations in the post-COVID era

The ongoing COVID-19 pandemic has affected the routines of many practicing physicians, including an impact on their prescribing decisions. New research from CRA shows that for many physician practices, prescribing has shifted based on route of administration. These changes, initially presumed to be temporary, may continue beyond the pandemic.

As several COVID-19 vaccine candidates progress to patients and with more than 150 other vaccines in clinical development, global communities look forward to returning to “normal life,” but it is also increasingly likely that what we return to will be a “new normal”.

For many practicing physicians, changes presumed to be temporary just a few months ago may in fact become part of more permanent changes to their practice structure. As the COVID-19 pandemic continues, personal protective equipment (PPE) requirements, social distancing, increased telehealth and fewer in-person doctor visits have become common.

Many physicians are also now reporting affordability issues among their patients. In this article, we focus in particular on how COVID-19 may be changing prescribing decisions using market research and claims data.

Together with research partner Dynata, Charles River Associates (CRA) conducted a recent survey of 140 physicians to better understand their perceptions of the pandemic’s effects on their daily practice, including current and potential future changes.

The survey focused on oncologists and neurologists, two specialties that regularly see immunocompromised patients receiving long-term treatment, and also surveyed pulmonologists and urologists to gauge the wider impact on prescribing habits. The findings (both self-reported by physicians and observed in claims) suggest that the pandemic is affecting the therapies that patients receive, as healthcare providers (HCPs) look to reduce the risk of their patients contracting COVID-19.

Analysis of prescribing changes

Based on the survey results, the majority of HCPs (61%), especially oncologists, report changing their prescribing decisions in some way as a result of COVID-19 (see Figure 1). The proportion of physicians who reported changing prescribing decisions varied, ranging from 77% for oncologists to 46% for urologists (pulmonologists and neurologists reported changing their prescribing decisions 54% and 65% of the time, respectively). Ways in which physicians changed their prescribing decisions include:

  • Shifting prescribing toward therapies with less frequent dosing (reported most often by oncologists [40%] followed by neurologists [26%])
  • Moving toward more established therapies (reported most often by neurologists [37%])
  • Moving toward therapies with fewer side effects (reported most often by pulmonologists [26%])
  • Most commonly, moving toward therapies that require less in-person contact, such as subcutaneous or oral medicines versus intravenous medicines (reported most often by oncologists [43%] and neurologists [37%])

Figure 1. Changes in Prescribing by Specialty

Source: CRA market research (conducted June 2020)

Each of these changes may offer potential benefits for both HCPs and patients. For example, prescribing more established therapies or therapies with more robust efficacy and safety data may make it easier for HCPs to titrate dosing or manage adverse events. Shifting prescribing toward therapies that require less frequent dosing and less in-person contact (such as moving from an intravenous therapy administered in an infusion centre to a subcutaneous therapy that can be administered conveniently at home) has clear potential benefits as a result of reducing interaction that may spread COVID-19.

There are also special considerations for immunocompromised patients including those with cancer or autoimmune disorders such as multiple sclerosis (MS) who are shown to be at increased risk of complications and death from COVID-19. Given their susceptibility to contracting COVID-19 and its associated complications, oncologists and neurologists may be especially motivated to look for opportunities to reduce the risk to immunocompromised patients, including reducing the amount of in-person contact and hands-on management. Switching to therapeutic options that involve less in-person contact may also be more amenable for patients who feel uncomfortable or have difficulty traveling to an infusion centre safely during the pandemic. Fewer patients coming in and out of an infusion centre may help infusion nurses and other staff to also reduce their potential exposure to COVID-19.

Overview of patient claims data

To further explore the impact of COVID-19 on prescribing decisions among neurologists and oncologists specifically, including the proportion of infused therapies prescribed, CRA worked with data from Compile to analyse claims data from patients with MS and HER2+ breast cancer (see Figure 2). These data cover about 30% of US pharmacy claims and about 50% of US medical claims for these conditions.

More than 100,000 MS patients were included in the data set, defined as patients with two or more MS-related medical claims or one or more MS-related medical claims plus a related pharmacy claim identified between January 2019 and June 2020. Focusing on the subset of MS patients shown to have received treatment from neurologists during this time period, infusion therapies (specifically Lemtrada, Ocrevus, and Tysabri) showed a decline of 19% in terms of the total number of claims from February to June 2020.

Our team also reviewed claims data for more than 280,000 HER2+ breast cancer patients during the same observation period (January 2019 to June 2020) and using the same parameters for claims data (two or more HER2+ breast cancer-related medical claims or one or more HER2+ breast cancer-related medical claims plus a related pharmacy claim). Similar to MS patient data, we observed a marked decrease in use of infusion therapies among the subset of HER2+ breast cancer patients shown to have received treatment from oncologists during the observation period. In fact, the claims data suggest that oncologists may be even more likely to shift away from infused therapies to other routes of administration (such as oral or subcutaneous) compared to neurologists. Among HER2+ breast cancer patients in this claims analysis, there was a significant decline of about 41% in terms of the total number of claims using infusion treatment (including Enhertu, Herceptin, Herzuma, Kadcyla, Ogivri, Perjeta, and Trazimera) from oncologists from February to June 2020.

Figure 2. Changes in Prescribing by Specialty

Source: CRA claims data analysis (using claims through June 2020)

Our analysis represents a preliminary review of the impact of COVID-19 on prescribing habits among physicians including specialists. Given the specialised focus in the analysis and the nature of the data, there are caveats associated with using this data source; these may include under-representation of in-patient claims, limited coverage of certain mail-order channels and specialty pharmacies, and the uncertainty of claims capturing for some patient populations.

Impact on patients

Physicians are also adjusting to the impact of COVID-19 on their patients, including patient anxiety and personal finances. More than half of the surveyed physicians in the market research data reported higher patient anxiety due to COVID-19, and most pulmonologists (77%) and oncologists (66%) also reported that patients often contact them with COVID-19-related concerns or questions. They indicate that financial anxiety is likely exacerbating patient anxiety. Many physicians also reported seeing an increase in issues related to financial difficulties among their patients, such as:

  • discontinuing or skipping medications due to cost (45% of physicians)
  • no longer being able to afford prescribed medications (41% of physicians)
  • losing insurance (e.g. through non-employment) (40% of physicians)
  • requesting cheaper medications such as generics (35% of physicians)

As the pandemic’s toll on the economy continues, physicians will likely see themselves having more difficult conversations with their patients surrounding medication management and affordability. Being aware of these trends can help physicians prepare their practices to better address such issues. For example, practices may collaborate with pharmaceutical companies to make it easier to help patients find and enroll in financial support programmes.

Taken together, all findings thus far indicate that COVID-19 may be affecting the way physicians prescribe medication and interact with patients, among other impacts. Based on our survey, physicians also cite likely trends such as increased virtual medical conferences and fewer visits with sales representatives, with both outlets possibly becoming less predominant sources of product development information.

In recognition of potential systemic changes in the delivery and access of healthcare services, physicians will continue to adapt their practices to the new environment to address both internal and patient concerns. This may require education from and communication with pharmaceutical companies and other industry stakeholders moving forward. Acknowledging that temporary changes including prescribing changes may become permanent and preparing for this shift can better position HCPs and their practices to succeed in the post-COVID-19 era.

About the authors

Kristen Backor, PhD, is director of the market research Center of Excellence at CRA, providing guidance and oversight for projects concerning customer insights and qualitative and quantitative research assessments.

Eddie Li is director of the Analytics Center of Excellence at CRA, where he specialises in market assessment, promotional response modelling, customer segmentation and patient finding.

Jing Li is a senior associate in the Analytics Center of Excellence at CRA with significant experience in analysis of pharmaceutical claims data.

Elizabeth Rountree is a vice president at CRA with 20+ years of customer insights experience (data analytics, primary market research) in biopharmaceuticals as well as in-depth expertise in neurology and oncology.

Billy Wang is an associate at CRA who has been helping clients define COVID-19 focused strategies since the beginning of the pandemic.

The views expressed herein are the authors’ and not those of Charles River Associates (CRA) or any of the organisations with which the authors are affiliated.

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FDA approves first extended-release injectable, complete regimen for HIV

person being given an injection into their upper armThe US Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month. 

The agency also approved Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said Dr John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”

The safety and efficacy of Cabenuva were established through two randomised, open-label, controlled trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA <50 copies/milliliter) before initiation of treatment with Cabenuva. Patients in both trials continued to show virologic suppression at the conclusion of each study and no clinically relevant change from baseline in CD4+ cell counts was observed. 

The most common adverse reactions with Cabenuva were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.

The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

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President Biden announces intention for US to remain member of WHO

WHOThe US has stated that it will remain a member of the World Heath Organization (WHO). US President Joe Biden wrote to António Guterres, Secretary-General of the United Nations (UN), to announce this intention in a letter

On 6 July 2020, the US notified the UN that it intended to leave the WHO, however the new letter retracts this withdrawal. 

“The WHO plays a crucial role in the world’s fight against the deadly COVID-19 pandemic as well as countless other threats to global health and health security. The US will continue to be a full participant and a global leader in confronting such threats and advancing global health and health security,” Biden wrote in his letter to the UN. 

Responding to the letter, Dr Jeremy Farrar, Director of Wellcome, said: “It is brilliant news that the US is committed to re-joining the WHO, as well as joining the COVAX Facility and the Access to COVID-19 Tools (ACT) Accelerator. We need solidarity now more than ever. Strong US collaboration on the international stage will be key to ending this pandemic as quickly as possible and improving the lives of millions of people worldwide. 

Farrar emphasised that the fastest way out of the current pandemic is through collaboration and he urged the US administration to immediately invest in the global COVID-19 response through the ACT-Accelerator, to help ensure that fair access to COVID-19 vaccines, treatments and tests. 

“All international leaders must deliver on ensuring global access and supply of the first COVID-19 vaccines. It is in no country’s interest to focus only on national populations. This is a global, endemic infection, which will require ongoing global surveillance and response for years to come. Leave one country behind and we are all exposed to risk and to life taking longer and longer to returning to anything like normal,” said Farrar. 

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Thrombocytopenia Drugs Market: What Newer Agents Are Expected To Enter The Market?

The launch of a novel drug in the market is not less than a celebration in the pharmaceutical and healthcare market; however, it also brings the real challenge of sustenance in the market. Similar is the picture of the Thrombocytopenia Drugs Market. Thrombocytopenia pipeline possesses potential drugs in mid-stage developments to be approved shortly. There are newer agents coming to the market, for instance, Fc receptor via monoclonal IgG antibodies mechanism, BTK [Bruton tyrosine kinase] inhibition, and so on, however, the real challenge lies in the compliance in terms of patients perspectives such as cost and tolerance.

At present, there stands no treatment option that can cure the disease. The treatment varies on the basis of its cause and severity with the ulterior motive to prevent the death and disability that is frequent in patients due to excess bleeding. 

Thrombocytopenia, a condition characterized by low platelet count, can either be inherited or can also be acquired in due course of one’s life owing to several factors that range from aplastic anaemia to leukaemia. In these cases, there exist drugs causing Thrombocytopenia, known as  Drug-induced Thrombocytopenia (DIT). Nevertheless, sometimes there are cases in which the cause of the disease remains under the covers. Drug-induced Thrombocytopenia (DIT) is relatively a common clinical disorder in patients. Thus, it is imperative to rapidly identify and remove the offending agent before the excess bleeding.

In cases of inherited Thrombocytopenia, platelet transfusions are carried out; however, there is always high chances of sensitization. However, with the availability of leukoreduction, the risks are averted. In cases of the high risk of marrow failure or a high risk of acute leukemia, allogeneic stem cell transplantation is prescribed. 

In most acquired cases, surgical and invasive procedures successfully manage to resolve the platelet count. The mainstay of Thrombocytopenia treatment is plasmapheresis with plasma replacement. Other treatment modalities in non-responders to plasmapheresis include immune-suppression, not limited to high dose steroids and B-cell depleting agents (e.g., rituximab). A fully normal platelet count is not necessary to prevent bleeding, even with severe cuts or accidents.

Another obvious treatment in the case of drug-induced Thrombocytopenia is to stop or discontinue the drug causing it. Hundreds of drugs have been identified to implicate decreases platelet count in the patients. Most often associated drugs causing Thrombocytopenia include heparin, cinchona alkaloid derivatives (quinine and quinidine), penicillin, sulfonamides, non-steroidal anti-inflammatory drugs (NSAIDs), anticonvulsants, antirheumatic and oral antidiabetic drugs, gold salts, diuretics, rifampicin and ranitidine along with several others that are often the culprits occasionally. (Drug-Induced Thrombocytopenia, Gian Paolo Visentin, Chao Yan Liu)

Albeit, in the past two decades, a lot has been learnt and understood about the etiology of the pathogenesis of Drug-Induced Thrombocytopenia, the knowledge of the molecular nature of the drugs, immune-response to the drugs and the production of antibodies in the body is far from complete. Here again, what makes the condition difficult to address is the unclear etiology of Thrombocytopenia in most cases. 

In the case of severe bleeding, if the etiology of Thrombocytopenia is unknown but not thought to be immunologic, platelet transfusion can be used to provide an immediate platelet increase. If the cause of Thrombocytopenia is unknown, and there are no contraindications, such as infections, corticosteroids may be used to increase the platelet count. Other supportive measures include high dose intravenous immunoglobulin, a brief course of corticosteroids. If the condition is mild, the patient may not require any form of treatment. 

The Thrombocytopenia drugs market size in the 7MM (the US, EU5 (the UK, Germany, France, Italy and Spain) and Japan) is expected to grow at a CAGR of 4.69%, for the study period of 2018–2030. The growth of the market size can be labelled pretty much modest as the demand of the novel drugs can be witnessed rising owing to no available cure in the Thrombocytopenia treatment market. 

Major key players involved in developing novel Thrombocytopenia treatment drugs market include UCB BiopharmaPrincipia Biopharma, Baxalta/TakedaArgenx, etc. hold the potential to create a significant positive shift in Thrombocytopenia market size. Expected launch of upcoming therapies, Rozanolixizumab (UCB7665); Rilzabrutinib (PRN-1008); BAX930; Efgartigimod (ARGX-113); Cablivi (caplacizumab); Tavalisse/Tavlesse (Fostamatinib); Doptelet (Avatrombopag); Nplate (Romiplostim)-for CITand Mulpleta (lusutrombopag) is, without a doubt, going to give the market size growth a much-appreciated push. 

UCB Biopharma is working to develop Rozanolixizumab (also known as UCB7665), an intravenously and subcutaneously administered, investigational humanized monoclonal IgG antibody for the treatment of idiopathic thrombocytopenic purpura and myasthenia gravis (MG). At present, the company is evaluating this molecule in the phase III stage of development in subjects with primary Immune Thrombocytopenia (ITP). The company expects topline the phase III trial results by the second half of 2022. 

Principia Biopharma is also developing Rilzabrutinib (PRN-1008), an orally administered reversible covalent inhibitor of Bruton Tyrosine Kinase (BTK). The drug candidate is a fast-acting, orally available therapy that could effectively and safely modulate B-cell function without depleting the B-cells and is expected to be a major advancement in treating autoimmune and inflammatory diseases. It is under development by Principia Biopharma and is currently in the phase III stage of development for the treatment of Immune Thrombocytopenia in adults and adolescents with persistent or chronic Immune Thrombocytopenia (ITP).

TAK-755 (BAX930/SHP655) is a human recombinant ADAMTS13, the plasma metalloprotease that regulates the von Willebrand Factor (VWF) multimers. The drug provides an alternative to the current replacement of ADAMTS13 using large volumes of fresh frozen plasma that contain variable amounts of ADAMTS13 and typically require two hours or more for the preparation and infusion.

Efgartigimod (ARGX-113) is an investigational therapy for IgG-mediated autoimmune diseases, designed to leverage the natural interaction between IgG antibodies and the recycling receptor FcRn. Argenx, designed efgartigimod to degrade circulating disease-causing autoimmune antibodies and has potential in many large and orphan indications, namely multiple sclerosis, immune Thrombocytopenia, systemic lupus erythematosus, myasthenia gravis, and skin-blistering diseases. The drug is currently in Phase III trial for adult patients with primary ITP. 

GC5101B is a polyvalent intravenous human immunoglobulin G preparation. It is prepared from plasma collected from more than 1000 healthy blood donors, and it expresses a large spectrum of antibody specificity. GC5101B is designed to replace the therapy for the primary immune deficiency (PID) as well as increase platelet counts and prevent bleeding in immune/idiopathic thrombocytopenic purpura (ITP). This product is manufactured using three steps designed to eliminate viruses; Fraction III precipitation, SD virus inactivation, and nano-filtration. 

Narsoplimab (OMS721) is an intravenous, human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. This novel drug is designed to prevent complement-mediated inflammation and endothelial damage while maintaining the respective functions of the other pathways of innate immunity. The EC also granted narsoplimab designation as an orphan medicinal product for treatment in hematopoietic stem cell transplantation. According to the clinical trial website, the drug is in Phase III studies, but the status is unknown.

To sum it all, upcoming pipeline therapies in the Thrombocytopenia drugs market are based on novel mechanisms of action that aims to target several different Thrombocytopenia patient groups. The pharmaceutical companies in the market are focusing more on improved drug delivery to enhance patient compliance. Undoubtedly, recent approvals of MulpletaDopteletTavlesse, and Rituxan have substantially increased the market share. However, the drugs approved in the Thrombocytopenia drugs market, say Mulpleta, are kept in Tier 5 by the Medicare, which implies that these are usually non-preferred brand-name drugs and cost more than those kept in other Tiers. Further, the market is not immune to late-stage clinical failures, which poses to be a great hurdle, rather, a constraint that can act out and hamper the revenue generation. Thus, future research in the Thrombocytopenia drugs market needs to revolve around the targeted therapies that are in line with patient tolerance and financial aspects.

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NICE rejects BMS’ Zeposia MS pill in provisional guidance

NICE has said that the NHS should not fund Bristol-Myers Squibb’s multiple sclerosis pill Zeposia (ozanimod) for relapsing multiple sclerosis in first draft guidance.

The cost-effectiveness body said that trial evidence showed Zeposia cuts the number of relapses and brain lesions compared with Biogen’s Avonex (interferon beta-1a).

But in its first draft guidance NICE said that Zeposia’s effect on progression of disability is unclear.

NICE also noted the range of other disease-modifying drugs already available, oral rivals Novartis’ Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) from Biogen.

There are also some powerful injected drugs on the market such as Roche’s Ocrevus (ocrelizumab), Sanofi’s Lemtrada (alemtuzumab).

In its guidance, NICE did not give details of cost-effectiveness estimates because of confidential commercial arrangements for Zeposia and comparators.

But NICE said that the drug was likely to fall outside its cost-effectiveness threshold of £30,000 per Quality Adjusted Life Year (QALY).

There was also no analysis supporting Zeposia’s use as a second-line treatment.

Along with other technical data, NICE said it wanted to see data comparative with other second line treatments such as Lemtrada and Gilenya.

In a statement, the MS Society said it was “frustrating” that NICE had decided not to recommend funding for Zeposia.

Dr Sara Rawlings, director of research and external affairs at the MS Society said: “While there are a range of treatments for this form of the condition, oral options are limited, and people could benefit enormously from a new, more convenient alternative.

“NICE’s decision isn’t final, and we are urging them and the manufacturer to review the evidence and consider what’s best for those living with MS. Ozanimod would be the only oral first-line treatment for some people with relapsing MS, and we are hopeful both sides will act on the significance of this.”

Zeposia is important to patients because it doesn’t cause the unpleasant gastrointestinal side effects associated with Biogen’s Tecfidera.

Rawlings pointed out that there is still time for NICE to change its mind if BMS submits new evidence.

The guidance applies only to England and Wales and in most cases Northern Ireland. A decision is expected from the Scottish Medicines Consortium next month.

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ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Shots:

  • The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen in those who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen
  • Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for ~1mos. to assess the tolerability of each therapy. The therapy reduces the treatment dosing days from 365 days to 12days/ yr
  • The company will begin shipping of Cabenuva to wholesalers and specialty distributors in the US in Feb’2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: ViiV Healthcare

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Health Issues Carried Weight on the Campaign Trail. What Could Biden Do in His First 100 Days?

Joe Biden ran on an expansive health care platform during his 2020 presidential campaign, with a broad array of promises such as adding a government-sponsored health plan to the Affordable Care Act and lowering prescription drug prices. Perhaps most significantly, he pledged to get control of the covid pandemic that claimed more than 400,000 American lives by Inauguration Day.

President Biden now faces major challenges in accomplishing his health care agenda; among the biggest will be bridging partisan divides in both Congress and the nation at large.

Even with the Democrats’ newfound majority in the Senate — the result of victories by the Rev. Raphael Warnock and Jon Ossoff in Georgia’s runoff elections — differences in health policy between the party’s moderate and progressive wings will persist.

“With razor-thin Democratic majorities in both the House and the Senate and many other priorities in addition to health care, Biden is unlikely to succeed in accomplishing all of his health agenda,” said Larry Levitt, executive vice president for health policy at the KFF. (KHN is an editorially independent program of KFF.)

Still, Democratic control of the Senate will allow Biden to pursue some of his health care priorities “using a two-pronged strategy of legislation and executive actions,” Levitt said.

PolitiFact and KHN teamed up to analyze Biden’s promises during the 2020 presidential campaign and will monitor his policies over the next four years to see which ones materialize. But, for now, as Biden settles into the West Wing, what are his chances of making progress on health care?

The Covid Pandemic

In his first 100 days in office, Biden has promised to get 100 million doses of covid vaccine in the arms of Americans and — if Congress provides the funds to do so — get all kids back into schools safely. He asked people to wear face masks in public for those 100 days. He also has repeatedly promised he would get the covid pandemic under control.

Other covid promises include a pledge to double the number of drive-thru testing sites and create a national pandemic testing board. He said he wants to invest $25 billion in covid vaccine distribution and to ensure that every American has access to the vaccine at no cost. He’s also promised to use the Defense Production Act to ramp up personal protective equipment supplies and restore national stockpiles.

During his first two days in office, Biden took steps to accomplish these goals, using executive orders to put in place masking mandates regarding federal buildings and interstate travel — for example, in airports and on commercial aircraft, trains, ferries and intercity bus services — and re-engaging the United States with the World Health Organization. He also issued orders to create a covid response coordinator who will lead the federal government’s efforts for providing vaccination, testing and supplies, set up a national pandemic testing board, establish international travel protocols, use the Defense Production Act to provide necessary supplies and ensure minority communities are provided resources to combat the disease. The White House released a 200-page plan on Thursday that outlines the Biden administration’s strategy to address the covid-19 pandemic.

Some members of his covid leadership team — such as Jeff Zients, tapped to coordinate the White House’s covid response, and Dr. Rochelle Walensky, who will lead the Centers for Disease Control and Prevention — don’t require Senate confirmation, meaning they can get to work right away. But Biden’s pick for Health and Human Services secretary, Xavier Becerra, will need approval by the Senate, a step that will likely be eased because of Democrats’ Georgia victories. Still, how his nomination plays out — as well as Biden’s other selections for posts that require confirmation — could be an early sign of whether the new administration will face strong partisan resistance.

While the executive orders are strong signals of what Biden hopes to accomplish, he will need Congress to fund his plans to expand testing and vaccine distribution. Biden outlined the week before his inauguration in a $1.9 trillion proposal to address covid and the economy. However, the president could face difficulty in getting bipartisan agreement on this plan, with some Republicans criticizing it as too expensive.  It took Congress seven months to pass a second covid relief bill in December.

Other limiting factors include whether the supply of vaccine is adequate to reach 100 million doses and whether organized efforts are put in place to increase testing and ramp up production, said Dr. Georges Benjamin, executive director of the American Public Health Association.

One area in which Biden could face pushback: mask-wearing. Even though he has already issued executive orders regarding mask use in federal buildings, for instance, broader mask mandates fall under individual governors’ authority, and some Republican state executives remain resistant.

Even if Biden makes inroads on that front, Americans will have to accept this step as part of their daily lives. A December KFF survey showed that while most Americans, regardless of party, wear a mask whenever they leave their house, there is still a lag among Republicans.

“I think Biden’s biggest challenges in fulfilling his covid goals are in bringing a divided country together with the bully pulpit of the presidency,” said Levitt. “If testing and the vaccine and mask-wearing are successful in only blue America, then it will be hard to succeed overall.”

Health Insurance

As Barack Obama’s vice president, Biden was instrumental in the enactment of the Affordable Care Act, which expanded health insurance coverage to millions of people but has drawn fierce Republican opposition.

Biden’s health agenda promises to expand the ACA and undo many of the steps taken by President Donald Trump to dismantle it.

“I’ll not only restore Obamacare, I’ll build on it. You can keep your private insurance. If you like it, you can choose a Medicare-like public option,” Biden said during a campaign event in Pittsburgh on Nov. 2.

Adding a government-run public option to other ACA health care plans is one of Biden’s most ambitious pledges. It’s a controversial idea even within the Democratic caucus, where some members want instead to move to a single-payer health plan like “Medicare for All.” Remember the debates during the Democratic presidential primary?

Health policy experts we consulted said implementing a public option seems extremely unlikely in the current environment. So does lowering the Medicare eligibility age from 65 to 60, another divisive idea among Democrats. But both moderates and progressives — even lawmakers across the aisle — might be able to come together on initiatives that could shore up the ACA and make coverage more affordable, such as expanding eligibility for premium subsidies.

Biden doesn’t need Congress to restore parts of the ACA that were changed via regulations issued by the Trump administration. He can instruct agencies to issue new rules that would reverse such Trump initiatives as allowing states to implement work requirements for some adults who gained Medicaid coverage in the ACA expansion of that program. Still, regulatory changes take time. And, in some cases, altering them can be complicated.

Take, for instance, the Trump administration’s rules promoting short-term or association health plans. That metaphorical cat is already out of the bag, said Joseph Antos, a health care scholar at the American Enterprise Institute.

“There are a lot of people insured through those plans and so [changing that policy is] a very tricky thing,” said Antos. “I don’t think it would be wise for him to do anything to reverse that [rule] even though there has been a lot of noise from the left.”

In Antos’ view, the main advantage in gaining Senate control will be helping speed confirmation for key nominations, “which opens the door to new thinking on regulations.”

Drug Prices

On the campaign trail, Biden made clear his intent to bring down prescription drug prices. He promised to lower costs by 60%. Among the related policy ideas he floated: repealing the law that bars Medicare from negotiating lower drug prices and allowing the importation of prescription drugs from other countries.

But details of these proposals aren’t yet available, leaving some experts to question their feasibility.

Of course, the pharmaceutical lobby won’t be enthusiastic about any drug pricing legislation and would likely mount an aggressive campaign to defeat it. And just as with any other proposal, there will be the hurdle of getting Congress to agree on what to include in a drug pricing bill. Plus, given the rapid development of covid vaccines, Capitol Hill may be more sympathetic to the drug industry.

But Stacie Dusetzina, an associate professor of health policy at Vanderbilt University, said it’s possible Biden could succeed in lowering drug prices by limiting drug price increases to the rate of inflation and capping out-of-pocket spending for seniors covered by Medicare.

Both the House and Senate included similar proposals in past drug pricing bills, she said, and “those are both things I think could legitimately move forward, if anything moves forward.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Trump’s Pardons Included Health Care Execs Behind Massive Frauds

At the last minute, President Donald Trump granted pardons to several individuals convicted in huge Medicare swindles that prosecutors alleged often harmed or endangered elderly and infirm patients while fleecing taxpayers.

“These aren’t just technical financial crimes. These were major, major crimes,” said Louis Saccoccio, chief executive officer of the National Health Care Anti-Fraud Association, an advocacy group.

The list of some 200 Trump pardons or commutations, most issued as he vacated the White House this week, included at least seven doctors or health care entrepreneurs who ran discredited health care enterprises, from nursing homes to pain clinics. One is a former doctor and California hospital owner embroiled in a massive workers’ compensation kickback scheme that prosecutors alleged prompted more than 14,000 dubious spinal surgeries. Another was in prison after prosecutors accused him of ripping off more than $1 billion from Medicare and Medicaid through nursing homes and other senior care facilities, among the largest frauds in U.S. history.

“All of us are shaking our heads with these insurance fraud criminals just walking free,” said Matthew Smith, executive director of the Coalition Against Insurance Fraud. The White House argued all deserved a second chance. One man was said to have devoted himself to prayer, while another planned to resume charity work or other community service. Others won clemency at the request of prominent Republican ex-attorneys general or others who argued their crimes were victimless or said critical errors by prosecutors had led to improper convictions.

Trump commuted the sentence of former nursing home magnate Philip Esformes in late December. He was serving a 20-year sentence for bilking $1 billion from Medicare and Medicaid. An FBI agent called him “a man driven by almost unbounded greed.” Prosecutors said that Esformes used proceeds from his crimes to make a series of “extravagant purchases, including luxury automobiles and a $360,000 watch.”

Esformes also bribed the basketball coach at the University of Pennsylvania “in exchange for his assistance in gaining admission for his son into the university,” according to prosecutors.

Fraud investigators had cheered the conviction. In 2019, the National Health Care Anti-Fraud Association gave its annual award to the team responsible for making the case. Saccoccio said that such cases are complex and that investigators sometimes spend years and put their “heart and soul” into them. “They get a conviction and then they see this happen. It has to be somewhat demoralizing.”

Tim McCormack, a Maine lawyer who represented a whistleblower in a 2007 kickback case involving Esformes, said these cases “are not just about stealing money.”

“This is about betraying their duty to their patients. This is about using their vulnerable, sick and trusting patients as an ATM to line their already rich pockets,” he said. He added: “These pardons send the message that if you are rich and connected and powerful enough, then you are above the law.”

The Trump White House saw things much differently.

“While in prison, Mr. Esformes, who is 52, has been devoted to prayer and repentance and is in declining health,” the White House pardon statement said.

The White House said the action was backed by former Attorneys General Edwin Meese and Michael Mukasey, while Ken Starr, one of Trump’s lawyers in his first impeachment trial, filed briefs in support of his appeal claiming prosecutorial misconduct related to violating attorney-client privilege.

Trump also commuted the sentence of Salomon Melgen, a Florida eye doctor who had served four years in federal prison for fraud. That case also ensnared U.S. Sen. Robert Menendez (D-N.J.), who was acquitted in the case and helped seek the action for his friend, according to the White House.

Prosecutors had accused Melgen of endangering patients with needless injections to treat macular degeneration and other unnecessary medical care, describing his actions as “truly horrific” and “barbaric and inhumane,” according to a court filing.

Melgen “not only defrauded the Medicare program of tens of millions of dollars, but he abused his patients — who were elderly, infirm, and often disabled — in the process,” prosecutors wrote.

Prosecutors said the scheme raked in “a staggering amount of money.” Between 2008 and 2013, Medicare paid the solo practitioner about $100 million. He took in an additional $10 million from Medicaid, the government health care program for low-income people, $62 million from private insurance, and approximately $3 million in patients’ payments, prosecutors said.

In commuting Melgen’s sentence, Trump cited support from Menendez and U.S. Rep. Mario Diaz-Balart (R-Fla.). “Numerous patients and friends testify to his generosity in treating all patients, especially those unable to pay or unable to afford healthcare insurance,” the statement said.

In a statement, Melgen, 66, thanked Trump and said his decision ended “a serious miscarriage of justice.”

“Throughout this ordeal, I have come to realize the very deep flaws in our justice system and how people are at the complete mercy of prosecutors and judges. As of today, I am committed to fighting for unjustly incarcerated people,” Melgen said. He denied harming any patients.

Faustino Bernadett, a former California anesthesiologist and hospital owner, received a full pardon. He had been sentenced to 15 months in prison in connection with a scheme that paid kickbacks to doctors for admitting patients to Pacific Hospital of Long Beach for spinal surgery and other treatments.

“As a physician himself, defendant knew that exchanging thousands of dollars in kickbacks in return for spinal surgery services was illegal and unethical,” prosecutors wrote.

Many of the spinal surgery patients “were injured workers covered by workers’ compensation insurance. Those patient-victims were often blue-collar workers who were especially vulnerable as a result of their injuries,” according to prosecutors.

The White House said the conviction “was the only major blemish” on the doctor’s record. While Bernadett failed to report the kickback scheme, “he was not part of the underlying scheme itself,” according to the White House.

The White House also said Bernadett was involved in numerous charitable activities, including “helping protect his community from COVID-19.” “President Trump determined that it is in the interests of justice and Dr. Bernadett’s community that he may continue his volunteer and charitable work,” the White House statement read.

Others who received pardons or commutations included Sholam Weiss, who was said to have been issued the longest sentence ever for a white collar crime — 835 years. “Mr. Weiss was convicted of racketeering, wire fraud, money laundering, and obstruction of justice, for which he has already served over 18 years and paid substantial restitution. He is 66 years old and suffers from chronic health conditions,” according to the White House.

John Davis, the former CEO of Comprehensive Pain Specialists, the Tennessee-based chain of pain management clinics, had spent four months in prison. Federal prosecutors charged Davis with accepting more than $750,000 in illegal bribes and kickbacks in a scheme that billed Medicare $4.6 million for durable medical equipment.

Trump’s pardon statement cited support from country singer Luke Bryan, said to be a friend of Davis’.

These treatments “involved sticking needles in their eyes, burning their retinas with a laser, and injecting dyes into their bloodstream.”

“Notably, no one suffered financially as a result of his crime and he has no other criminal record,” the White House statement reads.

“Prior to his conviction, Mr. Davis was well known in his community as an active supporter of local charities. He is described as hardworking and deeply committed to his family and country. Mr. Davis and his wife have been married for 15 years, and he is the father of three young children.”

CPS was the subject of a November 2017 investigation by KHN that scrutinized its Medicare billings for urine drug testing. Medicare paid the company at least $11 million for urine screenings and related tests in 2014, when five of CPS’ medical professionals stood among the nation’s top such Medicare billers.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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3 practical steps for improving patient support

Research Partnership’s Emilie Braund and Harrison Gaiger dig down into the top insights pharma companies can harness to make their patient support programmes as powerful as possible.

The pandemic has undoubtedly disrupted the healthcare landscape and amplified the complex factors that influence and shape patient journeys. Findings from our recently published whitepaper ‘Free thinking: The impact of COVID-19 on chronic disease management and the implications for pharma marketing’ revealed that, in the spring of 2020, two thirds of physicians across Europe felt patient management was severely impacted as a result of COVID-19. Remarkably, global health systems have evolved quickly in an attempt to adapt to the crisis and great strides have been made to continue providing patients with the information and care they need. In our research, 89% of physicians across Europe reported replacing face-to-face consultations with virtual consultations during the first wave of the pandemic. However, in some additional research we conducted with healthcare professionals, over two thirds across both the US and EU feel patients are still in need of additional support to help manage their condition.

Patient support programmes (PSPs) can play an integral role in providing such assistance. Well-developed PSPs offer a number of opportunities to improve disease management, optimise treatment pathways and deliver better patient outcomes. Our research found the following patient needs being fulfilled by effective PSPs:

  • Adherence and compliance
  • General education on condition
  • Help with self-care
  • Advice for a healthy lifestyle
  • Advice on own treatment management
  • Psychological support

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Nearly half of UK young people buy meds after consulting “Dr Google”

It’s evident that relying on Google for a health diagnosis isn’t a good idea, but it seems a majority of UK people still do – and even buy medicines based on what they find.

A new UK survey finds that overall 59% of 1,000 respondents Google their health symptom before consulting a doctor, with 16% reporting that as a consequence a condition has gone undiagnosed by a doctor for some time.

Meanwhile, almost half (45%) of the 16-24 age bracket have bought medicines after a diagnosis from “Dr Google”, along with around a third each of 25-34 and 35-44 year olds, according to the poll by vision care company Lenstore.

That’s quite a worrying finding, particularly in light of research published last year that found the accuracy of online symptom-checking websites and apps varied considerably, and only reached the correct diagnosis 36% of the time.

Sometimes, self-diagnosing on the internet can cause more harm than good, according to Dr Chun Tang, a GP at UK private healthcare company Pall Mall Medical.

Some sites are simply unreliable, providing inaccurate or incomplete information that can lead people to “wrong conclusion and wrong directions,” he says.

Meanwhile, websites serving healthcare professionals use terminology that may “cause…confusion and fear in the non-medically trained,” according to Dr Tang, who recommends people only use recognised and reliable websites such as NHS, Cancer Research UK, NICE and the BNF.

That’s backed up by the survey, which found that around 30% of people admitted that Googling a health symptom actually made them feel more anxious, while almost one in four said it had a negative effect on their mental health.

Londoners were the most likely to self-diagnose using a Google search, with 23% always checking symptoms online, whilst at the other end of the spectrum the same proportion of Liverpudlians said they never Googled symptoms.

The reasons for turning to the internet for self-diagnosis are varied, but the survey finds that the most common reason – cited by 40% of people – was simply to be aware of potential problems before seeing a doctor. Another 30% did so to avoid putting pressure on the NHS.

However, an alarming 37% of Brits use their own online self-diagnosis to determine whether they need to see a medical expert or not, which runs counter to medical advice.

Dr Tang advises people who are worried enough to carry out online research make sure they consult a medical professional as well, “whether a pharmacist for minor symptoms or a nurse or doctor for persisting and serious symptoms.”

The post Nearly half of UK young people buy meds after consulting “Dr Google” appeared first on .

Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes

Shots:

  • The P-III BLAZE-2 COVID-19 prevention trial involves assessing bamlanivimab (4,200mg) vs PBO in residents and staff at skilled nursing and assisted living facilities. The 965 &132 COVID-19 negative & positive participants were included in the analysis of 1EPS & 2EPs for assessing prevention & in exploratory analyses respectively
  • The results demonstrated an 80% reduction in risk of contracting COVID-19 in residents. Results for all 2EPs also reached statistical significance in both the overall and resident populations
  • Results from the exploratory analyses showed viral load is consistent with the previous studies

Click here ­to­ read full press release/ article | Ref: Lilly | Image: Reuters

The post Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes first appeared on PharmaShots.

Covid Vaccine Rollout Leaves Most Older Adults Confused Where to Get Shots

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It can be republished for free.

Over a month into a massive vaccination program, most older Americans report they don’t know where or when they can get inoculated for covid-19, according to a poll released Friday.

Nearly 6 in 10 people 65 and older who have not yet gotten a shot said they don’t have enough information about how to get vaccinated, according to the KFF survey. (KHN is an editorially independent program of KFF.)

Older Americans are not the only ones in the dark about  the inoculation process. About 55% of essential workers —designated by public health officials as being near the front of the line for vaccinations — also don’t know when they can get the shots, the survey found. Surprisingly, 21% of health workers said they are unsure about when they will get vaccinated.

Black and Hispanic adults, as well as those in low-income households, are among the groups struggling most to find vaccine information. Within each of those groups, at least two-thirds said they do not have enough information about when they can get vaccinated, the survey found.

The covid vaccines, which were first distributed in mid-December to health care workers and people living in nursing homes or assisted living centers, are now available for other older adults in most states, though age restrictions vary. Ohio, for example, opened up vaccinations to all residents  80 and older. In Virginia, the minimum age for the second wave of shots is 65. In Indiana, it’s 70; Maryland, 75. Some states, such as Florida and Texas, started vaccinating anyone 65 and up in December, though many states did not begin vaccinating all seniors until January.

Limited doses have left many seniors scrambling to get an inoculation appointment.

For example, at 9 a.m. Thursday, Washington, D.C., opened 2,200 covid vaccine appointment slots for people 65 and older in several hard-hit neighborhoods. Within 20 minutes, they were all filled.

To date, more than 15 million Americans have been vaccinated for covid, which has infected 24 million and killed more than 400,000. The two covid vaccines authorized for emergency use by the Food and Drug Administration require two doses either three or four weeks apart.

Despite the rocky rollout of vaccines, two-thirds of respondents were “optimistic” that things will get better.

Sixty-five percent of adults said they believe the distribution of the vaccines is being done fairly, but half of Black adults said they were concerned that the efforts are not adequately considering the needs of the Black community.

The KFF survey of 1,563 adults was conducted Jan. 11-18. The margin of sampling error is plus or minus 3 percentage points.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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This story can be republished for free (details).

WHO platform for pharmaceutical firms unused since pandemic began

Exclusive: ‘pool’ to share Covid-19 information has received no contributions since May 2020

A World Health Organization program for pharmaceutical companies to voluntarily share Covid-19 related knowledge, treatments and technology so they can be more widely distributed has attracted zero contributions in the eight months since it was established, the Guardian has learned.

The Covid-19 technology access pool (C-Tap) was launched in May last year to facilitate the sharing of patent-protected information to fight the virus, including diagnostics, therapeutics and trial data. The “pooling” of treatments and data would allow qualified manufacturers from around the world to produce critical equipment, drugs or vaccines without fear of prosecution for breaching patents.

Related: Global immunisation: low-income countries rush to access Covid vaccine supply

Continue reading…

Boston Scientific to Acquire Preventice for ~$1.2B

Shots:

  • Boston Scientific to acquire Preventice for ~$1.2B including $925M as up front, up to an additional $300M as commercial milestones. However, Boston Scientific has built up a 22% stake in Preventice, which is expected to lower up front to $720M upfront & $230 million in milestone respectively
  • The acquisition is expected to be close in mid-2021. The acquisition will add external cardiac monitoring technologies and services provider to Boston Scientific and expand its rhythm management diagnostics portfolio and capabilities
  • The Preventice portfolio includes the BodyGuardian family of remote, wearable cardiac monitors for adult and pediatric patients

Click here ­to­ read full press release/ article | Ref: Boston Scientific| Image: CRG

The post Boston Scientific to Acquire Preventice for ~$1.2B first appeared on PharmaShots.

Health Insurance Battle Royal: Commercial vs. Medicaid

What insurance is better: private commercial health insurance or public health insurance? This is a more difficult question than it seems since individuals with commercial vs. public health insurance differ over a number of dimensions which affect health care spending, quality and outcomes.

To try and get at this question, a paper by Allen et al. (2021) compare individuals with Medicaid and those on health insurance exchanges. To make individuals more comparable, they use two strategies: (i) limit the sample to non-pregnant individuals aged 19-64 that were within 5 percentage points of the federal poverty level (FPL) cutoff, and (ii) propensity score match individuals that were on Medicaid against those who were commercially insured. With respect to the first point, individuals with income below 138% FPL qualified for Medicaid; those just above qualified for the commercial insurance under the subsidized health insurance exchanges. Under the ACA, this threshold sorts the low-income population lacking employer-sponsored insurance into 2 coverage types

Based on this approach, the authors used 2014-2015 data from the Colorado All-Payer Claims Database and found that:

Marketplace coverage was associated with fewer ED visits (mean, 0.36 [95% CI, 0.32-0.40] visits vs 0.56 [95% CI, 0.50-0.62] visits; P < .001) and more office (outpatient) visits than Medicaid (mean, 2.22 [95% CI, 2.11-2.32] visits vs 1.73 [95% CI, 1.64-1.81] visits; P < .001). No differences in ambulatory care–sensitive hospitalizations were found (0.004 [95% CI, 0.001-0.006] vs 0.007 [95% CI, 0.002-0.011]; P = .15). Total costs were 83% higher in Marketplace coverage (mean, $4553 [95% CI, $3368-$5738] vs $2484 [95% CI, $1760-$3209]; P < .001) owing almost entirely to higher prices, and out-of-pocket costs were 10 times higher (mean, $569 [95% CI, $337-$801] vs $45 [95% CI, $26-$65]; P < .001).

In short, Medicaid cost less, but not necessarily because they use less services, but because prices are lower. So, it’s clear that we should go with Medicaid, right?

Well not necessarily. Quality of care was shown to generally be better among the commercially insured.

Five of 12 secondary quality measures favored private insurance, and 1 favored Medicaid.

One interesting question that was not answered was through what pathway quality improved. Did commercially insured individuals go to higher quality doctors? Did the doctors themselves prioritize commercially insured patients or perhaps were there shorter wait times for commercially insured compared to Medicaid patients? Or did physicians provide different quality of care depending on whether each individual was commercially or Medicaid insured? Or perhaps quality was the same but commercially insured plans better documented quality of care?

The Allen study is interesting but more research is needed in this battle royal.

Biocon reports 17% drop in net profit, Christiane Hamacher steps down as MD of Biocon Biologics

“2020 has been one of the most challenging years for the world with an unprecedented pandemic impact on the global economy. We continue to face headwinds across operational, regulatory and commercial functions which have been deterrents to our planned market expansion. However, we expect normalization by next fiscal,” said Kiran Mazumdar-Shaw, executive chairperson, Biocon.

South Africa paying more than double EU price for Oxford vaccine

Health ministry quotes says premium is because government did not pay into research and development effort

South Africa will have to buy doses of Oxford-AstraZeneca’s Covid-19 vaccine at a price nearly 2.5 times higher than most European countries, the country’s health ministry has said.

The African continent’s worst virus-hit country has ordered at least 1.5m shots of the vaccine from the Serum Institute of India (SII), expected in January and February.

Related: ‘South Africa is going to get a third wave of coronavirus, even a fourth’

Related: Global immunisation: low-income countries rush to access Covid vaccine supply

Continue reading…

How to Meal Plan for Absolute Beginners

You probably know by now that meal planning works for weight loss and can save you time and money.

And before you start shopping or lining up meal prep containers, creating the actual menu for your meal plan is an important first step.

But if you’re new to it all, you may not know how to meal plan. Or, you may think it’s only for super-organized people who alphabetize their spice racks.

That’s not the case at all.

Learning how to create a meal plan is much easier than you think and can work for pretty much anyone.

Here are some tips for successful meal planning that can help get you started.

This easy guide on how to meal plan will make you a meal plan expert in no time!

Woman writing shopping list on paper

1. Look at your lifestyle

“Think about how meals fit into your current routine,” says Cara Harbstreet, M.S., R.D., L.D. “This helps you gain clarity on your goals and expectations, as well as how you can make meal planning sustainable.”

Some reasons for meal planning are saving money, portion control (which also saves money), eating fewer processed foods, or simplifying meal-time decision-making when you’re busy.

Before starting a meal plan, be realistic about how much time you have to prep, cook, clean up, and go to the grocery store.

You may choose to mix home-cooked meals and prepared foods.

Meal plan for a week illustration

2. Start with a week

“If you’re new to meal planning, try tackling a shorter amount of time,” says Harbstreet. “A week is a good starting point.”

Thinking about how to meal plan for the week is doable for most people, but this doesn’t mean you have to cook every day of the week.

Sit down with a calendar, a notebook, a dry erase board, or even your computer and chart out the meals you typically eat each day, such as breakfast, lunch, dinner, and any snacks.

Meal planning happens before you shop for groceries, so that you’re not stuck with a bag of broccoli wilting in your crisper drawer.

3. Fill in the blanks

“Nail down the basics, but stay flexible,” says Rachel Naar, M.S., R.D., C.D.N. “Try to plan meals with four components, a carb, a protein, a vegetable or fruit, and a fat.”

This is the hard part of how to make a meal plan, but it can also the fun part — think of it as a game of Tetris, but with food!

Don’t forget healthy snacks like a nutrient-dense Shakeology smoothie or energy bites to keep your stomach satisfied between meals.

If you’re stumped, go with a daily theme, like Meatless Monday, Taco Tuesday, or Healthy Homemade Pizza Friday.

Roasting a batch of sweet potatoes

4. Work your leftover magic

To save time, choose recipes you can slot in for dinner and lunch the next day, recommends Naar, or freeze portions to carry over into a meal plan for a different week.

Another time-saving hack is choosing recipes with similar ingredients to cut down on meal prep and waste. Seasonal vegetables are also a good source of inspiration.

“Chicken, salmon, rice, and quinoa are some solid staples,” says Naar. “But also work variety into your meal plan.”

Meal prep lunch box containers with salmon, rice, broccoli, asparagus.

5. Keep it simple

The goal of a meal plan is to help you shop wisely and plan ahead, not prove your culinary mastery, explains Naar.

You don’t need to create a weekly menu filled with complicated recipes.

If a snack is a serving of nuts or some carrot sticks and hummus, write that down even if it seems simple or obvious.

You’ll also want to schedule meal prep into your meal plan.

“It’s really about what works for you,” says Naar. “If you have time each day to make dinner, then do that. If you’re busy all day and don’t want to think about cooking, I would suggest batch cooking ahead of time.”

Making a double batch of your favorite dishes yields twice the deliciousness, but usually doesn’t take twice the time. It’s a win-win.

6. Assemble your list

Once you’ve narrowed down your meals, compile your list of ingredients.

It’s also a good time to make sure you have the right equipment for a recipe or enough food containers for the week.

Check off what you already have in your pantry or fridge. Then shop online or head to the supermarket.

To streamline in-person shops, group your list into produce, dried goods, meat and seafood, and frozen.

Now that you know how to meal plan, you’re ready to put that meal plan into action!

Boston Scientific Acquires Preventice Solutions for $925M in Cash

Boston Scientific Acquires Preventice Solutions for $925M in Cash

What You Should Know:

– Boston Scientific announces an agreement to acquire Preventice
Solutions, a leading developer of mobile health solutions and remote monitoring
services that connect patients and caregivers for $925M in cash.

– The acquisition of external cardiac monitoring technologies and services providers will expand Boston Scientific’s rhythm management diagnostics portfolio and capabilities.


Boston
Scientific
today announced that it has acquired
Preventice Solutions, Inc.,
a Minneapolis, MN-based company which offers a full portfolio of mobile cardiac
health solutions and services, ranging from ambulatory cardiac monitors –
including short and long-term Holter monitors – to cardiac event monitors and
mobile cardiac telemetry.

The Preventice product portfolio includes the BodyGuardian®
family of remote, wearable cardiac monitors for adult and pediatric patients.
The monitors use a fully-integrated, cloud-based platform supported by an
independent diagnostic testing facility, where clinical technicians and artificial
intelligence (AI)
algorithms provide insights that may lead to improved
clinical diagnoses and outcomes. Preventice’s integration of AI and human
expertise is designed to enhance physician efficiency and experience.

Financial Details

Under terms of the acquisition, Boston Scientific has agreed
to pay $925M in upfront cash, and up to an additional $300 million in a potential
commercial milestone payment. Boston Scientific has been an investor in
Preventice since 2015 and currently holds an equity stake of approximately 22
percent, which is expected to result in a net payment of approximately $720
million upon closing and a milestone payment of up to approximately $230
million. Preventice recorded net sales of $158 million in 2020 – a 30 percent
growth rate from the previous year.

Acquisition Expands Boston Scientific’s Rhythm Management
Diagnostics Portfolio

“This acquisition will provide Boston Scientific with a foothold in the high-growth ambulatory electrocardiography space, which strongly complements our recent entrance into the implantable cardiac monitor market and will serve as an important component of our category leadership strategy in cardiac diagnostics and services – a nearly $2B market anticipated to grow double digits annually,” said Scott Olson, senior vice president and president, Rhythm Management, Boston Scientific. “We are confident that by adding the broad technology portfolio and expertise of Preventice, our combined teams can continue to deliver rapid growth in these highly-attractive markets while also establishing an important adjacency to our core cardiac rhythm management and electrophysiology businesses.”


Aneesh Chopra: It’s the people problem that remains at the core of cyberattacks

Cybersecurity will continue to be a major issue for providers in the year ahead. According to CareJourney President Aneesh Chopra, the most common factors putting providers at risk are their employees and being unable to track data flow.

Biden Administration Includes ‘Home Care Workforce Crisis’ in New Pandemic Plan

President Joe Biden focused on the ongoing COVID-19 pandemic during his first full day in office Thursday. In doing so, he once again drew attention to home-based care and getting the current “workforce crisis” under control.

“Our national strategy is comprehensive,” Biden said during an address from the White House. “It’s based on science, not politics. It’s based on truth, not denial — and it’s detailed.”

Since taking office, the president has signed 10 executive orders aimed at expanding COVID-19 testing and vaccine availability, with an ambitious goal of 100 million vaccine doses by April. The Biden administration unveiled a nearly 200-page pandemic preparedness plan on Thursday.

Wednesday saw more than 184,000 new cases of COVID-19 infection across the U.S., according to a New York Time database. More than 400,000 people have died since the pandemic began last year.

“Things are going to continue to get worse before they get better,” Biden said.

Biden’s pandemic preparedness plan is organized around seven goals, with the first goal focused on “restoring” trust with the American people. Protecting individuals most at risk — partly by expanding access to high-quality health care — is likewise a main goal under the plan.

“Specific actions include efforts to increase funding for community health centers, provide greater assistance to safety net institutions, strengthen home- and community-based services, expand mental health care, and support care and research on the effects of long COVID,” the plan states.

Dating back to his presidential campaign, Biden has proposed numerous investments in home- and community-based services as part of his plan to “Build Back Better.”

Wednesday’s pandemic plan notes that the U.S. Department of Health and Human Services (HHS) — including the Centers for Medicare & Medicaid Services (CMS) and the Administration for Community Living — will be tasked with identifying “opportunities” and “funding mechanisms” to provide greater support for individuals receiving care at home.

The plan also says that the administration will pay “particular attention” to “the home care workforce crisis.”

Washington, D.C.-based LeadingAge was among the first aging services organizations to voice support for Biden’s COVID-19 response.

“This virus has raged out of control for nearly a year, while our community has desperately called for help,” Katie Smith Sloan, president and CEO of LeadingAge, said in a statement. “So to have the new administration lay out plans on Day 1 to put COVID at the top of its agenda is welcome and hopeful news.”

To better track vaccination progress for seniors in congregate settings, in the community and in their homes, the Biden administration is also floating the idea of new reporting measures.

For example, to increase incentives to vaccinate Medicare beneficiaries, the plan explains, CMS will evaluate how to incorporate quality measures for COVID-19 immunizations into its value-based purchasing programs, including Medicare Advantage Star-Ratings, the physician quality payment program and accountable care programs.

One of the executive orders Biden signed directs cabinet agencies to invoke the Defense Production Act to scale up production of materials needed for vaccine shots.

“In the midst of the virus spiking and community spread, we’ve been on the battlefield trying to protect older adults and workers with limited support,” LeadingAge’s Sloan said. “We hope this means the cavalry is coming, especially on testing and vaccine initiatives.”

Another executive order empowers HHS, the Department of Defense and others to provide “targeted surge assistance” to critical care and long-term care facilities, including nursing homes and skilled nursing facilities (SNFs), plus assisted living facilities and more.

The new pandemic plan follows a couple of key HHS and CMS leadership announcements made earlier in the week.

The new administration on Wednesday tapped Liz Richter to lead CMS on an interim basis during the presidential transition. The agency’s website now lists Richter, who has worked at CMS in various capacities since 1990, as acting administrator.

Former CMS Administrator Seema Verma submitted her resignation last week with an effective date of Jan. 20.

The president on Tuesday nominated Dr. Rachel Levine to serve as assistant health secretary. Levine is currently the Pennsylvania health secretary, and a pediatrics and psychiatry professor at Penn State College of Medicine.

Biden already nominated California Attorney General Xavier Becerra to serve as HHS secretary, though he — along with the administration’s eventual pick for CMS chief — must eventually be confirmed by the Senate.

The post Biden Administration Includes ‘Home Care Workforce Crisis’ in New Pandemic Plan appeared first on Home Health Care News.

How to Organize Your Pantry Like a Pro

Your organization kick is rolling — you’ve cleaned out your fridge and decluttered your freezer, now let’s learn how to organize a pantry.

Whether you have a walk-in pantry with built-in shelves or a roomy cabinet for storing dry goods, a well-organized pantry can speed up meal prep and help you stay on track with your nutritional goals.

According to Leigh Merotto, R.D., MHSc, there are two significant challenges to organizing a pantry:

  1. Minimizing clutter
  2. Maximizing space

“The key is to have a pantry that works best for you,” says Merotto.

Here’s how to turn your pantry into a working part of your kitchen, not a dusty place for dry goods to go forgotten or unused.

1. Start fresh

“It’s good once a year to just empty your pantry, dust off the shelves, and make sure that everything is tightly sealed and stored well,” says Sharon Palmer, M.S.F.S., R.D.N.

Check expiration dates and make sure everything is free of pests or mold.

Since pantry items tend to have long shelf lives, you can have a bug situation without realizing it, especially with open items that have been hanging out for a few months.

To organize a deep pantry, allow approximately two hours, and for a small pantry, around an hour, recommends Merotto.

Plastic containers on pantry shelf

2. Create zones

One of the best strategies for how to organize your pantry is creating zones.

“Group similar items together, such as putting all of your spices in one section, all of your canned goods in one section, and all of your grains in one section,” says Palmer.

The main types of items you typically keep in your pantry are grains, beans and pulses, teas and coffee, and oils. (Pro tip: It’s also a prime spot for stashing your  Shakeology bags!)

If your pantry has an area that is dark and cool, you can also store potatoes, sweet potatoes, onions, garlic, winter squashes, and other perishables that don’t require refrigeration, says Merotto.

3. Take inventory and rotate

One problem with pantries is continually restocking without taking note of what you already have or can’t see (hello, 10 cans of chickpeas).

“If you have double of something, make sure to use up the oldest version first,” says Merotto, “This prevents food waste and can help you save money.”

Rotate items with FIFO (“first in, first out”) in mind and use up older items.

Your pantry cleanup could inspire this week’s meal plan to avoid food waste.

Glass jars filled with kitchen staples on pantry shelf.

4. Stack and label

Storage bins, stackable containers, and lazy Susan organizers can turn a deep pantry into an Instagram-worthy space for sparking joy.

Clear containers are helpful because you can see inside, but you should label similar-looking grains and other staples.

“I use a washable marker to write dates and items on jars and containers,” says Palmer.

5. Assess your space

“With deep pantries, the goal is to avoid things getting lost or unseen in the back, which leads to overbuying or things going bad,” says Merotto.

One simple fix is putting tall items in the back, such as on-deck bottles of olive oil, vinegar, or stacked cans so you can quickly see what you have.

For how to organize a small pantry, you need to think more strategically.

“You can’t stock as many items, so it requires more vigilance,” says Palmer. “For example, you may decide to stock your favorite spice blend instead of five different spice jars.”

6. Organize your snacks

Let’s be honest, one of our favorite reasons to head to the pantry is snacks.

Instead of “hiding” treats in the back, Palmer recommends prioritizing healthier items, such as:

  • whole-grain crackers
  • nuts
  • trail mixes
  • nutrition bars

There are plenty of crave-worthy healthy snacks for post-conference call munchies you can store in your pantry (or fridge).

If you shop in bulk, portion out your healthy snacks into smaller, easy-to-grab containers and store large jars behind them.

“My approach with nutrition is balance, so I suggest stocking a pantry with healthy snacks, and if a couple treats make their way in, enjoy them mindfully,” recommends Merotto.

Jeff Bevis Out at FirstLight: ‘I Still Have a Lot of Fuel in the Tank’

Home care veteran Jeff Bevis founded FirstLight Home Care with his son, Devin, toward the end of 2009. A decade later, his tenure as the franchise giant’s top executive has come to an end.

On Nov. 17, FirstLight’s board of directors informed Bevis that “they wanted to go in a different direction,” the former CEO told Home Health Care News. The decision was effective immediately.

“I had a surprise meeting with our board,” Bevis said. “And they decided they wanted to go a different way than what I would like to see, what I would have liked to continue.”

During his time as FirstLight’s CEO, Bevis helped lead the home care company through a long list of challenges, including the ongoing COVID-19 pandemic and a difficult labor landscape. At times, that leadership meant embracing emerging technologies while also refining new revenue streams such as Medicare Advantage (MA) and employee-assistance programs.

Other noteworthy initiatives that Bevis helped drive include FirstLight’s push to convert independent home care operators into its franchise system. The company’s first independent conversion came in September 2019.

A spokesperson for FirstLight confirmed the leadership change on Thursday.

“We are grateful for Jeff, as he led FirstLight through its first decade of growth,” the spokesperson told HHCN in an email. “We wish him well in his future endeavors. With a rapidly changing industry, FirstLight is positioned to move aggressively, seize pertinent opportunities and take the company to the next level.”

Currently, the Cincinnati, Ohio-based FirstLight has 120 owners operating across 200 territories in 38 states, with another 20 territories in development. Its three-year average growth rate is 74%, according to the 2020 Inc. 5000 list.

As of Thursday, FirstLight has not named a replacement for Bevis, who hopes to continue working in the home care space.

“I do have some non-compete limitations that are fairly narrow,” Bevis said. “But I’ve already had discussions with people contacting me from home care-technology [organizations] that do remote patient monitoring and telehealth — the types of services that are not home care-specific. I think I still have a lot of fuel in the tank.”

The franchiser is in the process of conducting a CEO search.

“We have a strong leadership team and interim management committee in place who are deeply committed to creating the best possible future for the company and our franchisees,” the spokesperson said. “We are committed to our culture of care and are positioned for significant growth as we head into the next decade and beyond.”

Looking back

Bevis and his son registered FirstLight in December 2009, then started franchising the following spring. Instead of following the normal template of opening a flagship location to showcase success prior to selling franchising rights, the co-founders dove right in, Bevis said.

“We started from scratch, as crazy as it sounds,” he recalled. “We just had an idea, a concept. We kind of broke the franchising rule of normally having an operating location first, which serves as your proof of concept.”

Devin Bevis remains in his FirstLight role of executive director of franchise services, according to the company’s website.

After setting up shop, FirstLight expanded to 19 locations in its first full year. Originally, the plan was to have a concentrated footprint in the Midwest, but that plan didn’t play out as expected.

“We thought we would have a Midwest footprint, but our first franchise was awarded in Florida,” Bevis said. “So that put that whole theory out the window.”

FirstLight grew steadily over the next five years, expanding to dozens of locations in several states. Last year, it even expanded into Canada.

Apart from its history of innovation and commitment to franchisee satisfaction, it’s that track record of growth that Bevis is particularly proud of.

“The growth has been solid from the 2010 start,” he said. “We didn’t have the weaknesses or the issues with peaks and valleys, which is what you typically see in some franchise systems. They’ll have like two to four years of fast growth, then a ton of closings because they were just trying to sell franchises as fast as possible.”

Prior to co-founding FirstLight, Bevis held an executive role at Comfort Keepers from about 2003 to 2007. After helping grow Comfort Keepers to about 600 units, he left when the organization changed ownership.

He formed FirstLight after doing international consulting work related to home care.

“I thought, you know, there’s really still more to be done in the home care space,” Bevis said. “I’ve been a caregiver four times in my life, so that continuing experience led me to feel like I could get back in the industry and make a difference.”

‘So much potential ahead of us’

There’s a lot to like about home care and where the industry is headed, Bevis said, but there are still plenty of frustrations. One of the biggest for him is how home care remains somewhat on the outside of health care looking in, even after proving its mettle during the COVID-19 pandemic.

“There’s still the ongoing perception of home care being the [odd man out],’” Bevis said.

Another point of frustration has been how home care agencies have had to fight for every inch of ground gained with third-party payers. Bevis hopes that will change as more Medicare Advantage (MA) plans embrace in-home care and social determinants of health as part of their supplemental-benefit design.

Overall, at least 920 plans are participating in the “Special Supplemental Benefits for the Chronically Ill” MA pathway in 2021, an ATI Advisory analysis of Centers for Medicare & Medicaid Services (CMS) data shows. Broadly, that pathway allows MA plans to offer benefits focused on anything that helps chronically ill individuals stay in their homes and out of the hospital.

“Back in 2003, we were saying, ‘Oh, gosh. Wouldn’t it be great if CMS recognized the benefits of home care?’” Bevis said. “Now we have at least a little bit of that, with CMS sticking its toe in the water with supplemental benefits. I think that’s going to speed up.”

On top of payer-related challenges, the home care industry must find ways to better navigate the labor landscape, he added, especially as agencies compete with higher-paying employers in less demanding job sectors.

Standing behind consistent industry quality standards will also be important moving forward.

“Home care has so much potential ahead of us,” Bevis said. “I think a big part of the future will be industry standards, trying to get more [operators] to accept or adopt quality standards.”

Although Bevis is leaving FirstLight, he’ll remain a minority equity holder, he noted.

“I certainly wish the brand all the best,” Bevis said.

The post Jeff Bevis Out at FirstLight: ‘I Still Have a Lot of Fuel in the Tank’ appeared first on Home Health Care News.

87% of Americans Want to Receive COVID-19 Vaccine Information From Their Providers

87% of Americans Want to Receive COVID-19 Vaccine Information From Their Providers

What You Should Know:

According to a recent Updox survey, 87% of Americans say
they want to receive information from their healthcare provider on COVID-19
vaccine-related news/updates, with their healthcare providers cited as the most
trusted source on the topic (34%) — behind health protection agencies (32%),
government entities (9%), and the biotechnology companies developing the
vaccines (4%).

When it comes to means of communication with their
healthcare provider, consumers’ preferred method for receiving COVID-19 vaccine
news and updates is by email (46%), followed by phone call (34%) and text
message (33%).


Majority of Americans say they want to receive COVID-19 vaccine-related
news/updates from their healthcare providers, according to a recent result of a
study by Updox. The survey designed to
better understand the public’s view on the COVID-19 vaccine was conducted
online by The Harris Poll on behalf of Updox among 2,057 U.S. adults aged 18+.

Updox finds that 87% of Americans say they want to receive
information from their healthcare provider on COVID-19 vaccine related
news/updates, with their healthcare providers cited as the most trusted source
on the topic (34%) — behind health protection agencies (32%), government
entities (9%), and the biotechnology companies developing the vaccines (4%).
When it comes to means of communication with their healthcare provider,
consumers’ preferred method for receiving COVID-19 vaccine news and updates is
by email (46%), followed by phone call (34%) and text message (33%). 

The survey key findings underscore the strong need for more frequent communications between healthcare providers and patients and demonstrates the critical role technology plays in ensuring an effective vaccine rollout, with information such as vaccine education, eligibility, and scheduling.

Additional key findings of the survey include:

– Americans ages 55-64 are more likely than those ages 18-34
and 65+ to say they would like to ask questions or receive communications from
their healthcare provider regarding vaccine-related news and updates via their
patient portal (34% vs. 17% and 24%)

– 28% of Americans would like to hear from their pharmacist
about COVID-19 vaccine-related news and updates weekly or more often

– Males are more likely than females (44% vs. 33%) to say
they would like to receive vaccine-related news and updates from their
healthcare provider weekly or more often

Why It Matters

“As millions of Americans await their turn to receive the
critical COVID-19 vaccine, the entire healthcare industry is working diligently
to ensure effective communications between providers and patients surrounding
distribution, while simultaneously facilitating safe, efficient delivery of
immunizations,” said Michael Morgan, president, Updox. “But these efforts must
be taken a step further. Nearly 2 in 5 Americans would like to hear from their
healthcare provider weekly or more often about the vaccine, demonstrating that
even if providers are not the ones physically distributing the vaccine,
patients rely on them for insights and information. Physicians play a role more
vital than ever before as trusted resources for their patients in today’s
healthcare environment. Consistent communications both inside and out of the
office is key.” 

Home Health Transaction Numbers Continue to Climb

Last fall, the home health M&A winds started to shift, with some industry insiders even predicting a record number of transactions to soon follow.

New data suggests that point has arrived.

Most had gone into 2020 believing that the Patient-Driven Groupings Model (PDGM) would jump start a period of “historic” M&A activity, but that ultimately didn’t play out. In fact, early on in the year, dealmaking largely froze due to coronavirus-related operational uncertainty.

In the fourth quarter of 2020, however, there were at least 17 home health care-related transactions, according to a new report from M&A advisory firm Mertz Taggart. That was the same number of transactions as the third and second quarters combined — and more transactions than any individual quarter since the 18 in Q3 2018.

“My crystal ball is clouded somewhat, with an election less than a month away and a threat of another significant COVID outbreak,” Mertz Taggart Managing Partner Cory Mertz told Home Health Care News in October. “But I’m going to go out on a limb and speculate we will see near-record — if not record — home health M&A activity between Q4 2020 and Q1 2021.”

In its M&A report, Mertz Taggart explains there has been plenty of pent-up demand for home health assets, particularly as payers and health systems look to shift care away from institutional settings.

Across the home health, hospice and home care landscapes, there were at least 51 transactions in Q4 2020. While home health dealmaking was way up, hospice transactions still dominated the headlines.

At least 25 hospice transactions occurred during the fourth quarter, exceeding the 19 reported deals in Q3. At least 15 hospice deals have taken place per quarter since the end of 2019, according to Mertz Taggart.

“Deal volume started to recover or trend upward across the home health, home care and hospice markets toward the middle of 2020,” Mertz noted in his firm’s report. “It seems like every quarter we’re saying demand for hospice is at an all-time high — and then we see even more demand materialize.”

So far, there are no signs of home health dealmaking slowing down in 2021.

Earlier this week, Eagle, Idaho-based The Pennant Group (Nasdaq: PNTG) announced it acquired Sacred Heart Home Health Care, which provides home health services in Phoenix and Tucson, Arizona.

Additionally, College Station, Texas-based Traditions Health announced toward the start of the month that it acquired two Oklahoma home health providers: Traditions Home Care and Secure Home Care.

“This announcement is a fitting way to cap off what’s been an exciting year for Traditions Health,” President and CEO Bryan Wolfe said in a press release announcing the news.

Also in January, Chicago-based Help at Home reportedly acquired The Adaptive Group, a home health, hospice and home care services provider that operates across Indiana.

Besides shaping up to be a record year for sheer volume, 2021 also has the potential to be a very interesting year in terms of individual deal size.

Encompass Health Corp. (NYSE: EHC) has confirmed that it’s exploring strategic alternatives for its home health and hospice segment, with Brookdale Senior Living Inc. (NYSE: BKD) reportedly doing the same.

The post Home Health Transaction Numbers Continue to Climb appeared first on Home Health Care News.

Why Do I Feel Bloated After Eating?

Maybe your clothes don’t fit right, your stomach seems fuller than it did yesterday, or you just don’t feel quite like your usual self.

Whatever the feeling, bloating after eating can be a big bummer — and it’s only natural to want to ditch the bloat, especially if it comes with excessive gas or burping.

While it might feel like you’re alone in feeling this way, the truth is that bloating is very common, says Jesse P. Houghton, M.D., F.A.C.G., senior medical director of gastroenterology at Southern Ohio Medical Center.

The good news? “It’s not usually a sign of anything dangerous, but it can be quite bothersome and can even disrupt your daily life,” he adds.

Luckily, there are things you can do to banish bloating after eating.

Symptoms of Bloating After Eating

Most of the time you know if you’re experiencing bloating. Warning signs include:

  • feeling full
  • belching or flatulence
  • indigestion or stomach discomfort
  • rumbling or gurgling in your stomach

Woman sitting on bed with stomach cramps

Why You Feel Bloated After Eating

Bloating occurs for various reasons, but it’s especially common after eating, due to how our bodies digest food.

“Some foods cause excess gas production due to various compounds they contain,” says Bansari Acharya, M.S., R.D.N., a registered dietitian nutritionist and blogger at FoodLove.

“When they are digested, they produce gaseous by-products like hydrogen, carbon dioxide, and methane gas,” she explains.

Broccoli, beans, Brussels sprouts, and whole grains are examples of high-fiber foods known for causing gas.

“Fruits that are high in fiber, like apples, can also lead to bloating,” adds Acharya.

Some people will bloat after eating certain foods due to a lack of specific enzymes to break down specific food components.

Lactose intolerance, for example, is linked to inadequate lactase to break down milk sugar, which leads to gas, says Acharya.

Even seemingly unrelated habits, like drinking carbonated beverages, chewing gum, and smoking can be culprits because they cause excessive gas to build up in the stomach and intestines.

Overhead photo of broccoli stems in a bowl

How to Avoid Bloating After Eating

While you might feel destined to deal with discomfort, there are ways to reduce or even avoid bloating after eating altogether.

1. Don’t overdo it on fiber

While there are numerous health benefits to adding fiber to your diet, it’s a good idea not to eat too much at once.

“Spreading out your fiber intake throughout the day can help prevent bloating after eating,” says Acharya.

There’s some science to back that up: One study found that a reduced-fiber diet helped relieve bloating in people with idiopathic constipation.

2. Limit the fat

High-fat foods help keep you full because they take longer to digest, but this slow process can delay emptying of the stomach and cause feelings of bloating.

You don’t “automatically have to avoid” higher-fat foods, says Houghton. “Rather, be aware of how your symptoms are affected by them. If you notice that you have an increase in cramping or gassiness (and it bothers you), then you may want to limit your intake of these foods.”

Container with artificial sweetener packets

3. Skip artificial sweeteners

Artificial sweeteners and sugar alcohols like sucralose, aspartame, saccharin, sorbitol, xylitol, and mannitol are known to cause bloating.

(Yes, even those in diet soda.)

“These ingredients, especially sorbitol, tend to be poorly digested and can cause symptoms similar to lactose intolerance when ingested,” says Houghton. “It is always a good idea to read your food labels and avoid these ingredients.”

4. Get some exercise

Don’t high-tail it to the couch after a big meal. Instead, look for a way to get in some simple movement or even a light workout.

One study found that exercising after a meal — like taking a walk or using a stationary bike — helped clear out gas and reduce bloating in participants.

5. Add enzymes to your diet

Digestive enzymes can ease bloating by helping break down substances that the body has difficulty digesting, says Acharya.

These supplements come in a variety of forms. One of the most popular is a-galactosidase, an enzyme sold over the counter as Beano.

Studies show that a-galactosidase significantly reduces bloating after eating fiber-rich meals.

6. Ask your doctor

Constant bloating can be a sign that something more serious is up. If nothing seems to alleviate your bloating — or you have other symptoms like severe pain, vomiting, diarrhea, or bleeding — then it’s a good idea to see your doctor.

Additionally, if you notice that you always feel bloated after particularly consuming a specific food item, it may be a sign of a food allergy or intolerance,” adds Acharya.

The COVID-19 Vaccine Priority Line Continues to Change as States Make Further Updates

This analysis updates the approaches states are taking to manage the limited initial supply of COVID-19 vaccines based on revised federal guidance and balance the desire to vaccinate those at greatest risk first with the need to ensure a fast and effective statewide vaccination effort. It includes a state data table.

Finally, an Encouraging Week in the Pandemic

Editor’s Note: The Atlantic is making vital coverage of the coronavirus available to all readers. Find the collection here.

In last week’s update, we wrote that the United States had reported the worst weekly case, hospitalization, and death numbers of the pandemic. At the time, it wasn’t clear what proportion of the case and death increases were related to postholiday reporting backlogs. This week brings some clarity: The backlogs appear to be largely behind us, and the underlying trends are moving in the right direction for most of the country. Even for the states experiencing the worst outbreaks, we are seeing early indications that the rates of cases, hospitalizations, and deaths are easing, though some areas are still reporting dangerously high case and hospitalization levels and wrenching death rates.

4 bar charts showing COVID-19 metrics week by week in the US. Tests rose 1% from last week, while cases, average hospitalized, and deaths all fell.

Weekly new cases for the seven-day period beginning Thursday, January 14 were down 20 percent, the lowest number of new cases we’ve seen for a non-holiday week since mid-November. As important, after 16 straight weeks of increases, average weekly hospitalizations dropped 4 percent this week—a modest improvement, but a good sign. Reported tests reached a new weekly high, edging out last week by 1 percent—though the high test numbers this week probably reflect the fact that the testing backlog is still catching up.

[Read: The most reliable pandemic number keeps getting worse]

States reported 21,301 deaths this week, the second-highest number of deaths of the pandemic to date. Yesterday, states reported 4,409 COVID-19 deaths, the highest single-day number of deaths on record. For comparison, in the week of September 24, 2020, states reported fewer than 5,000 deaths for the entire week.

Because of the way states report data for nursing homes, assisted-living facilities, and other long-term-care facilities, our figures for COVID-19 in these facilities refer to the week beginning January 8. These numbers remain very alarming: For the second week in a row, LTC facilities reported the highest death toll since we started gathering long-term-care data last May—more than 7,000 residents and staff. The number of known deaths reported this week may include backlogged figures from the winter holidays, and they also got a boost from a change in Iowa’s death reporting that increased that state’s reported figure.

Alt-Text: 3 weekly bar charts showing COVID-19 metrics in long-term-case facilities in the US over time. New cases are down about 15,000 from the week prior, though deaths are still rising.

There is also tentative good news from long-term-care facilities: The number of new cases was down by about 15,000 this week. It remains unclear whether case data have fully normalized from the reporting delays associated with the holidays, but next week’s data should confirm whether this case drop indicates a real improvement in the situation in long-term-care facilities.

Regional hospitalization and case data

A closer look at current COVID-19 hospitalizations offers good news for most U.S. regions. Hospitalizations remain very high but are declining modestly across the South and the West and continuing their substantial declines in the Midwest. In the Northeast, hospitalizations have plateaued.

Area charts showing currently hospitalized with COVID-19 over time in each census sub-region. While hospitalizations are still very high, especially in the South and West, most sub-regions are seeing declines begin.

At the state level, hospitalization data remain encouraging: Hospitalizations are declining or flat in every state but New York.

Area charts showing individuals currently hospitalized with COVID-19 over time in each census subregion. While hospitalizations are still very high, especially in the South and West, most subregions are seeing declines begin.

Cases, too, are falling in every region. In the Midwest’s “West North Central” division—which includes many of the states that had the worst per capita outbreaks late last fall—cases have very nearly returned to the levels reported at the beginning of October 2020.

Bar charts showing new COVID-19 cases over time in each census sub-region. No sub-region is currently at their peak for cases. In certain sub-regions in the Midwest, cases are close to Oct 1 levels.

A breakdown of weekly reported COVID-19 deaths by census regions and subregional divisions shows that although deaths are falling modestly across the country, they remain painfully high in most regions.

Bubble chart showing weekly deaths declining in all four Census regions and in all but two subregional divisions.

States we’re watching

Case and hospitalization declines are unquestionable good news. At the same time, in the country’s worst hot spots, states are still reporting very high numbers.

Arizona’s case count has fallen from last week, but per capita, the state’s case numbers remain the highest in the country at a seven-day average of 958 per million. The state is now nearly tied with South Carolina, where cases are rising rapidly. In Yuma County, Arizona, home to many of the state’s seasonal laborers, the Associated Press reports that the county has a positivity rate of 20 percent, compared with 14 percent for the state as a whole, and county public-health authorities said last week that they had run out of vaccines.

4 bar charts for COVID-19 metrics over time in Arizona, with 7-day average lines. Hospitalizations are at close to record levels in AZ, as are daily deaths.

Hospitalizations lag behind cases, and Arizona’s per capita hospitalizations remain by far the highest in the country. Arizona’s hospitals are under severe strain, with 92 percent of all ICU and inpatient beds occupied as of Wednesday, accompanied by a surge in pediatric COVID-19 hospitalizations. Nursing homes are also experiencing an increasing number of cases and deaths, and Fox 10 Phoenix reports that 40 percent of Arizona COVID-19 deaths have come from nursing facilities. Despite this, delays in the distribution of vaccines mean that many facilities (and patients) are still waiting for the first doses.

[Read: A vaccine for kids is coming, slowly]

The disparity in COVID-19 outcomes for Indigenous people in Arizona has been pronounced throughout the pandemic. At least one in nine people identified as “American Indians or Alaska Natives” has tested positive for COVID-19 in the state, while one in 16 white residents has. Indigenous people in Arizona are more than twice as likely to have been hospitalized with COVID-19 as their white neighbors, and more than 2.5 times as likely to have died.

Charts showing the cases, hospitalizations, and deaths per 100,00 in Arizona, broken down for racial and ethnic groups. All three outcomes are significantly more likely for American Indians or Alaska Natives than for other groups reported by the state.

California, which reported the third-highest number of new cases per capita this week, is finally seeing the number of new cases reported each day begin to decline. Even the state’s Southern California epicenter is seeing modest but important improvements: Following weeks of record-breaking cases and hospitalizations in Los Angeles County, the number of new cases per day is down 17.6 percent from two weeks ago, and hospitalizations are down 10 percent over that same time period, according to data from the Los Angeles Times. County officials warn that the virus is still surging in the area, and that hospitalizations remain at dangerously high levels, with ICU numbers remaining nearly unchanged over the past two weeks.

4 bar charts for COVID-19 metrics over time in California, with 7-day average lines. Hospitalizations are at close to record levels but cases have declined from a peak in early January

On Wednesday, the state surpassed 3 million total cases to date, meaning that one in 13 Californians has tested positive since the start of the pandemic.

As we’ve seen over the entire course of the pandemic, rising cases lead to rising deaths. The massive number of cases in Southern California over the past month has resulted in a wrenching death toll: The state reported 3,331 COVID-19 deaths in the past seven days alone. In Los Angeles County, air-quality rules limiting the number of cremations each day have been suspended to allow crematoriums to clear a backlog of bodies at hospitals and funeral homes.

In California, people identified as “Native Hawaiian and other Pacific Islander” are being disproportionately harmed by COVID-19. Although they make up a small part of the population, Native Hawaiians or other Pacific Islanders are three times as likely to have tested positive for COVID-19, and 1.8 times as likely to have died, as their white neighbors. Black people in California are 1.4 times as likely to have tested positive for, or died of, COVID-19 as white people in the state. Latino Californians, the largest single racial or ethnic group in the state, are 2.6 times as likely to have tested positive and 1.4 times as likely to have died as white residents.

Alabama, which had the second-highest number of COVID-19 hospitalizations per capita last week, has now reported its highest ever number of weekly COVID-19 deaths. In a gruesome echo of Southern California’s outbreak, Alabama crematoriums are running “around the clock to manage the increased demand. According to the CDC, Alabama also has the lowest COVID-19 vaccination rate of any state, although the Alabama Department of Public Health disputes the CDC’s numbers.

Four bar charts for COVID-19 metrics over time in Alabama, with seven-day average lines. Hospitalizations are at close to record levels. Deaths have shot up in recent weeks, especially over the past five days

The Black population of Alabama is being hit hardest by the state’s outbreak. Over the past two months, the number of cases per capita for Black people has increased more quickly than for other groups. For the 57 percent of Alabama cases where race is reported, Black people are more likely than anyone else in Alabama to have tested positive for COVID-19, and they are the most likely to have died.

[Read: The virus is showing Black people what they knew all along]

Adjusted for population, Nevada had the second-highest number of people in the hospital with COVID-19 this week. It also reported its highest ever single-day number of deaths on Wednesday, most of which were reported in Clark County, where Las Vegas is located. Originally intended to be lifted this week, the state’s COVID-19 restrictions have been re-extended until February 15. On January 15, the Las Vegas Review Journal reported that a total of 40 prisoners in the state had died due to COVID-19, a number that is more than four times higher than the state’s eight cumulative deaths among prisoners as of January 7.

4 bar charts for COVID-19 metrics over time in Nevada, with 7-day average lines. Hospitalizations are beginning to fall as cases have sharply declined in the past few weeks.

Throughout the pandemic, Latino people in Nevada have been more likely to experience COVID-19 than their white neighbors. One in nine Latino people has tested positive for COVID-19, compared with one in 15 white people in Nevada.

We are frequently asked for data on known variants of SARS-CoV-2, the virus that causes COVID-19. At present, very little data on the spread of variants exist in the United States, and we need much more genomic-sequencing data to understand the degree to which the virus is changing, and where variants are appearing. Unfortunately, the U.S. currently ranks 43rd in the world for percentage of cases sequenced. By contrast, the United Kingdom, where the widespread B.1.1.7 variant was first identified, is ranked eighth in the world. Earlier this month, the director of the U.S. Office of Advanced Molecular Detection at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases announced a plan to more than double the number of samples sequenced, from approximately 3,000 samples a day to about 6,500. The U.S. is currently reporting more than 200,000 new cases of COVID-19 each day. A state-run lab in Colorado was the first in the U.S. to identify a B.1.1.7-variant case this year and it is now routinely screening all samples submitted to the lab for this mutation. The Colorado Department of Public Health and Environment has also added variant case counts to their COVID-19 dashboards. To date, most states lack the resources to add genomic surveillance to their ongoing COVID-19 workload.

Premature Births: Causes, Treatment, Prevention, and Impact of COVID-19

Premature Births: Causes, Treatment, Prevention, and Impact of COVID-19

Premature birth is also known as preterm birth. It is defined as a baby born alive before reaching the gestational age (term to describe the length of pregnancy) of 37 weeks. The typical gestational period is usually 40 weeks which is considered a full-term pregnancy. Premature births occur in about 5-18% of all pregnancies and […]

The Doctor Weighs In

How a unique patient identifier gets health plans closer to interoperability

Health plans have been fighting against inaccurate member data, incomplete member profiles and duplicate records for years. Without a watertight way to keep track of patient identities so health data is reliably linked and accessible across multiple services, payers can’t always be confident that the record in front of them matches the member they have in mind.

The pandemic has brought this into sharp focus: positive COVID-19 test results aren’t always following members from service to service, and as the vaccination program rolls out, knowing who has had the disease and who has been vaccinated could be difficult to monitor.

As health data expands exponentially and the need to share and connect member records becomes more urgent and complicated, the challenges facing health plans will only grow. Could a unique patient identifier (UPI) be the answer?

4 member matching challenges that health plans could solve with a UPI

1. The healthcare ecosystem lacks 21st Century Cures Act data coordination

The lack of integrated systems to transfer member data securely contributes to safety issues, payment delays and potential audits and fines. Over a third of denied claims for health systems result from inaccurate patient information, costing them  at least $6 billion per year. While this would seem not to impact the payer, the inability to properly link claims to members could lead to an inability to understand the risk represented by the members being covered. Or worse, an inability to anticipate and monitor trends in members health and provide proactive healthcare options.

A unique patient identifier can connect the dots between different parts of the healthcare ecosystem so duplicate and incomplete member data can be detected and eliminated. With a more complete picture of who a member is, health plans can make decisions based on accurate information and exchange data safely and securely. There’s a far lower risk of acting without knowing about recent treatment or test results, or communicating using the wrong address (or even to the wrong member).

2. Healthcare providers have outgrown traditional matching tools

With the volume and variability of health data to be matched, traditional matching tools are no longer fit for purpose. For example, an enterprise master patient index (EMPI), which links all versions of a patient’s record across several facilities, may seem reliable. However, by relying on a single source of demographic data, EMPIs likely replicate errors and outdated information, and may combine records for patients who share certain demographic information (for example, if two patients have similar names and the same date of birth).

Instead, payers should consider a matching solution that combines member roster information with comprehensive third-party reference data. Member records are matched using referential and probabilistic matching, and connected using a UPI. This gives health plans a more complete picture of their members, built on reliable health, credit, and consumer data sources, and allows all parties to understand the person at the center of it all.

3. Discrepancies in member data make care coordination impossible

Members may use different names or nicknames, their address may change, and they may even share a Social Security Number (SSN) with someone else. How can health plans help to coordinate care if they’re not sure they’re tracking the right member?

A single electronic health record (EHR) can follow the member throughout their healthcare journey with a UPI, so health plans can be confident that the person on the phone or in the office matches the record on screen. They can monitor and respond to gaps in care, allowing them to better coordinate care for better patient health, improved member engagement and money-saving operational efficiencies.

4. Members present to multiple facilities, inhibiting care plan tracking

How can health plans reliably track medication adherence, especially when members present to multiple locations? Is there really a gap in care, or did the member just attend a different facility? And if members go to different pharmacies, how can a pharmacist be sure the prescription is going to the right person? All of this can create risks to patient safety and increased costs for payers.

A UPI can help. Experian Health has teamed up with the National Council for Prescription Drug Programs (NCPDP), which sets standards for pharmacy services to exchange electronic healthcare data. A framework has been built for a UPI-based patient matching solution that the entire US healthcare network can use. Not only will this improve patient safety, it’ll minimize staff time spent on reconciling incorrect records, thus boosting financial performance too.

When it comes to mismatched records, prevention is better than cure. With a Universal Identity Manager, health plans can have confidence in the accuracy and security of the data they’re using and sharing, promote patient safety, and improve staff productivity.

Contact us to learn more.

The post How a unique patient identifier gets health plans closer to interoperability appeared first on Healthcare Blog.

How AI is reshaping the future of the patient-provider experience

We’re only just beginning to learn how to harness the power of AI in ways that cultivate stronger healthcare systems — and ensure that the value of connection akin to the human condition is not lost but rather nurtured in its use among healthcare providers.

KHN’s ‘What the Health?’: The Biden Health Agenda

Can’t see the audio player? Click here to listen on SoundCloud.

President Joe Biden wasted no time getting down to work. Among the raft of executive orders he signed on Inauguration Day were several aimed at curtailing the covid crisis, including one requiring mask-wearing by federal employees and anyone on federal property for the next 100 days.

Meanwhile, with the inauguration of Vice President Kamala Harris and the swearing-in of two new Democratic senators from Georgia, Democrats took over the majority in the Senate, albeit with a 50-50 tie. That leaves Democrats in charge of both the legislative and executive branches for the first time since 2010, but with such narrow majorities it could be difficult to advance many of Biden’s top health agenda items, starting with an expansion of the Affordable Care Act.

This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Tami Luhby of CNN and Sarah Karlin-Smith of the Pink Sheet.

Among the takeaways from this week’s podcast:

  • Although Biden can make certain changes to the federal policies in the fight against covid-19, much of what he has detailed in his plan will require congressional action, and Senate Republicans do not appear willing to support a major legislative package just yet.
  • Many of the efforts against covid that Biden has said he wants to put in place are initiatives that have been recommended by public health officials over the past year and not acted upon. But the discovery of new, more contagious variants of the coronavirus may necessitate faster efforts to distribute vaccine and other actions.
  • Wearing masks and other simple public health practices can have a big impact on slowing the spread of covid, but much of the public is looking to a vaccine for help. Those supplies remain limited and it’s not clear whether Biden’s interest in using the Defense Production Act to force industry to help will increase vaccine production.
  • Vaccination success is hampered by unreliable estimates of the amount of supplies states can expect to receive and a patchwork of sign-up methods and eligibility criteria.
  • Among the actions Biden and a Democratic Congress could take to reverse policies instituted by the Trump administration are ramping up workplace enforcement of covid rules to help keep employees from spreading the disease, restoring a penalty for not having insurance so that the lawsuit threatening the Affordable Care Act would become moot, and overturning rules requiring reviews of federal scientists.
  • The Senate has not yet scheduled a confirmation hearing for Xavier Becerra, Biden’s choice for Health and Human Services secretary. Before a mob stormed the U.S. Capitol this month, it was thought that establishing a new federal health team would be the president’s priority, but national security took precedence after the violence.
  • Controlling drug prices is an issue with huge popular support, but Congress is divided over how to do it. The broad measure that passed the House in 2019 is again unlikely to fly in the Senate, but senators may try to produce a more modest proposal along the lines of a bipartisan measure offered previously by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore).
  • Drugmakers have generally fought most efforts to implement price controls, but there may be growing interest within the industry to work out a bipartisan deal that they have a hand in, rather than waiting to see what Democrats can push through.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: The Atlantic’s “Pramila Jayapal Is ‘Next-Level’ Angry,” by Elaine Godfrey

Alice Miranda Ollstein: The New York Times’ “Emerging Coronavirus Variants May Pose Challenges to Vaccines,” by Apoorva Mandavilli

Sarah Karlin-Smith: Vanity Fair’s “A Tsunami of Randoms”: How Trump’s COVID Chaos Drowned the FDA in Junk Science,” by Katherine Eban

Tami Luhby: KHN’s “Black Americans Are Getting Vaccinated at Lower Rates Than White Americans,” by Hannah Recht and Lauren Weber

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify, or Pocket Casts.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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mRNA Vaccines: What Happens

A question that comes up a lot about mRNA vaccines is what happens at the cellular level after you’re injected with one. The mechanism of any such vaccine is to cause cells to produce a viral protein antigen, but which cells actually do this? It’s also understood that mRNA vaccines tend to act as their own adjuvant and stimulate a further immune response that improves their efficacy – but how does that happen as well?

Let’s dive into some details. But while doing so, I need to note up front that not all of these details are completely known, immunology being what it is. Still, over 25 years of work on the idea of mRNA vaccines have provided a lot of information, which (never forget!) is the only reason that the current vaccines could be developed so quickly. If you remember Tina Turner’s 1986 song “Overnight Sensation”, you’ll have the right idea: after years (decades) of hard work, false starts, and expensive lessons learned, mRNA vaccines for infectious disease were finally ready to come out of nowhere. I’ve linked to this review before (open access), but it’ll give you an idea of how long all this has been in the works.

One thing to note is that such vaccines can have rather different effects if administered through different routes. Here’s a mouse study in 2015 from researchers at Penn and Acuitas (the Vancouver lipid company that’s now partnered with Pfizer and BioNTech for their vaccine), looking at lipid nanoparticle mRNA injected several different ways (intradermally, intraperitoneally, subcutaneously, intramuscularly, and intravenously). They just used the RNA for firefly luciferase as a marker for convenience, because you can inject the mice later on with luciferin (the partner for the enzyme) and just look to see where they light up. For those of you outside the biomedical sciences, I am speaking completely literally.

What they found was that the mRNA injected i.p or i.v. went straight down to the liver, which is not a surprise. You might remember Alnylam, the company developing siRNA therapies – their big success has been targeting rare disorders in the liver, because they’re well aware that that’s where most of their RNA constructs are going to park, anyway. In this mouse model, the mRNA hit the hepatocytes and caused them to make plenty of luciferase, but not for long: at Day 1, the livers were lit up like a used car lot, but by Day 3, everything was gone. At that point, though, there was still some light coming from the sites of injection.

And that’s what you see with the intramuscular dose as well: a good part of the dose goes to the liver, but in that case there’s a substantial effect in the muscle tissue itself, and it’s longer-lasting (out to about a week of protein expression). The subcutaneous and intradermal injections, though, didn’t really show up in the liver at all: the sites of injection light up and keep on going, again, for about a week. This paper didn’t note it, but you would also expect all three of these injections to have some drainage into the lymphatic system as well, which is also important for setting off the immune system. Here’s a 2017 paper from CureVac and Acuitas that demonstrates this in monkeys, though, in the context of experimental vaccines for influenza and for rabies – they could see activation of the innate immune system at the injection site after an intramuscular dose and at the corresponding draining lymph nodes. That’s an important effect with vaccines in general, as you’d imagine, since that’s one of the big sites for antibody maturation and B-cell selection, as mentioned in the last post here. This 2017 paper from the Karolinska Institute, working with GSK, demonstrates this with GSK’s well-known vaccine adjuvant.

And here’s a 2017 paper from the same team at Karolinska along with Moderna, looking at LNP-mRNA influenza vaccines in a primate model as well. They didn’t even bother with intravenous dosing by this point – it’s a comparison between intramuscular and intradermal. It looks like the intradermal dose comes on more quickly in antibody production, but in the end, the two are pretty similar. The paper goes into detail on the rise in the number of germinal centers in the draining lymph nodes, the exact location of all that B-cell selection and the corresponding antibody changes, which argues strongly that the antibody improvements mentioned in yesterday’s post will occur after mRNA vaccination as well. Another 2017 paper from Moderna has more influenza mRNA vaccine data in several animal models, with consistent results – these were the studies leading up to their human trials in this area. In this case, you see protein production at the injection site, in the downstream lymph nodes, and (coming in third), in the spleen (also good news from the immunologic view), and then the liver. All other tissues were much further down the list.

The total amount of protein produced was also estimated in the 2015 paper, and it turns out that the i.v. route actually makes a bit more than the others, shorter duration and all. But overall, you’re almost certainly better going intramuscular – it still has good protein production, and the multiday duration and lymph node involvement are both good for the immune response you’re trying to induce.

Both the Pfizer/BioNTech and Moderna vaccines are being given i.m., so if you’d like to know what parts of your body are producing the coronavirus Spike protein antigen, the answer seems to be the muscle tissue at the site of injection, the lymphatic tissue downstream in your armpit on that side, your spleen, and (for the first day or two) your liver. The bulk of the Spike that you’re going to make is probably made in the first two or three days, anyway, from what we can see from the animal models. My wife was just saying that it’s too bad that we don’t have a luciferase-style readout built in for us humans as well – she’s enthusiastic about being able to watch a green glow coming from under her skin to know that the vaccine is doing its job, but freely admits that this would probably set off a lot of lunatic conspiracy theories as well.

Let me finish off with another paean to experimentation. If you’ve had a chance to look at those papers referenced along the way, you’ll see that many of them make comparisons to other vaccine technologies. This 2018 one from Penn, Duke, Acuitas and others is especially clear on that point. What you can see is that it was already becoming apparent that the mRNA platform had great promise for inducing strong, wide-ranging immune responses – stronger, in fact, than many comparator techniques. The work that had been done over the years on formulations, RNA modifications and other techniques was paying off just in time for the current pandemic. mRNA vaccination was in exactly the right stage for things to take off with a good expectation of success.

It wasn’t always that way. I mentioned the innate immune system before, and without getting too far into the weeds, it has to be noted that getting the balance right between that innate response and the adaptive response is a key for any vaccine technology. You’d like to have the innate system in play, but if you set it off too strongly with either an mRNA or viral vector vaccine, you can actually damage your total antigen production (and the subsequent adaptive antibody response) due to attacks on the vaccine species themselves.

It is not totally obvious how you strike that balance, though: the innate immune system works through a whole army of receptors – a long list of toll-like receptors (TLRs), RIG-I and the other pattern-recognition receptors and proteins, such as MDA5, LGP2 and more. This is all an elaborate sentry system that is watching for weirdo DNA and RNA species as a sign of viral infection, and is ready to bat them down through a whole list of counterattacks. So to get a good RNA vaccine, you frankly have to make it work like a particularly stealthy virus, and not trip every single alarm before your payload gets a chance to enter the cells. But as mentioned, some activation of the innate system is needed to get the adjuvant boost. A lot of that work has to be done empirically, which is why we’ve seen so many RNA and DNA formulation ideas over the years. None of these have been stupid ideas (far from it) but some of them work better than others, and the current lipid nanoparticle ones are the current state of the art – the LNPs themselves activate the innate immune system, but in a way that doesn’t seem to trigger too much of a self-defeating cytokine response. It’s a useful enough effect that they’re being proposed as adjuvant additions to other, more traditional vaccines for that effect alone. This effect had to be discovered by hard work and repeated testing; you’re not going to whiteboard your way past mammalian immunology, not for a long time yet. . .

Update: if you’d like to know more about the supply chain for the lipids and RNA in making these vaccines, here is an excellent place to find out the details.

Gene Therapy Comparability

The inaugural Gene Therapy Comparability Summit is the only industry dedicated meeting to ensuring your manufacturing processes are effective and comparable at every stage of development, supporting a seamless transition to the larger scales required for commercialization.

This meeting will unite large pharma and innovative biotechs including Pfizer, Biogen, BioMarin and Takeda as they share best practices, lessons learned and analytical data across the comparability lifecycle.

Focused specifically on enhancing your gene therapy comparability approach, join us to ensure you maintain safety, quality, consistency and efficacy throughout scale-up from clinical to commercial-scale manufacturing, and satisfy regulatory demands to avoid costly delays to clinical programs.

Incorporating insights from leading CMC, Regulatory, Analytical and Process Development experts, this is your opportunity to gain extensive technical information on challenges like ensuring manufacturing processes are comparable when changing facilities and cell lines, developing effective bioassays for use in comparability studies and handling the limited gene therapy lots available.

View the full event guide here to see the full agenda, speaker faculty and more!

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Orange Book Preface

Preface to Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) provides info on how the book came to be, relevant terms and codes, user responsibilities and more.

Testing Lab Data Reveals Spread of New Covid Variant Across the Country

Scientists at the Alderley Park Lighthouse Lab in Cheshire have revealed the speed and scale at which the new variant of the COVID virus is spreading through communities across the country.

The Lighthouse, operated by Medicines Discovery Catapult (MDC) and launched last April, plays a key role in the UK Government’s national COVID testing programme. It can process more than 50,000 samples a day and has recently completed its 6 millionth test.

Its scientists have identified the new COVID variant in the lab’s PCR test and have been able to use this new science to track the spread of the new COVID variant across England and Wales.

The ThermoFisher PCR test, used at many of the Lighthouse Lab sites, measures 3 genetic markers of SARS-CoV-2.  Lighthouse scientists have shown that the new variant exhibits ‘S-gene dropout’, whereby one of the markers – the S-gene – fails to amplify, but the other two genetic markers (ORF1ab and N) are found, confirming a positive COVID result.

Working with ThermoFisher, the Wellcome Sanger Institute and PHE teams, the Lighthouse Lab network first noted data trends in November.

The Lighthouse data shows the rise and geographical distribution of these S-gene target dropout cases from the 1st to the 21st of December 2020. The data shows rapidly increasing numbers of cases of the new variant across London, East-South East, parts of the North West, South West regions and West Midlands.

Areas with the highest incidence in the study correlate with areas now reporting high NHS load and hospitalisation. This dramatic timeline view validates the national level of concern, concurrent with the imposition of the recent lockdown. Ongoing vigilance of the data may also indicate regions that in future will see high infection and hospitalisation rates.

Professor Chris Molloy, CEO of MDC and founding director of the Lighthouse Lab network believes it demonstrates the quality of the science that underpins what is the largest diagnostics project in UK history.

Prof. Chris Molloy, said:

“Today’s high-quality data from the MDC Lighthouse team shows the excellence of its science at a national scale.  The Lighthouses are high-powered beacons into the darkness of this disease, combining industrial scientific rigour and close coordination with NHS and PHE in the service of the nation.”

Dr Mark Wigglesworth, Site Director at the Alderley Park Lighthouse Lab and senior author of the report, comments:

“Although the speed of the spread is shocking, we’re working really closely with the government to share our scientific discoveries and advancements, which in-turn informs decision making across the devolved nations, so that we can be in the best position to beat the virus.

“While a new national lockdown is not what anyone would have wanted, our scientists’ work in discovering the spread of the new variant will be pivotal in informing government policy, protecting the NHS and saving lives.”

For more information on the findings, read the paper at medRxiv >

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Gene Therapy for Muscular Disorders

With clinical holds lifting there has been more investment and clinical progress in the gene therapy for muscular disorders space than ever before, yet the consequences of toxicity are not a distant memory. Despite the successes, there are still withstanding challenges for gene therapy developers targeting the muscle when it comes to optimizing delivery and navigating toxicity to develop truly safe and transformative therapeutics for muscular disorders patients.

The first industry-dedicated Gene Therapy for Muscular Disorders Summit will focus on overcoming the translational and clinical challenges of developing genetic therapies targeting muscular disorders, including Duchenne Muscular Dystrophy (DMD), Limb-Girdle Muscular Dystrophy (LGMD), Pompe Disease and X-Linked Myotubular Myopathy.

Join your fellow industry leaders from the likes of PTC Therapeutics, Solid Biosciences, Pfizer, AskBio Novartis at this digital event in March.

View the event guide here for the full meeting details!

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Telemedicine Expands Access to Healthcare in Rural Areas

In March 2020, Dr. David Rich planned to use some vacation time to tackle a few projects around the house, but he didn’t get far. Midway through the month, with the coronavirus spreading rapidly throughout the U.S., the federal government declared a national emergency. Within a week, organizations across industries were closing their doors.
“We realized we needed to come up with alternatives,” says Dr. David Rich, chief medical information officer at West Virginia University Health System.
WVU Medicine had a fledgling direct-to-consumer telehealth program offering services to employees and…

Bio Integrates 2021 (Digital)

Making new connections is vital to helping the biotech industry continue their journey. Bio Integrates creates these opportunities and provides attendees with significant opportunities to learn from and interact with our growing community, to enhance both current and future needs.

Our debate-led format provides our attendees with the opportunity to hear from and ask questions of those that have succeeded in their respective fields, whilst our face-to-face networking platform enables a replication of the chance encounters you experience at live events. Add to this opening address and fireside chats with key industry figureheads, and new for this year our ‘C-Suite Series’ from thought leaders, you can see why Bio Integrates is an event unlike others.

WHO ATTENDS BIO INTEGRATES?

From a standing start in 2019, Bio Integrates is now in its third year and attracts over 400 senior executive attendees from:

  • Biotech Organisations
  • Pharma Organisations
  • CDMOs & CROs
  • Investors
  • Regulators
  • Supply chain solution providers
  • Patient Groups

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ONC Names Micky Tripathi New National Coordinator for Health IT

ONC Names Micky Tripathi New National Coordinator for Health IT
Micky Tripathi, ONC National Coordinator for Health IT

– The ONC
has named Micky
Tripathi as the new National Coordinator for Health IT under President Joe
Biden’s administration, succeeding Don Rucker, M.D. who held the post since
April 2017.

– The
Office of the National Coordinator for Health Information Technology is the
principal entity charged with coordination of nationwide efforts to implement
and use the most advanced health information technology and electronic exchange
of health information. As National Coordinator, Tripathi will be at the
forefront of the new administration’s health IT efforts, the
adoption of health information technology, and the promotion of a nationwide
health information exchange to improve healthcare.

– Tripathi
most recently served as Chief Alliance Officer of Boston-based Arcadia, where he was responsible for developing
strategic partnerships between Arcadia and other innovative companies
to further accelerate the use of advanced technology to improve healthcare.

– Prior to
Arcadia, Tripathi had been the President and Chief Executive Officer of the
Massachusetts eHealth Collaborative (MAeHC), a non-profit health IT advisory
and clinical data analytics company. 
MAeHC was formed in 2005 to improve the quality, safety, and
cost-effectiveness of healthcare, focusing on the use of healthcare technology
to make critical patient medical information available immediately at the point
of care.

Cerner Appoints Mark Erceg New Chief Financial Officer

Cerner Appoints Mark Erceg New Chief Financial Officer
Mark Erceg, CFO at Cerner

Key Points to Know:

Cerner appoints Mark Erceg as the company’s
new Executive Vice President and Chief Financial Officer (CFO), effective
February 22, 2021.

– Erceg will succeed Marc
Naughton, who is departing from Cerner at the end of the first quarter.
Naughton will serve as an Executive Advisor to ensure a smooth transition.

– As Cerner’s CFO, Erceg
will lead the company’s global finance organization, including accounting,
treasury, financial planning and analysis, tax and investor relations.

– Erceg comes to Cerner with
more than 25 years of multi-dimensional financial experience, including serving
as CFO at three different publicly-held companies. He began his career at
Procter & Gamble and spent more than 18 years in a variety of finance,
strategy and operational leadership roles. After leaving P&G, Erceg had
three successive CFO roles at Masonite International Corporation, Canadian
Pacific Railway and Tiffany & Company, where he has developed deep
functional expertise and technical knowledge in all aspects of corporate
finance.

NICE backs broad use for Gilead/Galapagos arthritis pill Jyseleca

Patients with rheumatoid arthritis (RA) in England will be able to get treatment with Gilead Sciences and Galapagos’ JAK inhibitor Jyseleca, after it was backed by cost-effectiveness agency NICE.

Jyseleca (filgotinib) has been recommended for moderate and severe active RA in patients who have responded inadequately to intensive therapy with two or more conventional disease-modifying antirheumatic drugs (DMARDs) such as methotrexate or hydroxychloroquine.

It can be prescribed in combination with methotrexate or as a monotherapy if the patient isn’t able to receive methotrexate, according to the final appraisal document (FAD).

Other JAK inhibitors have already been cleared by NICE for RA – including Pfizer’s class-leading Xeljanz (tofacitinib), Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib) – but can be used in patients with severe symptoms only.

Having moderate disease on the label means that thousands more patients will be eligible for treatment with Jyseleca, according to Gilead and Galapagos. They note that more than 400,000 people across the UK live with RA, and around 70% have moderate or severe disease.

“This is a landmark decision from NICE and represents a pivotal moment for the treatment of RA,” said Dr James Galloway, consultant rheumatologist at King’s College Hospital.

“The goals of treatment in this condition are to control pain, prevent disability and improve quality of life. This requires us to act quickly to control the disease, preventing irreversible joint damage as soon as possible, for as long as possible,” he added.

“While no single medicine works for everyone, the addition of filgotinib is an important step forward that we believe will help more patients achieve remission, even when their disease is at a less advanced stage.”

Rinvoq is currently being appraised by NICE for use in moderate RA, but a timeframe for that review hasn’t been revealed.

The recommendation is a boost for Jyseleca, which is sold in Europe and Japan but suffered a big setback last year when the FDA rejected the drug over concerns that it could damage male fertility, saying it wanted further data from ongoing studies before completing its review.

Last month, Gilead said it would no longer pursue approval of the drug in the US after an FDA meeting to discuss the way forward revealed the agency is unwilling to approve the higher 200mg daily dose of the drug.

Gilead – feeling that the 100mg dose only wouldn’t be competitive with Jyseleca’s rivals – opted to pare down its involvement in the product dramatically.

It abandoned plans to pursue US registration for RA, and handed responsibility for Jyseleca in Europe to Galapagos, agreeing to pay its partner €160 million (around $194 million) to fund further development and the formation of a commercial operation for the drug which is due to come into full force at the end of this year.

Gilead will receive royalties on European sales from 2024, and retains commercial rights elsewhere.

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The Coverage Gap: Uninsured Poor Adults in States that Do Not Expand Medicaid

In states that do not implement the Medicaid expansion under the Affordable Care Act (ACA), many adults will fall into a “coverage gap” of earning too much to qualify for Medicaid but not enough to qualify for Marketplace premium tax credits. Nationwide, 2.2 million poor uninsured adults are in this situation. This brief presents estimates of the number of people in non-expansion states who could have been reached by Medicaid but instead fall into the coverage gap and discusses the implications of them being left out of ACA coverage expansions.

UK agency Aurora promotes Chris Bath to managing director

Independent UK comms agency Aurora has promoted Chris Bath to managing director.

In a statement the London-based agency said Bath joined in 2015 and achieved rapid promotion to the agency’s management team.

As well as providing senior counsel to clients and agency teams, he led the development of the agency’s digital insights capability and recently launched its measurement practice, Acumen, which helps clients prove the impact of their communications.

Aurora was founded in 2005 by Claire Eldridge and Neil Crump and has recently launched a sister consultancy, Atlas.

This supports clients to connect with patients and advance products and services through strategy, co-design and organisational change services.

Despite the pandemic, Aurora said it has been able to continue to hire and promote, to build its team of 28 communications experts.

Aurora is the sole UK agency and European hub for GLOBALHealthPR, the largest independent health and science communications agency partnership worldwide.

CEO Claire Eldridge said: “Chris is the ideal person to lead this charge, both from a cultural and capability perspective.

“He provides excellent counsel, champions evaluation, and lives our company values every day. In doing so, he enables our healthcare clients to communicate effectively and so achieve better patient outcomes – which is what Aurora is all about.”

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Challenges of Operationalizing Remote Patient Monitoring Data

Challenges of Operationalizing Remote Patient Monitoring Data
Roberto Martinez, President, Mexico, Encora

Among the many evolving technologies in the healthcare industry, there may be none more important or impactful than remote patient monitoring (RPM) hardware and software solutions. This technology is opening up new possibilities in extended healthcare – saving patients money, limiting visits to the doctor’s office, and providing healthcare professionals with powerful tools for diagnosing and treating patients. As these tools continue to mature, software and hardware developers are solving critical challenges to enhance their capabilities and impact.

According to a 2019 report published by the Consumer Technology Association, 88% of healthcare providers have invested in, or are evaluating investments in, RPM technologies and services. Increased demand is driven primarily by the rising age of the baby boomer generation and an increase in chronic disease among the American population.

Medical device manufacturers are helping healthcare providers gather data on patients everywhere they go using wearable technology. These connected health monitoring devices come in the form of smartwatches, wearable heart monitors, blood pressure kits, and more. They’re developed with mobile communication technology that sends data using a patient’s smartphone or directly from the wearable device to software platforms that make the information available to healthcare providers and first responders, notifying them in real-time of accidents and/or healthcare concerns. 

The need to monitor patients outside of a clinical setting, especially during the pandemic, has become extremely important and demanding. We’re witnessing limited capacity in hospitals, significant challenges related to social distancing and other pandemic-related stressors. RPM technology can be a tremendous help in mitigating these issues. 

Despite significant advancements in the art of the possible, RPM is still in its infancy in terms of the potential impact it could have on health and safety. Data security, data accuracy, and systems integration are core challenges that developers of the next generation of innovative RPM devices need to address. This includes overcoming technological and regulatory barriers preventing patient data from being received, making use of machine learning algorithms, and combining real-time data with medical histories. 

Developers of RPM devices must also move beyond model-building and into operationalization for the real potential of technology to be realized and create value for healthcare professionals. Specifically, abstract concepts need to be turned into measurable observations. In its blog “Operationalization of Machine Learning Models,” Open Data Science opines, “Data scientists create beautiful models that no one can understand, and the models don’t usually translate to real business value. If a process is isolated from the enterprise, the insights won’t feed into the overall process.”

To make significant advancements in RPM innovation, software developers must build a digital framework that includes:

– Data storage

– Security

– Middleware

– Machine learning and artificial intelligence

– User interface and user experience 

It begins with a data storage framework that organizes legacy data and real-time data in the cloud and feeds it into the algorithm. Volumes of data can be huge and the types of data can be various, yet they need to be monitored and managed by a single system. 

The next layer of the framework is data security. The challenge is developing a security framework that keeps data confidential for unauthorized users. At the same time, patients must be allowed to establish clear boundaries of ownership over the data, whether that access is given to family members or primary care providers. In the case of an emergency where the patient is incapacitated and unresponsive – the authorized user must be able to quickly access the data to treat the patient.

Next is the middleware, which is software that provides common services and capabilities to applications outside of what’s offered by the operating system. The middleware is customized to meet the needs of the user, in this case, the healthcare provider. 

All of the organized and secure data is then funneled into AI and ML algorithms which will learn and recognize patterns derived from a wide range of data points. There needs to be a high level of trust in the data derived from RPM devices. This is achieved through the collection and proper management of data from large and diverse demographic groups. For example, if AI and ML algorithms are fed significant amounts of data from African American females between the age of 50-65, the algorithm can begin to recognize patterns that lead to more informed diagnoses and patient care plans.

The final piece of framework is the user interface and user experience. One of the most significant challenges to developing a healthcare platform for RPM devices is engineering how the data is presented to a healthcare provider. These professionals don’t have time to learn how to decipher data points on a screen –designers and engineers need to create a user interface that translates patterns in the algorithm into valuable and easy to read information that can improve patient outcomes. 

When it all comes together, the results are rewarding. Let’s take a look at one of the most promising examples of RPM in the real world today. Lark Health, a chronic disease prevention and management company that uses a cognitive behavioral therapy framework, conversational A.I., and connected devices to help people stay healthy and in control of their conditions. Lark’s A.I. is continuously learning how to personalize the experience for the member and communicates via text-message-like interactions to monitor patients remotely, 24/7, while live nurses and health coaches are available when issues need to be escalated such as severe readings or medication changes.

The challenge of getting the most out of RPM technology is not an easy one. It takes high-level expertise in design, software engineering, and data science, as well as knowledge of AI and ML algorithms to learn how to operationalize it. But with the right framework and data, RPM will continue to revolutionize the healthcare industry.


Roberto Martinez, president, Encora, MexicoRoberto Martinez has been working in the software nearshoring industry for 20+ years. As a senior executive, he is familiar with the needs, obstacles, and challenges faced by small startups as well as big teams. As a leader at Encora, Roberto has helped the company acquire important clients such as OpenTable, Siemens, ZED Connect (Cummins), and others. Roberto has a software engineering background from the prestigious Tecnologico de Monterrey and strategic direction from IPADE.


Mobile labs take vaccine studies to diverse neighborhoods

New vaccine studies must include communities of color that have been hard-hit by the pandemic. To help, researchers in more than a dozen spots around the country are rolling out mobile health clinics to better reach minority participants and people in rural areas who might not otherwise volunteer.

Russia asks for “non-political” treatment of Sputnik V shot, then rules out US filing

The state-owned backers of Russia’s Sputnik V coronavirus vaccine have ruled out a US filing, as talks began in earnest with European regulators over a review.

Following a press conference on Thursday morning, the Russian Direct Investment Fund (RDIF), which has been bankrolling the vaccine developed by a team in Moscow, said it had already had enough orders for the vaccine.

RDIF, which is Russia’s sovereign wealth fund, said that with 2.4 billion doses already ordered worldwide, enough for 1.2 billion people, there is no interest in supplying a US market of 328 million people.

“Why should we?” said an RDIF spokesperson when pharmaphorum asked if there were plans to file the vaccine developed by the Gamaleya Research Institute with the FDA.

Supplies of the vaccine are due to begin shipment to Hungary, where the national regulator has independently approved it in a move that has caused tension with the rest of the EU.

The spokesperson’s comments came after CEO Kirill Dmitriev focused on the importance of keeping politics out of  the vaccine approval process in today’s briefing.

A major peer-reviewed study of the vaccine is due for publication next week, Dmitriev said, who made the case for the vaccine’s safety, efficacy and easy storage and transport requirements.

Praising regulators that had approved the vaccine so far, such as Hungary and the United Arab Emirates, Dmitriev said: “A non-political approach will save the world. We believe it will be one of the most widely accepted vaccines in the world.”

He also referred to press reports from Israel raising concerns about the efficacy of the initial Pfizer vaccine shot, while claiming that Sputnik V can produce 73% efficacy after its first dose.

To get the shot approved across Europe RDIF must get Sputnik V centrally authorised by the European Medicines Agency (EMA), following guidance announced earlier in the pandemic.

There have already been preliminary “Scientific Advice” talks with the EMA ahead of a potential rolling review beginning next month, although the RDIF gave no further guidance on timelines.

The RDIF is to receive support from the German regulator to get the vaccine reviewed by the EMA, the spokesperson.

Chancellor Angela Merkel said today that Germany’s regulator the Paul Ehrlich Institute, can provide assistance in the process.

The first shot to win the backing of a national regulator last summer, Sputnik V only needs to be stored at conventional refrigerator temperatures instead of the ultra-cool temperatures required to maintain the integrity of delicate mNRA vaccines from Pfizer/BioNTech and Moderna.

Study data so far suggest that at 90% effectiveness it provides protection that is almost on par with the mRNA vaccines, while AstraZeneca’s rival is only 62% effective in its approved formulation.

RDIF was established in 2011 by the Russian government to make investments in leading companies and high-growth sectors of the country’s economy, looking for co-investment from large institutional investors.

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Vaccine hesitancy 39 per cent in Delhi-NCR: Survey

The findings of the fourth round of the Delhi-NCR Coronavirus Telephone Survey (DCVTS-4) conducted by the economic think-tank NCAER showed that about 20 per cent respondents were certain about not taking the vaccine. Of this, 22.4 per cent were from rural areas and 17.5 per cent from urban locations.

NCTR Annual Reports

NCTR Annual Reports (Research Accomplishments and Plans) including the 2015-2016, 2016-2017, and 2018 and 2019 Annual Reports in PDF format. This report summarizes the key accomplishments for each Research Division for the fiscal year as well as the Division’s plans for the upcoming fiscal year.

Prescient Healthcare Group to Partner with Bridgepoint Development Capital

The partnership will further enhance the depth, breadth and value of services for Prescient’s pharmaceutical and biotech clients.

LONDON, January 21, 2021: Prescient Healthcare Group (Prescient), a global product strategy advisory firm serving the pharmaceutical and biotech industries, announced today that Bridgepoint Development Capital, part of Bridgepoint, the international alternative asset management group, has agreed to invest in the business for an undisclosed sum, replacing current investor Baird Capital as the majority shareholder.

Founded in 2007, Prescient is headquartered in London and has offices in the US, India and China. The business provides product strategy services to help its clients make better clinical and commercial decisions, resulting in enhanced outcomes for patients. Prescient works with many of the leading multinational pharmaceutical companies, as well as a growing number of emerging biotech and specialty pharmaceutical organizations. Prescient has formed a partnership with Bridgepoint to support the continued scaling of its talent platform, client value proposition and global infrastructure.

“We are thrilled to be partnering with Bridgepoint, which has an impressive track record supporting the scaling of people-based businesses. Bridgepoint buys into our mission of becoming the biopharma strategy partner most respected for its people, expertise and impact,” said Jamie Denison-Pender, Prescient CEO. “I’m excited by the collaborative approach and hunger for excellence that Bridgepoint will bring to the boardroom and much look forward to our partnership as we continue to invest in our passion for helping our amazing clients develop and commercialize innovative treatments that bring such hope and relief to patients globally.”

“We’re delighted to partner with Prescient to help it drive growth and consolidate its market leadership and share management’s ambitions for the expansion of the Prescient platform. This will be achieved through a combination of investment to enhance scale and expertise, organic growth and selective M&A, with the aim of becoming the leading technology- and data-enabled strategic product partner of choice for decision support and advisory services to the large pharma industry,” said Stephen Bonnard, partner at Bridgepoint Development Capital.

Dr. Nick Edwards will remain Prescient’s Chairman. Baird Capital will be reinvesting in the company as a minority shareholder alongside Bridgepoint.

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Insights+: The US FDA New Drug Approvals in December 2020

The US FDA has approved 7 NDAs and 2 BLA in Nov 2020, leading to treatments for patients and advances in the health care industry.  

The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 105 novel products so far in 2020, including 9 in Dec 2020.  

Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 9 new drugs approved by the US FDA in Dec 2020. 

The US FDA Approved Gallium 68 PSMA-11 as the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer 

Published: Dec 01, 2020 | Tags: US, FDA, Approves, Gallium 68 PSMA-11, PET imaging, PSMA Positive Lesions, Men, Prostate Cancer 

  • The approval is based on two prospective studies assessing Ga 68 PSMA-11 in 960 men with prostate cancer. The first trial enrolled 325 patients & the second trial enrolled 635 patients with biopsy-proven prostate cancer who underwent PET/CT or PET/MRI scans and who had rising serum PSA levels after initial prostate surgery or radiotherapy  
  • 74% of patients had at least one positive lesion detected by Ga 68 PSMA-11 PET in at least one body region  
  • Ga 68 PSMA-11 is a radioactive diagnostic agent that is administered in the form of an IV injection. The approval is granted to the University of California  

Vanda’s Hetlioz (tasimelteon) Received the US FDA’s Approval for Nighttime Sleep Disturbances in Smith-Magenis Syndrome  

Published: Dec 01, 2020 | Tags: Vanda, Hetlioz, tasimelteon, US, FDA, Approval, Treatment, Nighttime Sleep Disturbances, Smith-Magenis Syndrome 

  • The approval is based on study assessing Heltioz vs PBO in both adults with SMS taking the capsule formulation and children with SMS taking the liquid formulation. The safety profile of the therapy is in consistent with previous study conducted for the treatment of Non-24-Hour Sleep-Wake Disorder 
  • Hetlioz capsules will available imminently for adults and Hetlioz LQ liquid formulation for children is expected to be available in Q1’21  
  • Hetlioz is melatonin receptor agonist & is an approved therapy in the US & EU 

Roche’s Gavreto (pralsetinib) Received the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers 

Published: Dec 02, 2020 | Tags:  Roche’s, Gavreto, (pralsetinib), Receives, US FDA’s Approval, Advanced or Metastatic RET-Mutant, RET Fusion-Positive Thyroid Cancers 

  • The approval is based on P-I/II ARROW study involve the assessing Gavreto (400mg, qd) n people with rearranged during transfection (RET) fusion-positive NSCLC, RET-mutant MTC, RET fusion-positive thyroid cancer and other RET-altered solid tumors 
  • The study demonstrated durable clinical activity in people with/out prior therapy and regardless of RET alteration genotypes 
  • Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations  

Biocryst’s Orladeyo (berotralstat) Received the US FDA’s Approval to Prevent Attacks of Hereditary Angioedema (HAE) 

Published: Dec 03, 2020 | Tags: Biocryst, Orladeyo, (berotralstat), Receives, US, FDA, Approval, hereditary angioedema (HAE) 

  • The approval is based on a pivotal P-III APeX-2 trial assessing Orladeyo (150 mg, qd) in adults and pediatric patients aged ≥12yrs. with HAE 
  • The study demonstrated reduction attacks @24wks. while the reduction was sustained through 48wks. with mean HAE attack rates of 2.9 attacks/mos. In the long-term open-label APeX-S trial, patients completing 48wks. of therapy had a mean attack rate of 0.8 attacks/mos. 
  • Orladeyo (PO) is designed specifically to prevent attacks of HAE in adults and pediatric patients aged ≥12yrs 

Athenex’s Klisyri (tirbanibulin) Received the US FDA’s Approval for Actinic Keratosis on the Face or Scalp 

Published: Dec 15, 2020 | Tags: Athenex, Klisyri, (tirbanibulin), Receives, US, FDA, Approval, Actinic Keratosis, Face, Scalp 

  • The approval is based on P-III studies KX01-AK-003 and KX01-AK-004 that evaluated the efficacy and safety of Klisyri (tirbanibulin, ointment 1%, 10 mg/g) vs vehicle in 702 adult patients in the ratio of (1:1) with actinic keratosis of the face or scalp  
  • Both the studies achieved their 1EPs defined as 100% clearance of the AK lesions @57 days within the treatment areas, complete clearance (44% vs 5% and 54% vs 13%) respectively  
  • Klisyri is the first FDA approved product for Athenex and will be launched in partnership with Almirall in the US during Q1’21  

Myovant’s Orgovyx (relugolix) Received the US FDA’s Approval as the First Oral GnRH Receptor Antagonist for Advanced Prostate Cancer 

Published: Dec 15, 2020 | Tags: Myovant, Orgovyx, (relugolix), Advanced Prostate Cancer 

  • The approval is based on a P-III HERO study assessing Relugolix (360mg loading dose followed by 120mg, qd) vs leuprolide acetate (3mos. depot injection) in patients with advanced prostate cancer. The therapy is expected to be available in Jan’2021 
  • Results: met its 1EPs, sustained testosterone suppression to castrate levels (< 50 ng/dL) @48wks. (96.7% vs 88.8%).  
  • 2EPs include @day4 & 15 suppression of testosterone to castrate levels (56% & 99% vs 0% & 12%); profound suppression of testosterone (< 20 ng/dL) @day15 (78% vs 1%); reduction in PSA by 65% @day15 and by 83% @day 29 

MacroGenics’ Margenza (margetuximab-cmkb) Received the US FDA’s Patients with Pretreated Metastatic HER2-Positive Breast Cancer 

Published: Dec 16, 2020 | Tags: MacroGenics, Margenza, Receives, US, FDA, Metastatic, HER2-Positive Breast Cancer 

  • The approval is based on P-III SOPHIA trial involves assessing of Margenza (IV, 15 mg/kg, q3w) vs Herceptin (trastuzumab, IV, 6mg/kg or 8mg/kg for loading dose) both combined with CT in 536 patients in a ratio (1:1) with HER2-positive m-BC who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.  
  • The study showed 24% reduction in the risk of disease progression or death, ORR (22% vs 16%), The final OS analysis is expected in the H2’21  
  • Margenza is an Fc-engineered, mAb that targets the HER2 oncoprotein, also being evaluated in multiple trials for HER2+ gastroesophageal cancer & various HER2+ tumors 

Ridgeback’s Ebanga (mAb114) Received the US FDA’s Approval for the Treatment of Ebola 

Published: Dec 22, 2020 | Tags: Ridgeback, Ebanga, mAb114, Receives, US, FDA, Approval, Ebola 

  • Ebanga is now approved for treatment of infection caused by Zaire ebolavirus in adult & pediatric patients (including neonates born to a mother who is RT-PCR+ for Zaire ebolavirus infection) 
  • The efforts of the PALM study demonstrated Ebanga’s safety and efficacy in a randomized controlled trial conducted during the 2nd largest and longest outbreak in DRC history 
  • In 2020, Ridgeback initiated a compassionate use protocol for Ebola patients during the DRC’s 11th Ebola outbreak in Équateur Province and will provide it to all PCR+ Ebola patients under the protocol 

Urovant’s Gemtesa (vibegron) Received the US FDA’s Approval for Overactive Bladder  

Published: Dec 23, 2020 | Tags: Urovant, Gemtesa, Vibegron, US, FDA, Approval, Treatment, Overactive Bladder, OAB 

  • The approval is based on P-III EMPOWUR and EMPOWUR long term extension study that involves assessing Gemtesa (75mg, qd) vs PBO in ~4000 patients with OAB for 12wks. 
  • The study resulted in reductions in daily UUI, micturitions, and urgency episodes and an increase in the volume voided 
  • Gemtesa is a small-molecule β3 adrenergic receptor agonist therapy that relaxes the detrusor bladder muscle so that the bladder can hold more urine, thus reducing symptoms of OAB. Gemtesa is the first oral branded FDA’s approved OAB medication since 2012, and it is the first product approval for Urovant Sciences 

Related Post: Insights+: The US FDA New Drug Approvals in November 2020

The post Insights+: The US FDA New Drug Approvals in December 2020 first appeared on PharmaShots.

Analysis of Recent National Trends in Medicaid and CHIP Enrollment

This data note looks at national and state-by-state Medicaid and CHIP preliminary enrollment data through September 2020, as states were still in the early stages of experiencing the health and economic effects of the coronavirus pandemic. After declines in enrollment from 2017 through 2019, preliminary data show that total enrollment grew to 77.3 million in September, an increase of 6.1 million from actual enrollment in February 2020 (8.6%), right before the pandemic and when enrollment began to steadily increase.

Insights+ Exclusive: Key Takeaways from the Webinar on HEOR/ HTA: The Evolving Role in the Indian Healthcare Ecosystem

  • Intellimed Healthcare Solutions organized an online webinar on “Health Economics and Outcomes Research/ Health Technology Assessment: The evolving role in the Indian Healthcare Ecosystem” on 15th January 2021.
  • The objective was to gain insights into the current scenario and the need for HEOR/HTA in India.
  • Health economics and outcomes research (HEOR) is a growing field that provides important information for making healthcare coverage and access decisions.

The pharmaceutical & Medtech industry invests heavily in HEOR studies alongside clinical trials and continues to collect clinical, humanistic, and economic real-world data throughout the life cycle of a therapeutic product. Even after such efforts, why are some medicines not affordable and accessible? Why is there still a gap between healthcare and socioeconomic status? How can we equalize access to healthcare? The honorable speakers, panelists, and moderator addressed these important questions

Dr. K. Srinath Reddy, MD, President of Public Health Foundation of India (PHFI), delivered the key-note address. He said “the economic dimensions of health are seen to go wrong when we have a pandemic or health emergency, but afterward the health system is neglected and very scant attention is paid to the need for financing health and optimizing the investments in health interventions. This is where health economics comes in as a very important discipline. He highlighted the need for universal health coverage, reduced out of the pocket expenditure. Dr. Reddy said “horizontal equity is often seen as treating everyone equally.  Many people have been deprived of essential services and a huge gap exists in health status. Vertical equity would bridge health equity gaps, by providing additional resources/ service. Thus, we need to balance horizontal and vertical equity as we construct the universal health coverage package. Health economics and health technology play a big role in optimizing resources, ensuring cost-effectiveness and equity benefits. He spoke about a few health initiatives such as “The National Digital Health mission Rashtriya Swasthya Bima Yojana and Ayushman Bharat”. Unfortunately, even when access to healthcare increased, financial hardships did not decrease in India. He concluded by saying “we need more health for our money i.e. for every rupee invested we must get a better return, more public financing for health, allocative and utilization efficiencies. That is why we need a better understanding of HEOR and HTA and integrate it into our health systems”.

Dr. V.M. Katoch, MD MD, FNASc, FASc, FAMS, FNA NASI-ICMR Chair on Public Health Research at Rajasthan University of Health Sciences (RUHS), Jaipur; President, JIPMER, Puducherry; President, AIIMS, Madurai; Former Secretary, Department of Health Research, Govt of India and Director-General, Indian Council of Medical Research in his special address suggested that we look at healthcare-related problems in a scientific way. According to him, the best intervention for the majority of the population must be the chosen one. This pandemic has brought back health to the center stage. He said “HTA based on sound health economics creates a vibrant instrument by which there is fair play and people get good healthcare interventions.

Dr. Rajesh Balkrishnan, Ph.D., Professor of Public Health Science at the University of Virginia, School of Medicine was the guest speaker for the webinar. He highlighted his research on “Real-world effectiveness of medications in terms of affordability and adoption”. Dr. Balkrishnan spoke about the 3 E`s – Effectiveness, Efficiency, and Equity, that help in evaluating the healthcare system. He gave an overview of the conceptual model of health determinants in terms of population perspectives.

The first panelist Mr. A Vaidheesh, Chief Executive Officer at Northstar Asis LLP, said “Integration in demand with those who bring the innovation is vital for growth and innovation of the healthcare industry?

  • Mr. Manoj Saxena, Managing Director, Bayer Zydus Pharma, and CDH South Asia Bayer Pharma, our second panelist said, “In India, 70% of the expenses are out of pocket, and if the clinicians have visibility on the health economics of the treatment along with clinical evidence, it makes the composite value of treatment more clear. He said, “Around 50% of Indians suffer from anemia or iron deficiency anemia (IDA), and the cost to GDP because of anemia is 22 Billion dollars. Even though the treatment for anemia is not that expensive, why is the incidence so high? HEOR/HTA could be applied to find out the reason for lesser awareness and use of such interventions, to reduce anemia associated maternal death. Interestingly, anemic patients when become adults earn 2.5% less than their healthy peers. HEOR/HTA has applications in both, reimbursed markets and out of pocket markets to evaluate newer innovative therapies.
  • Mr. Omar Sherief Mohammad, Managing Director, Roche Diabetes Care India Pvt. Ltd. our third panelist said,This pandemic has increased connectivity between HCPs, doctors and their patients and also data sharing. Improvement in adherence to medication and self-monitoring has evident. HEOR is a part of Pharmacoeconomics whereas HTA is a different concept”.Mr. Omar also said that it is vital to bean honest industry partner and bring innovation along with an understanding and importance of HEOR.
  • The fourth panelist, Dr. Anish Desai, MD, Director of Intellimed Healthcare Solutions highlighted the importance and need for real-world evidence, both in the pharma and Medtech world. From his experience, he said, how data generation and dissemination improved insulin penetration amongst diabetics. Converting bariatric surgery, from a cosmetic procedure to a therapeutic intervention but challenging but successful, said Dr. Anish. Finally, he concluded by laying down the importance of patient centricity in assessing healthcare interventions.

The post Insights+ Exclusive: Key Takeaways from the Webinar on HEOR/ HTA: The Evolving Role in the Indian Healthcare Ecosystem first appeared on PharmaShots.

Join the Daily Dozen Digest

My Daily Dozen checklist includes all the healthiest of healthy foods I try to fit into my routine each day. Whether you have been tracking your Daily Dozen for years or are brand-new to it, you’re invited to join us for 11 weeks of support emails to help you Do the Dozen with ease! Each week, we will send you an email with tips, tricks, facts, and tasty recipes to help you incorporate some of the Daily Dozen into your regular meal rotations.

Registration is now open, and you’ll get your first Do the Dozen email as soon as you sign up. If you participated in this series last fall, you’re invited to register again if you want a refresher or another round of support. Sign up here.

 

Valentine’s Gift Fundraiser

This Valentine’s Day, give your loved one the gift of a personal message from Dr. Greger in a special video he’ll record on your behalf. The first 100 supporters to donate $100 using this form will get a personalized video via email for their loved one. Just tell Dr. Greger what you’d like him to say!
 
 
 
 
 
 
 

Last Day to Register for Our Free Webinar

With death rates as much as six times higher in Black America than white America, COVID-19 pointed a glaring spotlight at racial health disparities in the United States. In my upcoming hour-long live webinar, I’ll address the question of why Black Americans have been living sicker and dying younger than their white counterparts way before the pandemic started. Even with the same education and socioeconomic resources, Black Americans suffer disproportionately from chronic disease. What role may dietary patterns be playing, and what happens when you feed people soul food that’s good for the soul and put plant-based diets to the test?

Webinar Date & Time: Friday, January 22 from 3pm to 4pm ET

 

Free B12 Infographic

New subscribers to my newsletter will receive a free infographic on my latest B12 recommendations.
Don’t worry if you’re a current subscriber. You can download your copy right here!

 
 
 
 
 
 

New Year’s Resolutions Already Slipping?

Join Dr. Greger and psychologist Dr. Doug Lisle in this mini course, hosted by health coach Dr. Jen Howk. From January 26 to 29, this new webinar series will discuss why willpower alone is often not enough to enable us to reach our health goals. Register at www.jenhowk.com

 

 

 

 

 

 Do Vegans Really Have More Bone Fractures?

Tune in to the recording of the live, one-hour presentation on the recent EPIC-Oxford study findings that suggested plant-based eating has adverse effects on bone health.

 

What’s the Ideal BMI?

Is there a unisex chart to see what your optimal weight might be based on your height?

 

 

Flashback Friday: Dr. Greger in the Kitchen—My New Favorite Dessert

Dr. Greger whips up some matcha ice cream inspired by a recipe in his How Not to Die Cookbook.

 

 

Volunteer Spotlight: Viviana Garcia

Reading How Not to Die back in 2016 had a great impact on me, so I adopted a WFPB diet and joined NutritionFacts as a volunteer translator. It is an honor to contribute so that science-based information on nutrition is available to people in Spanish-speaking countries. Our healthier choices have a positive effect on our families, on public health worldwide, and on the health of our planet, so I appreciate this opportunity to collaborate with a great team.

My favorite recipe: Golden quinoa tabouli from Dr. Greger’s How Not to Die Cookbook, as I love chickpeas and turmeric!

 

Live Q&As January 28

Every month, I do live Q&As right from my treadmill, and January 28 is the day.

Join on our Facebook page or YouTube channel at 3pm ET. I’ll be streaming to both at the same time.

I am also excited to have the opportunity to speak live with Tracye McQuirter, MPH. Join us on Instagram at 5pm ET.  

Tracye McQuirter, MPH, is an award-winning public health nutritionist, 34-year vegan, and author of Ageless Vegan and By Any Greens Necessary. She recently created the 10,000 Black Vegan Women movement, helping 12,000 women and counting to take back control of their health.

You can find links to all of my past live Q&As here on NutritionFacts.org. If that’s not enough, remember I have an audio podcast to keep you company.

We aim to share helpful health content each month, but we also want your input on how we can make it even better. Please complete this short survey to share your feedback.

 

In health,
Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live, year-in-review presentations:

Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D

Shots:

  • The approval is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification
  • Result: 2.0 mg dose achieved significant and superior reduction in HbA1c, both doses are safe and well-tolerated profiles
  • Ozempic is a glucagon-like peptide-1 (GLP-1) analogue and is currently approved in the US for 0.5 mg and 1.0 mg doses to treat T2D in adults and to reduce the risk of MACE in adults with T2D mellitus and established CV disease

Click here ­to­ read full press release/ article | Ref: GlobeNewswire| Image: Business Medical Dialogues

The post Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D first appeared on PharmaShots.

The U.S. Likely Can’t Reach Herd Immunity Without Vaccinating Kids

A few days after Christmas, Molly Hering, 14, and her brother, Sam, 12, got their first shots as part of the Pfizer COVID-19 vaccine trials for kids. Their mom had heard about a clinical trial being conducted at Cincinnati Children’s Hospital, and Molly told me that she’d agreed to join because she wanted to contribute to the vaccine-development effort.

Molly and Sam’s dad was recently hospitalized with COVID-19. (He recovered.) Both kids have spent most of the past year dealing with Zoom school and its attendant technical glitches. Molly finally went back to in-person ninth grade this month, but masks and social distancing are required at school. Like everyone else, she’s looking forward to the end of the pandemic. “I’ll finally be able to go to school normally,” she said.

With COVID-19 vaccines proven to be safe and effective in most adults, Pfizer and Moderna have both begun U.S. trials for kids as young as 12. And if those trials go smoothly, the vaccines will be tested in younger and younger kids. This is typical for new vaccines: “It’s called the age deescalation strategy,” Carol Kao, a pediatrician at Washington University in St. Louis, told me.

There are some 70 million kids in the U.S., nearly a quarter of the country’s population. Children in general are not especially vulnerable to COVID-19; most infections are mild or even asymptomatic. In some very rare cases—less than 0.01 percent—young patients can develop a complication called multisystem inflammation syndrome, or MIS-C, but it is generally quite treatable in a hospital.

Vaccinating kids, however, is often not just about the direct and immediate benefits to them. It’s also meant to protect children against diseases that would otherwise become more dangerous for them as adults—measles, mumps, and chicken pox are three common examples—and dampen the overall spread of these diseases. In the short term, the primary reason to vaccinate children against COVID-19 may be that the U.S. will have a hard time reaching herd immunity otherwise.


Vaccines that work in adults generally work in children. But their effects can differ, especially in very young children. In newborns, for example, antibodies passed to them in utero can interfere with the protection conferred by the measles vaccine, which is why that vaccine is not given until babies are 12 to 15 months old. An early version of the pneumococcal vaccine did not work well in children under 2, because it stimulated a part of the immune system that was not yet mature.

Multiple factors determine the recommended age for a vaccination. “For example, when’s the peak incidence of disease? When is a child most likely to respond to the vaccine?” says Cody Meissner, an expert on pediatric infectious diseases at Tufts. The answers to those questions might not align. For instance, the vaccine for HPV, a sexually transmitted virus that can lead to cervical cancer, is given to boys and girls as young as 9 years old because it stimulates a better immune response in preteens than in older adolescents, even though preteens are unlikely to need the protection until later in life.

Even though kids rarely get seriously sick from COVID-19, the vaccine can protect them from an illness that may still be bad enough for them to miss school and their parents to miss work, Jeff Gerber, a pediatrician at Children’s Hospital of Philadelphia, told me. “Even those two-to-three-day illnesses can pile up.” He pointed out that the flu vaccine is recommended for kids, and about the same number of children died of the flu last season as have died of COVID-19 to date.

But the main argument for broadly vaccinating children is that doing so is likely to reduce COVID-19 transmission. Although schools have not been sources of large outbreaks, many switched to distance learning, and most of those that held in-person classes required masks and distancing. If school buildings reopen without these precautions sometime this year, after adults get vaccinated but while kids are still vulnerable, they will essentially be hosting mass gatherings of unvaccinated people, says Jason Newland, a pediatrician at Washington University. “Guess who’s going to end up having it? All the kids,” he told me. “And those kids with certain underlying conditions are disproportionately impacted.” What’s more, kids could bring COVID-19 home from school, even if they don’t have symptoms. “Children could pass it on to Grandma and Grandpa. They can pass it on to another loved one who has diabetes or has obesity or has chronic kidney disease” and is not yet vaccinated, Newland said.

Public-health experts think that if precautions are in place, community transmission is low, and teachers and high-risk people are vaccinated, reopening schools in 2021 will be worth any remaining risk, given the many and wide-ranging consequences of keeping them closed. But the more children are vaccinated, the safer and more normal school reopenings will be.  

The ultimate goal of most vaccination campaigns is not just to protect the individuals who get the vaccines, but to prevent the spread of the disease to those who can’t get it, such as infants and people at risk of allergic reactions. The more transmissible the virus—and unfortunately COVID-19 appears to be evolving to be more transmissible—the more people need to be vaccinated in order to reach herd immunity and stop its spread through a population. The herd-immunity threshold against COVID-19 is estimated to be somewhere between 60 and 90 percent of the population. Because some people can’t get the vaccine and some may be steadfastly opposed to it, the U.S. needs to vaccinate as many of the rest of us as it can. “What we want to do is reduce the number of people who might be contagious to others,” Meissner told me. Children will almost certainly need to be a part of that effort.

A still unanswered question about the COVID-19 vaccines, however, is how well they protect against asymptomatic transmission of the virus. When vaccinated people are exposed to the virus, their bodies’ immune response tamps down its replication—enough to reduce symptoms by 95 percent, according to the results of the Pfizer and Moderna trials for adults. But a person who is vaccinated and then exposed might still carry enough virus to spread it to others. Experts think the vaccines very likely reduce the risk of asymptomatic transmission, but follow-up studies are needed to find out by how much.


How soon the vaccines are available to children will depend on how long the clinical trials and the FDA review process take. In the most optimistic scenario, a vaccine could be available for large numbers of kids, especially older ones, in time for the start of the school year in the fall. But last week, Operation Warp Speed said that Moderna was having trouble recruiting enough participants in its trial for adolescents, having enrolled only 800 out of a planned 3,000. The company’s CEO also said that while Moderna would soon begin trials for kids ages 1 to 11, it did not expect to have results until 2022. Pfizer’s adolescent trial has reportedly finished enrollment, though the company declined to specify when it plans to move on to younger children.

The FDA fast-tracked the COVID-19 vaccines for adults using a process called emergency use authorization. But the normal vaccine-approval process may be more appropriate for children, says Vanderbilt’s Tina Hartert, who is leading a study on the incidence of COVID-19 in kids. Approval will take more time for several reasons. For example, the FDA has said that it wants to see more safety data—six months or more depending on the novelty of the vaccine technology—compared with the two months required for emergency use.

The newness of the COVID-19 vaccines combined with the mildness of the disease in children might lead to hesitancy in some parents. When the chicken pox vaccine first became available, in the 1990s, uptake was slow—until public schools started requiring it. Meissner, who sits on the FDA’s vaccine advisory committee, said he thinks schools are unlikely to require a vaccine that is authorized only for emergency use. But there is genuine debate among advisory groups about whether to mandate COVID-19 vaccination at all. “Once you require a vaccine,” Meissner says, “a lot of people who ordinarily might get the vaccine become indignant and say, ‘I’m not going to be told what I have to do for myself or my family.’”

In the long term, the COVID-19 virus is unlikely to go away entirely—and neither is the need for vaccination. If the virus continues to mutate or if immunity wanes, annual vaccinations or boosters every few years might be necessary. The vaccines could also become part of the recommended childhood immunization schedule. Experts say this is the best way to ensure that the entire population remains protected. “The most successful implementation programs are universal pediatric programs,” Kathleen Neuzil, a vaccine researcher at the University of Maryland School of Medicine, told me. Parents are already used to their children getting shots from pediatricians, and pediatricians are already used to vaccinating large numbers of children. Although children may not be particularly vulnerable to COVID-19, they will be when they reach adulthood. And vaccinating large numbers of adults, as the world is currently finding, is very difficult indeed.

Molly Hering, who is participating in the Pfizer trial, doesn’t yet know whether she got the placebo or the actual vaccine. She and her brother are using an app to track their side effects; she had some nausea and headaches after she first got the shot, while he had a low fever. They are going back for their second shots this week. For childhood vaccinations to help slow the spread of the virus, more volunteers will have to join them in the trials.

Computational approach shows antibiotic resistance may spread more easily than expected

Antimicrobial susceptibility testing in petri dish - idea of antibiotic resistant bacteriaNew research suggests that bacteria could be developing antibiotic resistance so rapidly because of significant genetic transfer between bacteria in our ecosystems and to humans.

The World Health Organization (WHO), says antibiotic resistance is one of the greatest threats to global health, food safety and development. It already causes over 33,000 deaths a year in Europe alone.

The most important mechanism for spreading antibiotic resistance is called conjugation. When two bacteria cells come into contact, they share resistance genes to each other by copying and transferring plasmids – small DNA molecules where bacteria store some of their genes outside the chromosome. Conjugation can occur between completely different species of bacteria.

“In recent years, we have seen that resistance genes spread to human pathogens to a much greater degree than anyone expected,” said Jan Zrimec, researcher in systems and synthetic biology at Chalmers University of Technology, Sweden. “Many of the genes appear to have originated in a wide array of bacterial species and environments, such as soil, water and plant bacteria.

“This has been difficult to explain, because although conjugation is very common, we have thought that there was a distinct limitation for which bacterial species can transfer plasmids to each other. Plasmids belong to different mobility groups, or MOB groups, so they cannot transfer between just any bacterial species.”

However, in his study Zrimec found that genetic transfer may be much more boundless and widespread than previously anticipated.

He used, among other things, a novel algorithm he developed that can identify specific DNA regions, called oriT regions, that are necessary for conjugation from databases consisting of genetic sequences from the DNA of thousands of plasmids. The algorithm can also sort plasmids into MOB groups based on the identified oriT regions.

In the study he used the algorithm to explore known gene sequences from over 4,600 naturally occurring plasmids from different types of bacteria. Some of his most important findings were that:

  • The number of oriT regions may be eight times higher than previously identified.
  • The number of mobile plasmids and bacterial species with mobile plasmids may be twice as high as hitherto predicted.
  • The structure of the oriT regions in more than half of the plasmids match a conjugation enzyme from another plasmid that has previously been classified in a different MOB group. This means that there may be transfer mechanisms between large numbers of bacterial species and environments where we previously believed there were barriers.

“These results could imply that there is a robust network for transferring plasmids between bacteria in humans, animals, plants, soil, aquatic environments and industries, to name a few,” Zrimec explained. “Resistance genes occur naturally in many different bacteria in these ecosystems, and the hypothetical network could mean that genes from all of these environments can be transferred to bacteria that cause disease in humans.

“This may be a possible reason for the rapid development of resistance in human pathogens that we have observed in recent years. Our extensive use of antibiotics selects for resistance genes, which could thus flow in from a much larger naturally occurring genetic reservoir than we previously estimated.”

The scientific article was published in Microbiology Open.

The post Computational approach shows antibiotic resistance may spread more easily than expected appeared first on European Pharmaceutical Review.

Pfizer COVID-19 vaccine effective against B.1.1.7 variant from UK

COVID-19 vaccinePfizer and BioNTech have announced results from an in vitro study that provides additional data on the capability of sera from individuals immunised with the Pfizer-BioNTech COVID-19 vaccine to neutralise a SARS-CoV-2 UK strain.

Also known as B.1.1.7 lineage or VOC 202012/01, the strain is a rapidly spreading variant of SARS-CoV-2 initially detected in the UK that carries a larger than usual number of genetic changes with 10 mutations located in the coronavirus Spike (S) protein.

BioNTech and Pfizer have previously published data from an in vitro study that evaluated one of the key mutations (N501Y) in the UK strain, which is also shared by the South African strain. That study showed efficient neutralisation of the N501Y mutated S protein bearing virus by-sera of individuals who had received the Pfizer-BioNTech COVID-19 vaccine.

The current in vitro study investigated the full set of UK strain S protein mutations. A pseudovirus featuring the UK strain S protein was first generated. The pseudovirus recapitulates SARS-CoV-2 virus binding and cell entry. Sera from trial participants was found to inhibit the pseudovirus bearing the UK strain at the same level of efficacy as the unmutated Wuhan SARS-CoV-2 S protein.

The researchers therefore conclude that the UK virus variant should be prevented by immunisation with BNT162b2.

Pfizer and BioNTech say that they are encouraged by these early in vitro study findings. However they highlight that further data are needed to monitor the Pfizer-BioNTech COVID-19 vaccine’s effectiveness in preventing COVID-19 caused by new virus variants. Should a vaccine strain change be required to address virus variants in the future, the companies believe that the flexibility of BioNTech’s proprietary mRNA vaccine platform is well suited to enable such adjustment.

The results were published on the pre-print server bioRxiv and have been submitted to a peer-reviewed journal.

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In the final days of Trump administration, agencies clashed over how to regulate medical AI

The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the FDA said it will issue guidance on how changes to algorithms should be regulated as they “learn.”

FDA approves Bayer/Merck & Co heart failure drug

Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market.

Verquvo has been approved to reduce risk of cardiovascular death and heart failure hospitalisation in adults with symptomatic chronic heart failure and ejection fraction less than 45%.

The drug can be used after hospitalisation for heart failure or in patients in need of intravenous diuretics.

But the drug is entering an increasingly competitive market, where Novartis and AstraZeneca are vying for supremacy.

Entresto (sacubitril+valsartan) was FDA-approved in patients with reduced ejection fraction five years ago.

Meanwhile, AstraZeneca’s Farxiga (dapagliflozin), originally a diabetes drug, was approved in the US last year in heart failure with reduced ejection fraction.

The FDA is also quickly reviewing Boehringer Ingelheim’s Jardiance (empagliflozin) in heart failure, AZ’s big rival in the market for SGLT2 inhibitor class drugs.

Verquvo’s approval is the first for patients following a hospitalisation for heart failure or who need for outpatient IV diuretics and is based on the results of the pivotal phase 3 VICTORIA trial and follows a priority regulatory review.

VICTORIA’s main efficacy goal was to determine whether Verquvo is superior to placebo, both in combination with other heart failure therapies, in reducing the risk of cardiovascular death or heart failure hospitalisation in adults with symptomatic chronic heart failure and ejection fraction less than 45% following a worsening heart failure event.

Verquvo met the primary efficacy objective, with the study showing there was a 4.2% reduction in annualised absolute risk in the treatment group compared with placebo.

Therefore, 24 patients would need to be treated over an average of one year to prevent one death or heart failure hospitalisation.

VICTORIA is a large phase 3 trial involving 5,050 patients with heart failure with ejection fraction less than 45%.

Dr Paul W. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial, said: “Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalisation after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalisation.

“By some estimates, more than half of these patients are rehospitalised within a month of discharge due to a worsening event and approximately one in five die within two years.

“The approval of Verquvo provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”

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Health literacy needs support, now more than ever

The COVID-19 pandemic has brought healthcare guidelines and scientific advances front-of-mind on a global scale, in the process highlighting long-standing gaps in health literacy as well as an opportunity for pharma.

It’s long been known that many people struggle to access, understand and use health information and services to make decisions about their health.

As the WHO noted in 2013: “Knowledge societies in the 21st century confront a health decision-making paradox. People are increasingly challenged to make healthy lifestyle choices and manage their personal and family journeys through complex environments and health care systems but are not being prepared or supported well in addressing these tasks.”

Just how unprepared people are has been laid bare time after time. According to the 2012 European Health Literacy Survey, 29% to 62% of people across eight EU member states had inadequate or problematic health literacy.

And that’s before national television briefings began on COVID’s ‘R number’, an ever-mutating set of restrictive rules and an evolving understanding of the science behind a novel coronavirus first identified on 7 January 2020.

Alongside COVID’s devastating effects, 2020 also saw a raging misinformation pandemic as fake science and conspiracy theories spread rampantly online, often peddled by those in power, such as the former US president Donald Trump.

“In times of uncertainty and ‘fake news’, it is our responsibility to provide guidance and clarity to our patients and consumers”

A challenge to self-care

The spread of health misinformation at a time when we are increasingly expected to practice self-care wherever possible has been a particularly pernicious modern development and has turbo-charged dangerous ‘anti-vax’ ideas.

Filippo Lanzi is EMEA regional head for GSK Consumer Healthcare. His company is one of those in pharma looking to help improve health literacy and support people to manage their everyday health.

“In times of uncertainty and ‘fake news’, it is our responsibility to provide guidance and clarity to our patients and consumers,” he said.

“If we want to overcome misinformation and improve health literacy, we need to explain science to people in a way they understand, using the right channel, at the right time, so they can make informed decisions and find the products and sources of information they know they can trust.”

However, a GSK-commissioned study on the health-economic benefits of self-care in Europe published last month found that poor health literacy continues to pose a major challenge to self-care.

It revealed that 80% of Europeans accept that it is their responsibility to manage their own health and are willing to do so, but only 2 in 10 feel very confident in managing their own health.

Discussing the study’s findings Professor Lieven Annemans, senior full professor health economics at Ghent University, said: “Better health literacy creates empowered individuals who can take better control of their own health and make the right choices. There is a clear opportunity for governments, health systems, regulators and healthcare professionals to work together to remove this barrier in order to enable people to engage in self-care with confidence.”

An ‘infodemic’ of misinformation and fake news

Alongside pharma efforts to highlight the scale of the health literacy problem and work towards solutions, it’s clear that the problem of misinformation requires action from both governments and the tech giants that have allowed it to spread almost unchecked.

Facebook said in March it had been “taking aggressive steps to stop misinformation and harmful content from spreading” ever since the WHO declared COVID-19 to be a global public health emergency at the beginning of 2020.

In a sign that more concerted action was needed, in April the social network started displaying messages in people’s News Feeds if they had interacted with COVID-related posts subsequently deemed to have violated its policies. In June it started providing more context to COVID-related links and in September it introduced a forwarding limit to its Messenger service.

Those steps were followed in October with a new global policy that banned any adverts that would discourage people from getting vaccinated, whether for COVID, the flu or anything else. “We don’t want these ads on our platform,” the company noted, somewhat belatedly.

Meanwhile, Google started this year with the launch of a $3 million fund to tackle misinformation about COVID-19 vaccines.

Alexios Mantzarlis, news and information credibility lead at Google News Lab, said: “The uncertainty and developing nature of the coronavirus pandemic continues to generate related misinformation. The global rollout of COVID-19 vaccines is exacerbating a perennial problem of misinformation about immunisation.”

The company’s new fund is global in scope and open to news organisations with a proven track record in fact-checking and debunking activities as it aims to broaden the audience of fact checks, particularly to those who may be disproportionately affected by misinformation.

Individuals too have an important role to play, and the WHO has seven tips to help people flatten what it calls the ‘infodemic’ curve.

Pharma’s chance to help

Starting with prescribing information and packaging leaflets, there is a huge opportunity to make health information clearer and easier to understand.

Efforts are afoot to do so and it’s something the Patient Information Forum (PIF) aims to support through the health information accreditation scheme it launched last year.

“One of the things that COVID-19 has really highlighted is how important health literacy is. Materials don’t just need to be evidence based, they also need to be easy to use and understand,” Sophie Randall, PFI’s head of strategy and partnership told pharmaphorum.

“Industry has been under pressure from the EMA to improve the health literacy of prescribing information and packaging leaflets. We know that is complicated because of regulation, but we also think they can rise to the challenge.”

Beyond that pharma companies could be looking to harness their decades of experience in disease awareness for health literacy materials or easy-to-understand vaccine information. This could build on the industry’s already sterling efforts in working against COVID and there’s certainly a clear need for it.

About the author

Dominic-TyerDominic Tyer is a journalist and editor specialising in the pharmaceutical and healthcare industries. He is currently pharmaphorum’s interim managing editor and is also creative and editorial director at the company’s specialist healthcare content consultancy pharmaphorum connect. Connect with Dominic on LinkedIn or Twitter

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Phase II trial to establish whether alisporivir can prevent COVID-19 progression

SARS-CoV-2The first patient has been dosed in a Phase II trial evaluating efficacy and safety of Debiopharm’s antiviral alisporivir (Debio 025) the treatment of early stage, hospitalised COVID-19 patients not requiring medical ventilation nor exhibiting signs of Acute Respiratory Distress Syndrome (ARDS).

The company said the primary objective of the investigator-initiated, randomised, open-label clinical trial is to evaluate the reduction in COVID-19 viral load in alisporivir treated patients. The secondary objective involves the analysis of clinical and radiological efficacy, safety and tolerability of the compound plus Standard of Care (SOC) compared to SOC alone.

Patients in the investigational arm will receive 600mg of alisporivir either orally or via a nasogastric tube, twice daily for 14 days. The trial will be carried out in multiple centres in France including the Henri Mondor Hospital Group.

Alisporivir is a macrocyclic cyclophilin inhibitor, which the company believes could prevent the life-threatening complications of COVID-19 by helping to combat the immune overreaction which the virus causes.

“New evidence generated by our research group suggests that alisporivir’s antiviral activity could work by decreasing the viral load in the cells and reducing the risk of pulmonary damage caused by an excessive immune response from infected patients. The treatment is expected to be most effective in the early stages of infection by inhibiting the virus’ capacity to replicate and multiply, potentially due to the drug’s capacity to accumulate in the lungs and strong distribution throughout the body overall,” explained Professor Jean-Michel Pawlotsky, leader of the trial and Head of the Biology and Pathology Department at the Henri Mondor Hospital Group, Greater Paris University Hospitals.

“The preliminary evidence provide a scientific rational for this Phase II trial, with hopes that treatment will help patients to avoid advancing to more life-threatening phase of the COVID-19 infection. We are thrilled that this compound will be tested for its ability to fight this pandemic and save lives,” remarked Bertrand Ducrey, Chief Executive Officer of Debiopharm.

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Janet Woodcock to lead FDA on interim basis

Janet Woodcock to lead FDA on interim basis

cbaker_admin
Thu, 01/21/2021 – 07:00

Janet Woodcock, MD, the longtime director of FDA’s Center for Drug Evaluation and Research, is set to serve as interim FDA commissioner after current Commissioner Stephen Hahn, MD, departs Wednesday. The incoming Biden administration has not yet nominated an FDA commissioner to permanently replace him. Woodcock, who joined FDA in 1986, has been involved with Operation Warp Speed, the multi-agency task force aimed at accelerating the development of COVID-19-related drugs and other medical products. In an interview, Hahn noted the agency is actively seeking to make more COVID-19 vaccine available soon by connecting companies with manufacturing capacity with vaccine companies that have reached the limits on how much they can produce. “We can’t dictate” the process of connecting the firms, “but we can play matchmaker. I’m expecting increased capacity in the next couple of months,” he said.

Older adults begin to drop out of Novavax vaccine trial to get Pfizer and Moderna vaccines

Older adults begin to drop out of Novavax vaccine trial to get Pfizer and Moderna vaccines

cbaker_admin
Thu, 01/21/2021 – 07:00

As it tests its candidate COVID-19 vaccine, Novavax is seeing older adult volunteers leave the study to get immunized with the Pfizer or Moderna products already known to be effective against coronavirus. The exodus has been motivated in part by state efforts to open up vaccination to broad swaths of Americans aged 65 years and older—not just residents of long-term care facilities. While good news for people in that demographic, the expansion is contributing to a shortage of participants in vaccine trials that are still underway. Maryland-based Novavax, for instance, needs 30,000 people for its placebo-controlled study, a quarter of whom would fall into the critical age 65-plus category. Without a robust cohort of older adult participants through followup, however, the trial data would carry less weight. Only about 9,000 people were enrolled as of last week. If it fails to recruit enough older adults, company officials plan to ask FDA to consider data from a U.K. trial that is fully populated. FDA is open to that possibility. “We’re not going to cut corners, but we’re not going to stand on ceremony,” explains one senior agency official. The official added, “It’s not like we’re going to sit there and make rules to make it difficult to use foreign data.”

New California variant may be driving virus surge there, study suggests

New California variant may be driving virus surge there, study suggests

cbaker_admin
Thu, 01/21/2021 – 07:00

As researchers in California searched in December for the U.K. coronavirus variant in patient samples, they discovered that California had its own variant. The new mutant is linked to a strain known as CAL.20C that likely emerged in July but started rapidly spreading in November. The CAL.20C strain accounted for more than one-half of the virus genome samples collected in Los Angeles laboratories on January 13, according to a new study. Jasmine Plummer, a research scientist at Cedars-Sinai Medical Center in Los Angeles, who worked on the study, says: “We had our own problem that didn’t cross over from Europe. It really originated here, and it had the chance to start to emerge and surge over the holiday.” There is not yet evidence that CAL.20C is more likely to cause death or is more contagious compared with other coronavirus variants. However, Eric Vail, director of molecular pathology at Cedars-Sinai, believes it is possible that CAL.20C is playing a key role in the significant increase in cases in Southern California’s hospitals.

New CDC director pledges to speed vaccination, restore trust in agency

New CDC director pledges to speed vaccination, restore trust in agency

cbaker_admin
Thu, 01/21/2021 – 07:00

New CDC Director Rochelle Walensky, MD, is ready to tackle America’s COVID-19 crisis, even as a highly contagious mutation of the virus looms over the nation. One of her top priorities, she said in an interview, is to dispel public skepticism over the vaccines. Not only is it important to reinforce the need for protective masks and other precautions, Walensky says CDC must get through to Americans who are declining the vaccine. “Right now is the time to do that outreach, to do that education, to understand why it is they may not want it and what it is that they need to understand in order to want it,” the physician and researcher says. Walensky, who comes to CDC from Massachusetts General Hospital, where she served as chief of infectious diseases, is also challenged to help states improve their vaccination programs and to restore flagging trust in the agency following political interference under the Trump administration. CDC will hold regular press briefings, release current data, and announce changes in guidance, she notes. Walensky also will try to bolster U.S. public health departments and modernize CDC’s outdated data systems.

Report faults ‘broken’ system for insulin price spikes

Report faults ‘broken’ system for insulin price spikes

cbaker_admin
Thu, 01/21/2021 – 07:00

A report from the offices of Sens. Chuck Grassley (R-IA) and Ron Wyden (D-OR), who lead the Senate Finance Committee, concludes that insulin prices are rising because of a “broken” system that rewards insulin makers for raising drug costs. The report states, “Rather than seeking to undercut its competitors’ pricing, from 2014 on Novo Nordisk engaged in a cat-and-mouse strategy of pricing that followed Sanofi’s price increases closely, sometimes mirroring them within days or even hours.” The authors of the report analyzed more than 100,000 pages of internal documents from various companies. They found companies “aggressively” raised the list prices of insulin products “absent significant advances in the efficacy of the drugs.” The report also cites PBMs, which charge fees and are paid a percentage of the rebate based on the drug’s list price. As a result, drug companies raise the list prices of their drugs so PBMs get larger rebates and drugmakers can secure coverage of the drug by health plans, according to the senators. The study authors noted that in July 2013, Sanofi offered rebates between 2% and 4% of a drug’s list price for inclusion on a health plan’s list of covered drugs. In 2018, Sanofi’s rebates were as high as 56%. The new report also included detailed list price increases for a number of insulin products.

Changes to MA and Part D will provide better coverage, more access and improved transparency for Medicare beneficiaries

Changes to MA and Part D will provide better coverage, more access and improved transparency for Medicare beneficiaries

cbaker_admin
Thu, 01/21/2021 – 07:00

CMS issued a final rule designed to reduce cost sharing for enrollees in Medicare Advantage and Part D prescription drug programs. The changes will result in an estimated $75.4 million in savings to the federal government over the course of a decade. The final rule will require Part D plans to implement a real-time benefit comparison tool starting January 1, 2023, so enrollees can obtain information about lower-cost alternative therapies under their prescription drug benefit plan. Enrollees would have a better idea of what they will need to pay before they arrive at the pharmacy counter. A similar CMS requirement for Medicare Part D plans that took effect on January 1, 2021, allows users to access a real-time drug benefit tool. Enrollees choose the prescription drug plan that is suitable for their needs. Under the final rule, CMS is allowing Part D plans to have a second, “preferred” specialty tier with a lower cost sharing level than their other specialty tier. This change gives Part D plans more tools to negotiate better deals with manufacturers on the highest-cost drugs and lower out-of-pocket costs for enrollees in exchange for placing these products on the “preferred” specialty tier.

FDA finalizes two key rules for companies seeking to market new tobacco products

FDA finalizes two key rules for companies seeking to market new tobacco products

cbaker_admin
Thu, 01/21/2021 – 07:00

FDA issued on Tuesday two final foundational rules for the premarket review of new tobacco products. The rules include additional information on the minimum requirements for the content, format, and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. “The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA Commissioner Stephen M. Hahn, MD. The new final rules are effective 30 days after publication in the Federal Register.

CVS Health is ready to bring the COVID-19 vaccine to the general public, eventually distributing as many as 25m doses a month

CVS Health is ready to bring the COVID-19 vaccine to the general public, eventually distributing as many as 25m doses a month

cbaker_admin
Thu, 01/21/2021 – 07:00

CVS Health said recently it anticipates it will soon be administering up to 25 million vaccines per month across the country. Karen S. Lynch, who is poised to take the helm of CVS on February 1, said: “We have over 90,000 clinicians, through our pharmacists, through our pharmacy techs, through our nurses and nurse practitioners, to administer the vaccine.” Speaking during a conference call with health care industry analysts, she added that CVS developed a digital app for scheduling appointments. Lynch asserted, “We’ll have a ’round-trip ticket’ so to speak so you’ll get your second scheduled appointment and then we can follow up with you with texts and things like that and a phone call because that is a big thing relative to the vaccine, making sure people get their second shot.” CVS had already been using data and analytics to guide health care alongside the digital delivery of health care services. Regarding telehealth, she said: “Many of these changes will be permanent and establish a new normal.” CVS last year also opened 600 HealthHUBs in CVS pharmacies nationwide, according to Lynch. HealthHUBs are staffed with nurses and other medical professionals who offer services between doctor visits and eliminate trips to the emergency room. Lynch noted that 40% of the company’s “Return Ready” coronavirus testing clients are new to CVS Health. She said, “Over 6 million people who tested for COVID at a CVS location are not currently CVS customers.”

WBA planning to unveil tech-enabled health care start-up

WBA planning to unveil tech-enabled health care start-up

cbaker_admin
Thu, 01/21/2021 – 07:00

Walgreens Boots Alliance (WBA) has announced plans to unveil a new tech-enabled health care startup later this year. WBA CFO James Kehoe shared the news at the J.P. Morgan Healthcare Conference, which also included updates on the company’s sale of Alliance Health to AmerisourceBergen, its partnership with Synchrony and Mastercard, and its recent investment in iA. The forthcoming venture, which Kehoe said would launch in its fiscal fourth quarter, is described in WBA’s presentation as “an integrated digital and physical, consumer-centric, technology-enabled health care delivery model, personalized for local communities.” WBA’s ultimate goal is to develop an integrated digital and physical consumer centric health care delivery model. Khoe also noted that Walgreens’ brand equity, store footprint, and pharmacist workforce put it in a unique position to simplify health care delivery through a single platform. He described the effort as a “company within a company” that WBA will allow to work at a faster pace than the overall enterprise, with separate incentives.

Process for COVID-19 vaccination is streamlined in populous Essex County, NJ

Process for COVID-19 vaccination is streamlined in populous Essex County, NJ

cbaker_admin
Thu, 01/21/2021 – 07:00

While the largest mass vaccination campaign in recent memory has frustrated health officials across the nation, the experience in Essex County, NJ, has emerged as a success story. The jurisdiction, which was grappling with the worst COVID-19 surge in the state in November, developed a plan that has been informative, effective, and hindered only by occasional disruptions in the delivery of supplies. The process calls for residents to make an appointment, either by calling a hotline manned by volunteers or by going online to the county website. They receive a unique number to present at designated vaccination sites, including two closed big-box retail locations rented with funding from the federal CARES Act and three schools. Student nurses who volunteer to administer vaccines receive clinical credit-hours in exchange, providing some of the necessary manpower. The county also has activated a software program to capture the data the federal government needs to track vaccinations. The success of the campaign is evident in the thousands of people vaccinated daily, the use of all allotted doses each week—leftover supply is quickly administered to local prisoners to avoid waste—and the fact that other municipalities are approaching Essex for guidance.

Further warning on SGLT2 inhibitor use and DKA risk in COVID-19

Further warning on SGLT2 inhibitor use and DKA risk in COVID-19

cbaker_admin
Thu, 01/21/2021 – 07:00

A study from Boston’s Brigham and Women’s Hospital suggests that people with severe COVID-19 disease should refrain from taking sodium-glucose cotransporter (SGLT)-2 inhibitors. Based on a case series study involving three men and two women prescribed SGLT-2 inhibitors for their type 2 diabetes, the drugs may put coronavirus patients at an elevated risk for euglycemic diabetic ketoacidosis (euDKA) even when presenting glucose levels below 300 mg/dL. SGLT-2 inhibitors, which are diuretics, likely contribute to euDKA because of the associated increase in urinary glucose excretion. In addition, researchers suspect that coronavirus may lower insulin secretion. DKA typically correlates to an underlying state of starvation that may be triggered by vomiting, diarrhea, loss of appetite, and reduced nutritional intake. Naomi D.L. Fisher, MD, the study’s senior author, says euDKA appears to be preventable simply by discontinuing the regimen in COVID-19 patients who experience these symptoms. They can resume the medication once they are feeling better and eating and drinking normally. On the other hand, she notes, there is no need to suspend SGLT-2 inhibitor use as long as patients are eating and drinking as usual and exhibiting mild or no COVID-19 symptoms. The study appears in AACE Clinical Case Reports.

SARS-CoV-2 vaccines: Much accomplished, much to learn

SARS-CoV-2 vaccines: Much accomplished, much to learn

cbaker_admin
Thu, 01/21/2021 – 07:00

Scientists with NIH’s National Institute of Allergy and Infectious Diseases (NIAID) note that while they have gleaned useful information on the first coronavirus vaccines to be distributed publicly, there is still a huge learning curve to navigate. Rare and very seriously adverse effects, for instance, typically do not come to light until after millions of people have been immunized. In addition, while most adverse events occur in the early weeks and months after vaccination, longer-term effects cannot be ruled out. Another question that will continue to demand close attention is the extent to which vaccines protect against infection and transmission, as well as the duration of that protection. Special populations—including children, expectant mothers, individuals with underlying conditions, and people on medications that might influence immune response to vaccines—represent another significant concern and consideration. While the data is trickling in from Pfizer and Moderna’s vaccines, both of which are messenger RNA (mRNA) based, FDA emergency use authorization is likely in the pipeline for AstraZeneca, whose candidate is based on a chimpanzee-derived adenovirus, and for Johnson & Johnson/Janssen, which is using a human adenovirus. Beyond that are prospects from Novavax and Sanofi/GlaxoSmithKline, both of which are produced using recombinant baculovirus. “Acknowledging that there is still much to learn while strongly encouraging vaccination is arguably one of the most critical challenges facing health care providers today,” the NIAID colleagues write. “Having a clear understanding of the data supporting the use of these new vaccines is critical to addressing that challenge.”

Clinical microbiology to play key role in COVID-19 response, report says

A new report has said that clinical microbiology will play a key role in understanding SARS-CoV-2 pathogenesis. According to ResearchAndMarkets, as COVID-19 antiviral drugs and vaccine development intensifies, billions of dollars are being invested in over 100 vaccine candidates forcing labs to work at full and extended capacity.

The report also says that the global market for clinical microbiology will reach a projected market size of $6.1 billion by the year 2027, with a compound annual growth rate (CAGR) of 6.4 percent.  

According to the report, laboratories the world over are busy and have been kept open all through the lockdown period as the race to test for infections and develop drugs, diagnostics and vaccines continues. While industrial laboratories were shut down as part of the containment measures, microbiology labs, virology labs, clinical testing labs, research labs and academic labs have been actively involved in the global fight against the pandemic. By isolating and differentiating microorganisms, clinical microbiology plays a pivotal role in supporting the global response against COVID-19. The ability to quickly and easily classify a deadly virus like COVID-19 in minutes is of immense importance in planning and mobilising medical needs.

The US and Europe together account for a major chunk of the global market, the report says. Growth in the coming years will also stem from developing countries in Asia Pacific, Latin America and the Middle East, driven by increasing automation and growing use of rapid microbiological tests.

The scenario brings good news for the clinical microbiology market as it brings new opportunities for demand growth of instruments and reagents. Asia-Pacific is expected to emerge as the fastest growing market for automated and rapid microbiological tests. Emerging nations, such as China, India and Brazil present significant opportunities due to their constantly growing healthcare infrastructure.

The report predicts that in the post-COVID-19 period, Asia will record growth supported by the rising prevalence of various pathogenic diseases, need to accelerate microbiological testing and discovery of adapting and mutating bacterium. Currently, clinical microbiology is widely used in Asia to identify fungal, bacterial and parasitic infections. 

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Unshackling TP53 in leukaemia with a novel combo; Merus receives funds for cancer research pact; Vera Therapeutics bags $80M; Gritstone appends COVID-19 to the pipeline.

Unshackling the TP53 in leukaemia with a novel combination approach.

Drugs that target the cancer-promoting proteins MDM2 and BET have been attempted in acute myeloid leukaemia (AML) and have not been all that effective on their own. However, they might be useful if they were combined.  

Researchers at the Sanford Burnham Prebys Medical Discovery Institute and the University of Glasgow have early proof a combination strategy may work in AML.

Combining MDM2 and BET inhibitors enhanced the eradication of AML cell lines in lab studies and were more effective than solo treatment in killing cancer in mouse models. The researchers stated in the journal Nature Communications. The combination appears to work by activation of the tumour-suppressing protein p53, they announced. 

A senior author Peter Adams, PhD, a professor at Sanford Burnham Prebys said in a statement that the results were astonishing because previous research had shown that each drug on its own had modest benefit against AML. The new research provides a scientific rationale to advance clinical studies of the drug combination in patients with AML.

The gene TP53 produces the protein p53, a known tumour suppressor. TP53 is frequently mutated across various cancers, so targeting the gene is a popular pursuit in oncology research.

Eli Lilly gives a huge amount in biobucks to Merus for next-gen cancer research pact.

Eli Lilly, via its Loxo Oncology biotech unit, is enlisting to a three-therapy pact with Merus concentrated on T-cell redirecting bispecific antibody work.

Netherlands-based Merus receives USD 40 million upfront and a USD 20 million equity investment from the Big Pharma and USD 1.6 billion in total for three drugs.

These will come out of Merus’ so-called Biclonics platform that develops CD3-engaging, T-cell redirecting bispecific antibody therapies.

Jacob Van Naarden, M.D., chief operating officer of Loxo Oncology, said that CD3-engaging bispecific antibodies are soon becoming one of the most transformative immune-modulating modalities used for cancer treatment.  

Merus is working on its internal pipeline zeroing in on zenocutuzumab (also called MCLA-128), targeting fusions comprising the gene NRG1 that can drive the growth of many different types of cancers.

Vera Therapeutics bags USD 80 Million for trials. 

Vera Therapeutics has raised USD 80 million to take a drug licensed from Merck KGaA into a phase 2b kidney disease clinical trial. The drug, atacicept, has flunked multiple autoimmune clinical trials, but Vera contemplates that it is a prospect in IgA nephropathy.

Atacicept is a recombinant fusion protein made to prohibit B cells selectively. Merck, which initially worked with ZymoGenetics on the candidate, recognised the mechanism of action as a good fit for autoimmune diseases, leading it to run clinical trials in multiple sclerosis, optic neuritis, rheumatoid arthritis and systemic lupus erythematosus (SLE).

The drug failed to improve results in most of those diseases. A phase 2 SLE clinical trial, which lost its primary endpoint, showed improved outcomes in a pre-specified subgroup analysis. 

Data in another indication underpin Vera’s interest in atacicept. In 2017, Merck, having seen atacicept fall short in other diseases, began a phase 2 trial to evaluate the drug in 16 patients with the kidney disease IgA nephropathy.

A 24-week interim analysis published last year linked atacicept to a dose-dependent drop in serum immunoglobulins and improved the urine protein-creatinine ratio. While small, the clinical trial provided early proof of concept that atacicept may improve patients’ outcomes with IgA nephropathy. There is no treatment for the disease. 

Gritstone appends COVID-19 to the pipeline with the NIAID-supported vaccine.

Gritstone Oncology, the biotech company, working on cancer vaccines based on traditional infectious disease immunology, works on a vaccine against SARS-CoV-2. This virus causes COVID-19, which could also work against other viruses in this family in a future pandemic.

The company is making the vaccine alongside the Bill & Melinda Gates Foundation that proffered a grant to fund preclinical work, and the National Institute of Allergy and Infectious Diseases, which will perform a phase 1 study via the Infectious Diseases Clinical Research Consortium.

The vaccine is based on Gritstone’s EDGE technology that utilises machine learning to predict antigens presented by tumour cells or cells infected by a virus that the immune system can see, and work out of the La Jolla Institute of Immunology, which has researched hundreds of patients recovering from COVID-19. 

Under a licensing pact with La Jolla, Gritstone has access to epitopes of the SARS-CoV-2 virus, a part of the virus to which antibodies bind, identified in its studies.

Besides potentially provoking a more robust immune response than the first generation of COVID-19 vaccines does, a new vaccine focused at targets beyond the spike protein could prove useful in the face of new variants of the SARS-CoV-2 virus.

Like the first generation of COVID-19 vaccines, the candidate of Gritstone aims the spike protein of the new coronavirus. However, it also includes other targets that could help boost T-cell immunity.

The post Unshackling TP53 in leukaemia with a novel combo; Merus receives funds for cancer research pact; Vera Therapeutics bags $80M; Gritstone appends COVID-19 to the pipeline. appeared first on DelveInsight Business Research.

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Shots:

  • The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for 24wks. The anticipated PDUFA date is May’2021
  • Results: Over 24wks. predicted median change in FVC measured by home spirometry (-87.7 vs -157.1 mL); change in percent predicted DLco and 6MWD are in favor of Esbriet. Additionally, less loss to lung function and exercise capacity was observed
  • Esbriet is an oral therapy for IPF and is available in more than 60+ countries globally. FDA has granted ODD and BTD to the therapy in 2020

Click here ­to­ read full press release/ article | Ref: Roche| Image: The Indian Express

The post Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD first appeared on PharmaShots.

Philips makes another digital buy, as Thermo adds COVID-19 test maker

Between them, Royal Philips and Thermo Fisher have been driving a mini M&A spree in the medical technology sector, snapping up three companies in the last few weeks.

Dutch electronics giant Philips’ latest move is to acquire Capsule Technologies, which provides software to link data from medical devices and electronic medical records (EMR) within hospitals, for $635 million in cash.

That agreement comes a few weeks after Philips signed a $2.8 billion deal to buy BioTelemetry – a developer of wearable heart monitors – and also follows an alliance just this week with Merck & Co. to develop a digital approach to personalised fertility treatment.

Capsule’s software is already used by more than 2,800 healthcare organisations around the world for device integration, vital signs monitoring and clinical surveillance services, including in intensive care units. It can be used to analyse data at the patient’s bedside, helping to guide treatment, and generated sales of around $100 million last year.

The platform is designed to work with a wide range of medical devices and equipment – regardless of the manufacturer – and according to Capsule “increases patient visibility, improves collaboration between care teams, simplifies clinical workflows, and gives caregivers more time with patients.”

The company slots neatly into Philips’ current medical device and digital health range, which includes real-time patient monitoring, medical imaging, therapeutic devices, telehealth, health informatics and interoperability software.

“The acquisition of Capsule will further expand our patient care management offering,” said Roy Jakobs, who heads the connected care division at Philips, which will absorb Capsule and its 300 employees based in Massachusetts, US.

Thermo Fisher meanwhile has added to its stable in the last week with the $550 million takeover of Californian firm Mesa Biotech, which has developed a portable diagnostic device for infectious diseases.

That includes SARS-CoV-2 – the virus that causes COVID-19 – as well as influenza A and B, respiratory syncytial virus (RSV) and strep A. Mesa has emergency use authorisation from the FDA for the COVID-19 application and full approvals for the other diseases. Based on a rapid form of polymerase chain reaction (PCR) technology, the unit can deliver a result in 30 minutes.

Thermo is paying $450 million upfront for Mesa with another $100 million on offer if the device meets certain development and sales targets. The San Diego company has 500 employees and made revenues of around $45 million last year.

“The addition of Mesa Biotech’s easy-to-use, rapid PCR-based test is highly complementary to our existing offering and will further help us meet the continuing demand for COVID-related testing while we work to rapidly scale and develop point-of-care tests for other infectious diseases in the future,” said Mark Stevenson, Thermo’s chief operating officer.

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Biden appoints veteran Woodcock as interim FDA commissioner

Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden to replace outgoing Trump appointee Stephen Hahn.

Woodcock has most recently been working with the Operation Warp Speed coronavirus vaccine and drug project started by the Trump administration.

While this work will continue, the Operation Warp Speed name has been dropped and Woodcock will take a leading role at the agency she first joined in 1984.

Dr Janet Woodcock

Holding a Bachelor of Science in chemistry from Bucknell University and a Doctor of Medicine at Northwestern University Medical School, Woodcock first served as director of the division, covering new drugs at the FDA’s Center for Biologics Evaluation and Research (CBER).

She held several other roles at CBER before being named as director of the FDA’s Center for Drug Evaluation and Research in 1994 and staying in that role until 2005.

Between 2005 and 2008 she had several other roles at the FDA commissioner’s office, including deputy commissioner, chief medical officer and chief operating officer, before returning as head of CDER in 2008.

According to press reports, the Biden administration has not yet nominated a permanent commissioner.

In a tweet, Woodcock said that she will continue to recuse herself from work relating to the therapeutics developed by Operation Warp Speed, although this does not apply to vaccines.

She added that Julia Tierney, a 12-year veteran of the agency, has agreed to serve as acting chief of staff.

 

According to the New York Times, advisers to the Biden administration’s transition team, Woodcock is one of the candidates under consideration for the permanent position.

Insiders said that other candidates under review are principal deputy commissioner Dr Amy Abernethy and former agency official Dr Joshua Sharfstein, who is vice dean for public health practice and community engagement at Johns Hopkins University.

Hahn’s resignation is a formality as senior political appointees are expected to leave their roles when a new administration takes over.

In a farewell note to FDA staff, Hahn praised the organisation’s employees for their response to the coronavirus crisis.

He noted the scientific advances that have been achieved since the pandemic began, such as the authorisation of the first non-prescription over-the-counter coronavirus test, authorisation of the first antiviral agent and the first two FDA authorised COVID-19 vaccines.

But Hahn’s tenure was marked by miss-steps as the FDA came under political pressure from the previous administration, such as the Emergency Use Authorization for the drug hydroxychloroquine despite a lack of scientific evidence.

The post Biden appoints veteran Woodcock as interim FDA commissioner appeared first on .

Qiagen’s PCR Tests Demonstrate Effectiveness in Detecting Mutations in SARS-CoV-2 Virus

Shots:

  • Qiagen’s QIAstat-Dx and NeuMoDx tests remain accurate & effective in detecting SARS-CoV-2 infections
  • The company started cross-checking variants in May’2020 & assessed the tests against genetic mutations of the virus uploaded to the GISAID and GenBank public databases. Qiagen will continue to conduct assessments on a biweekly basis
  • Variants with potentially increased transmissibility include VUI 202012/01 (detected in the UK), 501Y.V2 (identified in South Africa), and B.1.1.28 P1 (discovered in Brazil)

Click here ­to­ read full press release/ article | Ref: PRNewswire| Image: Qiagen

The post Qiagen’s PCR Tests Demonstrate Effectiveness in Detecting Mutations in SARS-CoV-2 Virus first appeared on PharmaShots.

Yurts, Igloos and Pop-Up Domes: How Safe Is ‘Outside’ Restaurant Dining This Winter?

With the arrival of winter and the U.S. coronavirus outbreak in full swing, the restaurant industry — looking at losses of $235 billion in 2020 — is clinging to techniques for sustaining outdoor dining even through the cold and vagaries of a U.S. winter.

Yurts, greenhouses, igloos, tents and all kinds of partly open outdoor structures have popped up at restaurants around the country. Owners have turned to these as a lifeline to help fill some tables by offering the possibility at least of a safer dining experience.

“We’re trying to do everything we can to expand the outdoor dining season for as long as possible,” said Mike Whatley with the National Restaurant Association.

Dire times have forced the industry to find ways to survive. Whatley said more than 100,000 restaurants are either “completely closed or not open for business in any capacity.”

“It’s going to be a hard and tough winter,” Whatley said. “As you see outdoor dining not being feasible from a cold-weather perspective or, unfortunately, from a government regulations perspective, you are going to see more operators going out of business.”

In recent months, many cities and states have imposed a raft of restrictions on indoor dining, given the high risk of spreading the virus in these crowded settings.

Many have capped occupancy for dine-in restaurants. Some halted indoor dining altogether, including Michigan and Illinois. Others have gone even further. Los Angeles and Baltimore have halted indoor and outdoor dining. Only carryout is allowed.

Those who can serve customers outdoors, on patios or sidewalks, are coming up with creative adaptations that can make dining possible in the frigid depths of winter.

Embrace the ‘Yurtiness’

Washington state shut down indoor dining in mid-November and has kept that ban in place as coronavirus cases continue to surge.

On a blustery December evening, servers at the high-end Seattle restaurant Canlis huddled together in the parking lot, clad in flannel and puffy vests, while their boss Mark Canlis gave a pep talk ahead of a busy night.

“The hospitality out here is exactly the same as it is in there,” Canlis said, gesturing to his restaurant, which overlooks Lake Union. “But that looks really different, so try to invite them into the ‘yurtiness’ of what we are doing.”

Canlis has erected an elaborate yurt village in the parking lot next to his family’s storied restaurant.

It includes an outdoor fireplace and wood-paneled walkways winding between small pine trees and the circular tents. The assemblage of yurts, with their open window flaps, is the Canlis family’s best effort to keep fine dining alive during the pandemic and a typically long and wet Seattle winter (referred to locally as the “Big Dark”).

Arriving guests are greeted with a forehead thermometer to take their temperature and a cup of hot cider.

“It gives us an excuse to think differently,” Canlis said of the outdoor dining restrictions.

The yurts are meant to shield diners from the elements and from infectious airborne particles that might otherwise spread from table to table.

Dining inside such structures is not risk free: Guests could still catch the virus from a dining companion as they sit near each other, without masks, for a prolonged period. But Canlis said there is no easy way to determine whether every member of a dining group is from the same household.

“I’m not the governor or the CDC,” he said. “I’m assuming if you are there at the table, you’re taking your health into your own hands.”

New rules for outdoor dining structures in Washington require Canlis to consider issues such as how to ventilate the yurts properly and sanitize the expensive furniture.

“What is the square inch of yurt volume space? What is the size of the door and the windows? How many minutes will we allow the yurt to ‘breathe?’” Canlis said.

The structures get cleaned after each dining party finishes a meal and leaves; during the meal service the waiters enter and leave quickly, wearing N95 masks.

Igloos, Domes, Tents: Just How Safe Are They?

Another, more modern-looking take on outdoor dining involves transparent igloos and other domelike structures that have become popular with restaurant owners all over the country.

Tim Baker, who owns the Italian restaurant San Fermo in Seattle, had to order his igloos from Lithuania and assemble them with the help of his son.

His restaurant’s policy is that only two people are allowed in an igloo at a time, to cut down on the risk of those from different households gathering together.

“You’re completely enclosed in your own space with somebody in your own household. These domes protect you from all the people walking by on the sidewalk, and the server doesn’t go in with you,” he said.

Baker said he consulted with experts in airflow and decided to use an industrial hot air cannon after each party of diners leaves the igloo and before the next set enters — aiming to clear the air inside the structure of any lingering infectious particles.

“You fire this cannon up, and it just pushes the air through really aggressively,” quickly dispersing the particles, Baker said.

His restaurant’s igloos have become a big attraction.

“I’m particularly proud of anything that we can do to get people excited right now, because we need it,” he said. “We’re all getting crushed by this emotionally.”

Not all outdoor dining structures are created equally, said Richard Corsi, an air quality expert and dean of engineering and computer science at Portland State University in Oregon.

“There’s a wide spectrum,” Corsi said. “The safest that we’re talking about is no walls — a roof. And then the worst is fully enclosed — which is essentially an indoor tent — especially if it doesn’t have really good ventilation and good physical distancing.”

In fact, Corsi said, some outdoor dining structures that are enclosed and have lots of tables near each other end up being more dangerous than being indoors, because the ventilation is worse.

Dining that is truly outdoors, with no temporary shelter at all, is much safer because there are “higher air speeds, more dispersion and more mixing than indoors,” Corsi said, which means respiratory droplets harboring the virus don’t accumulate and are less concentrated when people are close to one another.

“If they have heaters, then you’re going to actually have pretty good ventilation,” Corsi said. “The air will rise up when it’s heated, and then cool air will come in.”

He said private “pods” or “domes” can be fairly safe if they are properly ventilated and cleaned between diners. That also assumes that everyone eating inside the structure lives together, so they have already been exposed to one another’s germs.

But Corsi said he is still not going out for a meal in one of the many new outdoor dining creations — “even though I know they’ve got a much lower risk” of spreading covid-19 than most indoor alternatives.

This story comes from NPR’s health reporting partnership with Kaiser Health News.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Plugging modular content into pharma’s omnichannel strategies

86% of respondents to a recent Veeva survey of pharma and biotech professionals said they are creating a greater volume of content now, compared to six months ago.  Yet while many pharma companies are creating more content than ever before, they also face increased pressure to quickly deliver highly personalised – and compliant – content to HCPs.

The proliferation of digital channels – and the COVID-promoted shift to remote working – have focused attention on speed and quality, so further work is needed to make the content creation process more efficient and less prone to error.

At a time when pharma marketing materials are often recreated and reapproved multiple times, and when regional teams can struggle to reuse assets across different regions, a dramatic shift in how to draft, review and distribute assets is needed. Modular content can provide a new foundation for creating relevant commercial content faster and at scale.

To assist executives in life sciences with scaling marketing assets in a virtual world Veeva has published a new eBook, Powering Omnichannel Strategies with Modular Content.

Acknowledging that life science companies are on a continuing journey with their use of modular marketing content, the eBook looks at how speed, personalisation and compliance will define the future of the content ecosystem – from creation all the way through to omnichannel delivery.

The publication provides:

  • A clear process for creating pharma modular content
  • A roadmap for bringing modular content to life
  • The key questions sales and marketing executives should ask of their content
  • An outline of the metrics for success that can be applied
  • A way to approach change management in modular content

Download Powering Omnichannel Strategies with Modular Content.

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Door to Door in Miami’s Little Havana to Build Trust in Testing, Vaccination


This story is part of a partnership that includes NPR, WLRN and KHN. It can be republished for free.

Little Havana is a neighborhood in Miami that, until the pandemic, was known for its active street life along Calle Ocho, including live music venues, ventanitas serving Cuban coffee and a historic park where men gather to play dominoes.

But during the pandemic, a group called Healthy Little Havana is zeroing in on this area with a very specific assignment: persuading residents to get a coronavirus test.

The nonprofit has lots of outreach experience. It helped with the 2020 census, for example, and because of the pandemic did most of that work by phone. But this new challenge, community leaders say, needs a face-to-face approach.

The group’s outreach workers have been heading out almost daily to walk the quiet residential streets, to persuade as many people as possible to get tested for covid-19. On a recent afternoon, a group of three — Elvis Mendes, María Elena González and Alejandro Díaz — knocked on door after door at a two-story apartment building. Many people here have jobs in the service industry, retail or construction; most of them aren’t home when visitors come calling.

Lisette Mejía did answer her door, holding a baby in her arms and flanked by two small children.

“Not everyone has easy access to the internet or the ability to look for appointments,” Mejía replied, after being asked why she hadn’t gotten a test. She added that she hasn’t had any symptoms, either.

The Healthy Little Havana team gave her some cotton masks and told her about pop-up testing planned for that weekend at an elementary school just a short walk away. They explained that people might lack symptoms but still have the virus.

Testing Is Still Too Difficult

The nonprofit organization is one of several receiving funding from the Health Foundation of South Florida. The foundation is spending $1.5 million on these outreach efforts, in part to help make coronavirus testing as accessible and convenient as possible.

A number of social and economic reasons make it difficult for some Miamians to get tested or treated, or isolate themselves if they are sick with covid. One big problem is that many people say they can’t afford to stay home when they’re sick.

“People usually rather go to work than actually treat themselves — because they have to pay rent, they have to pay school expenses, food,” said Mendes.

This part of Miami is home to many Cuban exiles, as well as people from all over Latin America. Some lack health insurance, while others are undocumented immigrants.

So Mendes and his team try to spread the word among residents here about programs like Ready Responders, a group of paramedics that now has foundation funding to give free coronavirus tests at home in areas like this one, regardless of immigration status.

“Our mission is for all these people to get tested — regardless if they have a symptom or not — so we can diminish the level of people getting covid-19,” Mendes said. According to the Centers for Disease Control and Prevention, people who are infected but presymptomatic or asymptomatic account for more than 50% of transmissions.

The Health Foundation of South Florida’s coronavirus-related grants have ranged from $35,000 to $160,000; other recipients include the South Florida chapter of the National Medical Association, Centro Campesino and the YMCA of South Florida.

The foundation is focusing on low-income neighborhoods where some residents might not have access to a car or be able to afford a coronavirus test at a pharmacy. Their focus includes residential areas near agriculture work sites. In Miami-Dade County, the foundation is working with county officials directly to increase testing. In neighboring Broward County, the foundation is collaborating with public housing authorities to bring more testing into people’s homes.

Soothing Fears, Offering Options in Spanish

It’s time-consuming to go door to door, but worthwhile: Residents respond when outreach teams speak their language and make a personal connection.

Little Havana resident Gloria Carvajal told the outreach group that she felt anxious about whether the PCR test is painful.

“What about that stick they put all the way up?” Carvajal asked, laughing nervously.

González jumped in to reassure her it’s not so bad: “I’ve done it many times, because obviously we’re out and about in public and so we have to get the test done.”

Another outreach effort is happening at Faith Community Baptist Church in Miami. The church hosted a day of free testing back in October, with help from the foundation.

“You know us. You know who we are,” said pastor Richard Dunn II. “You know we wouldn’t allow anybody to do anything to hurt you.”

Dunn spoke recently in nearby Liberty City, a historically Black neighborhood, at an outdoor memorial service for Black residents who have died of covid. To convey the magnitude of the community’s losses, hundreds of white plastic tombstones were set up behind the podium. They filled an entire field in the park.

“Thousands upon thousands have died, and so we’re saying to the Lord here today, we’re not going to let their deaths be in vain,” Dunn said.

Dunn is also helping with a newly launched effort to build trust in the covid vaccines among Black residents, by participating in online meetings during which Black church members can hear directly from Black medical experts. The message of the meetings is that the vaccines are safe and vital.

“It’s taken over 300,000 lives in the United States of America,” Dunn said at the end of the meeting. “And I believe to do nothing would be more of a tragedy than to at least try to do something to prevent it and to stop the spreading of the coronavirus.”

Churches will play a big role in the ongoing outreach efforts, and Dunn is committed to doing his part. He knows covid is an extremely contagious and serious disease — this past summer, he caught it himself.

This story comes from a reporting partnership that includes WLRN, NPR and Kaiser Health News.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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After a Decade of Lobbying, ALS Patients Gain Faster Access to Disability Payments

Anita Baron first noticed something was wrong in August 2018, when she began to drool. Her dentist chalked it up to a problem with her jaw. Then her speech became slurred. She managed to keep her company, which offers financing to small businesses, going, but work became increasingly difficult as her speech worsened. Finally, nine months, four neurologists and countless tests later, Baron, now 66, got a diagnosis: amyotrophic lateral sclerosis.

ALS, often called Lou Gehrig’s disease after the New York Yankees first baseman who died of it in 1941, destroys motor neurons, causing people to lose control of their limbs, their speech and, ultimately, their ability to breathe. It’s usually fatal in two to five years.

People with ALS often must quit their jobs and sometimes their spouses do, too, to provide care, leaving families in financial distress. A decade-long campaign by advocates highlighting this predicament notched a victory last month when Congress passed a bill opening key support programs earlier for ALS patients.

In late December, then-President Donald Trump signed the bill into law. It eliminates for ALS patients the required five-month waiting period to begin receiving benefits under the Social Security Disability Insurance program, which replaces at least part of a disabled worker’s income. Gaining SSDI also gives these patients immediate access to Medicare health coverage.

Advocacy groups note that the Social Security Administration still will need to set up procedures for implementing the law, before patients will see the benefits.

The Muscular Dystrophy Association, an umbrella organization for people with 43 neuromuscular conditions, partnered with other ALS groups to support the bill to eliminate the SSDI waiting period.

“We’re hopeful that it can serve as a model for other conditions that may be similarly situated,” said Brittany Johnson Hernandez, senior director of policy and advocacy at MDA.

In the weeks leading up to the passage of the bill, Sen. Mike Lee (R-Utah) sought to broaden the scope of the legislation to include other conditions. He pledged to continue to work on legislation to eliminate the SSDI waiting period for additional diseases that meet certain criteria, including those with no known cure and a life expectancy of less than five years.

Eliminating the SSDI waiting period has been a top priority for ALS advocates. There is no simple, single test or scan to confirm that someone has ALS, though symptoms can escalate rapidly. By the time people finally get the diagnosis, they are often already seriously disabled and unable to work. Waiting five months longer for financial aid can be a burden, according to patients and families.

“Five months may seem like a short period of time, but for someone with ALS it matters,” said Danielle Carnival, CEO of I Am ALS, an advocacy group. “It’s a huge win and will make a huge difference for people right away.”

Eligibility for SSDI benefits generally requires people to have worked for about a quarter of their adult lives at jobs through which they paid Social Security taxes. Benefits are based on lifetime earnings; the average monthly SSDI benefit was $1,259 in June 2020, according to the Social Security Administration. (The average retirement benefit was $1,514 that month.)

The SSDI waiting period was intended to make sure the program served only people expected to have claims that would last at least a year, said Ted Norwood, chief legal officer at Integrated Benefits Inc. in Jefferson City, Missouri, who represents SSDI applicants. But it isn’t necessary, he added, because disability rules now require that people have a condition that will keep them out of work at least a year or result in death.

“The five-month waiting period serves no purpose as far as weeding out cases,” Norwood said.

Existing federal law also made special health provisions for people with ALS and end-stage renal disease. Most people with disabilities must wait two years to be eligible for Medicare, but people with either of those two diseases can qualify sooner. ALS patients are eligible as soon as SSDI benefits start.

The new law could have made a big difference for Baron, who lives in Pikesville, Maryland. She and her husband, who works part time at a funeral parlor, didn’t have comprehensive health insurance when she got sick. They were enrolled only in a supplemental medical plan that paid out limited cash benefits.

By the time she was diagnosed and her SSDI and Medicare came through, Baron and her husband had maxed out their credit cards, raided $10,000 from their IRA and gone to their family for money. They were $13,000 in debt. They sold their house and moved into a condo to save on expenses.

“It is imperative that as [people] become more and more debilitated and cannot work, that they have immediate access to SSDI,” Baron said.

Like Sen. Lee, some patient advocates say the accommodations on disability benefits and Medicare made for patients with ALS should be extended to others with similarly intractable conditions.

The Social Security Administration has identified 242 conditions that meet the agency’s standards for qualifying for disability benefits and are fast-tracked for benefit approval.

Once approved, people with these conditions still must wait five months before they receive any money. Now, under the new law, people with ALS can skip the waiting period, though no one else on the “compassionate allowances” list can.

Breast cancer advocates are hoping for similar accommodations for people with metastatic breast cancer. Legislation introduced in the House and Senate in 2019 would have eliminated the SSDI waiting period for this group, but it did not pass.

Tackling the problem one condition at a time doesn’t make sense, others argue.

“Can you imagine, one by one, people with these conditions trying to find people in the House and in the Senate to champion the bill?” said Carol Harnett, president of the Council for Disability Awareness, which represents disability insurers.

Deb McQueen-Quinn thinks it would be good if the new law sets a precedent for eliminating the SSDI waiting period. At 55, McQueen-Quinn has lived with ALS since 2009, far longer than most.

A former convenience store manager, she uses a wheelchair full time now. She knows all too well the toll of the disease. ALS runs in her family, and she’s watched several family members, including her sister, brother and a cousin die of it.

Her sister, a former quality control engineer, was diagnosed in 2006 and died the following year, a week before she would have received her first SSDI payment.

McQueen-Quinn, who lives in Wellsville, New York, with her husband, has two children in their 30s. Her son, 33, carries the familial genetic mutation that leads to ALS. So far he hasn’t developed symptoms. But it’s for people like her son and other family members that she fought for the new law.

“Now that we’ve set the precedent, I’m sure you’ll see a lot of other diseases go after this,” she said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Haemonetics to Acquire Cardiva Medical for ~$510M

Shots:

  • Cardiva to receive $475M up front and up to an additional ~$35M in contingent consideration based on sales growth. The transaction is expected to be completed in Q1’21
  • The acquisition expands Haemonetics’ blood transfusion and loss management offerings and enhance its penetration into the large and growing interventional cardiology and electrophysiology markets
  • Cardiva’s portfolio includes two catheter-based vascular access site closure devices used to help seal up access sites following minimally invasive interventions and diagnostic procedures. Both devices employ a collapsible disc in different sizes to deliver a collagen patch to achieve hemostasis

Click here ­to­ read full press release/ article | Ref: PRNewswire| Image: Mass Device

The post Haemonetics to Acquire Cardiva Medical for ~$510M first appeared on PharmaShots.

There are two new Covid-fighting drugs I haven’t heard much about – is it because they are unpronounceable? | Adrian Chiles

Generic medicine names can sound like random collections of syllables. But there is a method to it

It is a couple of weeks since the announcement of two important new drugs in the treatment of Covid. They have not really been mentioned since, especially in the broadcast media. I think I know why: their names are a right mouthful and have been made a meal of several times by people like me. The prime minister, alas, fumbled them in the first place, but on this occasion I don’t see we can blame him. Even with a bit of practice and a steady run-up, tocilizumab and sarilumab remain hard to say and next to impossible to remember.

I have long wondered where they conjure these names up. It is tricky enough, especially for older people, to get your head around what you’re taking and when and what for, without dealing with all these unmemorable, apparently random collections of syllables. I have been taking something for reflux for years and I still forget whether it’s opremazole or omeprazole.

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Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Shots:

  • The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with symptomatic CHF and LVEF less than 45%, following a worsening HF event
  • The study met the primary efficacy objective based on a time-to-event analysis & showed a 4.2% reduction in annualized absolute risk. The 1EPs is time to the first event of CV death or hospitalization for HF @median follow-up of 11 mos.
  • Verquvo is the first soluble guanylate cyclase stimulator, approved to treat HF

Click here ­to­ read full press release/ article | Ref: Business Wire| Image: Financial Times

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Merck KGaA and GSK’s Bintrafusp Alfa Fails to Meet its Co-Primary Endpoints in Lung Cancer Study

Shots:

  • Merck KgaA provides an update on its P-III [email protected] Lung 037 study and the extensive [email protected] clinical trial program assessing bintrafusp alfa for patients with BTC and cervical cancer
  • Based on the IDMC’s recommendation, Merck will discontinue the [email protected] Lung 037 study as it fails to meet its co-1EPs, specifically PFS. The ongoing clinical trial [email protected] Lung 037 includes 1L treatment of patients with stage IV NSCLS having PD-L1 expression
  • The company will further evaluate bintrafusp alfa in other studies. GSK has high hopes with the drug as it has paid $4.2B+ in the collaboration signed in 2019

Click here ­to­ read full press release/ article | Ref: Merck KgaA | Image: GMP News

The post Merck KGaA and GSK’s Bintrafusp Alfa Fails to Meet its Co-Primary Endpoints in Lung Cancer Study first appeared on PharmaShots.

11,900 COVID-19 vaccine doses ruined en route to Michigan

The majority of 21 shipments of the Moderna COVID-19 vaccine on Sunday were spoiled en route to Michigan, likely delaying the state’s vaccination efforts this week, the Department of Health and Human Services said Tuesday.

The vaccine’s distributor, McKesson Corp., notified the state that the majority of the 11,900 doses in the shipments got too cold and are now unusable. The Moderna vaccine is stored and shipped at roughly 4 degrees below zero Fahrenheit. Once on site, the vaccine can be kept at temperatures between 36 degrees and 77 degrees Fahrenheit for up to six hours before being administered to a patient.

The vaccine shipments are equipped with a temperature monitoring device to ensure safe transport. The reason for the temperature drop is currently unknown and under investigation by McKesson, the state said in a press release.

Most of the nearly 12,000 doses were resent on Monday night, the state said, with the rest shipped Tuesday. An additional six shipments were held back to ensure there were no temperature issues, which may delay vaccinations at an additional six vaccine sites this week, MHHS said in the release.

“We are committed to accelerating vaccine delivery as we work to reach our goal of vaccinating 70 percent of Michiganders over age 16 as quickly as possible with the safe and effective COVID-19 vaccine,” Dr. Joneigh Khaldun, the state’s chief medical executive and chief deputy for health, said in a statement. “Although it is unfortunate that this vaccine will not be able to be used, we are pleased that the safeguards put into place to ensure the integrity of the vaccine worked. This is the first report of vaccine potentially being compromised during shipment in Michigan and we are working quickly with the distributor to have replacement vaccine shipped out.”

Nearly 1.05 million doses of the COVID-19 vaccine from Pfizer and Moderna have been distributed in Michigan since last month, but fewer than half that figure have been administered to patients. Most counties in Michigan are rushing to vaccinate teachers as Gov. Gretchen Whitmer is pushing for the return to full in-class learning at schools across the state on March 1.

Those aged 65 and older are also qualified to receive the vaccine across Michigan.

OSH practitioners invited to a webinar on substitution of dangerous substances at work

21/01/2021

© EU-OSHA / Helen Xenikak

Practitioners from enterprises dealing with chemicals and dangerous substances, labour inspectorates, environmental authorities and academia from different disciplines, are encouraged to enrol in a training organised by NIVA education on Alternative…

What Causes ‘Stress Belly’ and What Can You Do About It?

If you’ve been stressed lately and you’ve noticed your pants aren’t fitting quite the same, you may be wondering if they’re related.

“There are many reasons for weight gain including increased caloric intake, decreased physical activity, and stress,” says Cody Braun, CPT, Assistant Manager of Fitness at Beachbody.

“Our bodies are complex machines, which makes it hard to find the root cause of weight gain for each individual. The best we can do is assess our environment and find where we can make improvements,” he explains.

But there’s no denying that we’re feeling excess stress right now.

You’re likely aware if you’ve been eating more than usual, even if you’re not sure why you stress eat.

But weight gain isn’t always as simple as that.

Stress is associated with weight gain, and you may be dealing with a case of stress belly.

Tired young businessman working at home

What Is “Stress Belly”?

“‘Stress belly’ usually refers to that weight gain around your midsection that occurs when there has been a change in your daily stress level, emotions, and life changes,” says Emily Tills, M.S., R.D.N., C.D.N.

“Although this weight gain usually feels like it is from excess eating, which is a big contributing factor to stress belly, it also has to do with our body’s physiological response to stress,” she adds.

Dana Hunnes, Ph.D., M.P.H., R.D., a senior dietitian at the Ronald Reagan UCLA Medical Center, adds that not all stress is likely to cause stress belly.

Short-term stressors are unlikely to lead to weight accumulating, whereas excessive and chronic stressors (like working a toxic job) can turn on and keep on a hormonal cascade that promotes weight gain.

Ultimately, there are two hormones at play here: cortisol and insulin.

That’s not to say that cortisol is a bad thing. We need some of it. Though cortisol is commonly known as the “stress hormone,” it also helps us get up and go.

A cortisol spike in the mid-morning, called the cortisol awakening response, helps us be alert enough to tackle that to-do list, for example.

The problem comes when there’s chronic stress. Your cortisol levels are constantly high and the body shuts down other bodily processes until the “stressor” is resolved.

But in this case the “stressor” doesn’t go away and your health is impacted.

Stressed woman in bed with chocolate and wine

The Stress Response and Weight Gain

When you need to fight or run to survive — how our ancestors’ stress happened — our bodies pump out cortisol.

This hormone does several things that help you survive: It’s a powerful anti-inflammatory agent (to help you keep running even if you break your foot). It turns off non-vital body functions (you don’t need to digest, you need to run).

And it mobilizes glucose in order to get your muscles the fuel they need.

What’s the problem with that?

Our bodies are primed to run or fight — but we don’t. In fact, many times we just sit at our desks.

So our bodies call for more fuel to escape, but as Tills points out, “the body is already in a fed state and actually suppresses digestion as a response to stress, therefore causing the body to store this excess energy as fat, causing stress belly.”

Hunnes explains that this is because the combination of cortisol and insulin creates lipoprotein lipase, “which is an enzyme that tends to increase the amount of fat we store in our midsections.”

These effects of cortisol are so hard to escape because cortisol is released for hours after you experience something stressful.

And the amount of stressors we experience daily, many researchers hypothesize, is far higher than that experienced by our ancestors.

Other factors that contribute to “stress belly”

Hormonal issues or transitions can also cause fat to accumulate around your belly.

For women, this often means fat gain in the abdomen during perimenopause or menopause.

Lower thyroid function, increased cortisol production, and estrogen out of balance with progesterone all tend to happen as women age and may contribute to gaining belly fat.

Though fat storage is the primary driver of “stress belly,” there may be digestive problems at play, too.

“It is possible that digestive problems can add to a small fraction of weight gain,” Braun says. “If you notice bloating or other digestive problems it is important to reassess your nutrition and your stress levels.”

You may have stress constipation that’s making weight gain from stress look bigger.

Although more human research is needed, preliminary animal research shows that psychological stress can also negatively impact the balance of bacteria in the gut, thus potentially leading to weight gain.

Couple eating pizza on the sofa in their living room

What Are The Risks of Having Stress Belly Fat?

“Cortisol has been linked to the storage of visceral fat,” Braun points out — and this is where the health risks come in.

Unlike subcutaneous fat, the kind that accumulates under your skin (you can pinch it), visceral fat forms around your organs in your abdomen.

Subcutaneous fat storage is more individual: Some people tend to gain weight around their midsections, while others may accumulate it on their hips, thighs, and butt.

“Everyone is predisposed to store fat differently, but visceral fat inside the abdomen can be more detrimental to health when you accumulate too much,” Braun explains.

And there are risks to having visceral belly fat even if you’re at a normal weight.

Women with higher abdominal obesity — fat gain in the abdomen specifically — had a higher risk of having asthma and their asthma was more severe than women with smaller waist measurements, one study found.

The risk was still higher for those with waist measurements pointing to visceral fat even if their weight was normal.

The potential dangers of visceral fat aren’t simply because it’s found around the internal organs.

Visceral fat is actually hormonally active, which means it can interfere with many of our bodies’ natural processes.

This type of fat’s effect on circulating hormones is one of the reasons why it’s associated with so many health conditions.

The more visceral fat you have, the less of a compound called adiponectin you have circulating in your body, researchers have found.

Low levels of this hormone are associated with type 2 diabetes, elevated glucose levelshigh blood pressure (hypertension), and even certain types of cancer.

Getting specific about the type of fat matters. (Even though you can gain subcutaneous fat around your stomach, it’s visceral fat that’s linked to diabetes risk.)