Clinical trials going digital. JAMA return-to-play guidance. Would a COVID-19 vaccine produce larger health or economic benefits? Pros and cons of telemedicine. Are we there yet? A review of 4 value-based care programs.
A machine learning model… read more
By ROSEMARIE DAY and NIKO LEHMAN-WHITE One of the most important responsibilities of the American government is to protect its citizens from harmful industry practices, from lead poisoning to dangerous pharmaceuticals to financial meltdowns. Its record is far from perfect, but government regulators usually act… Read More »Election Issue Spotlight: “Junk” Insurance Makes a Pandemic Even Worse
The great opportunities of cell and gene therapy (CGT) are self-evident. Life sciences businesses can find a new purpose in a generation of products that could treat or cure millions. But the CGT industry is early on in its learning curve. Therapies currently priced… Read More »Automation is key in cell and gene therapy manufacturing
Medical research charities are urging the UK government to financially support charity-funded research to protect the UK’s position as a global leader in science. The charities, including the British Heart Foundation and Cancer Research UK (CRUK), propose the government introduces a Life Sciences-Charity Partnership Fund,… Read More »COVID-19 is threatening the UK’s medical research prowess, say charities
This brief describes health insurance subsidies available through the Affordable Care Act’s marketplaces, including premium subsidies that would be provided in the form of tax credits, as well as other subsidies that would lower cost sharing to eligible Americans. It provides details on who is… Read More »Explaining Health Care Reform: Questions About Health Insurance Subsidies
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.
These prescription-only drugs will be available at all retail medical outlets and hospital pharmacies across the country, from November 1, 2020, FDC said in a BSE filing.
In consultation with other federal partners, FDA has developed a list of drug and biological product essential medicines, drug, biological product, and device medical countermeasures, and critical inputs, as required by Executive Order 13944. FDA welcomes public comment on this list.
The United States on Thursday hit a new record for a single-day increase in coronavirus infections with nearly 90,000 new cases reported, according to data collected from Johns Hopkins University. On Thursday, the U.S. had 88,521 new…
During the first COVID-19 surge of the spring, the mantra was “Flatten to curve”—to buy time, using every tool available. Seven months later, it’s possible to measure what that time has bought: The death rate for COVID-19 has fallen dramatically. Hospitals in most places are… Read More »The Best Time to Get COVID-19
Shots: The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count Results: The PRIMA study improved PFS for patients… Read More »GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer
Novo Nordisk’s Saxenda has been recommended by NICE as a treatment for obesity, ending a 10-year drought in new drug therapies for weight management. The cost-effectiveness agency for England and Wales has recommended Saxenda (liraglutide) as a treatment option for people with a body mass… Read More »Price cut leads NICE to back Novo Nordisk’s obesity drug Saxenda
Liquid biopsy company ANGLE has raised £20m through a conditional placing on the London Stock Exchange which will be used to expand commercial opportunities. ANGLE’s Parsortix system detects and captures circulating tumour cells (CTCs) in blood for subsequent analysis. The company believes there is huge… Read More »ANGLE raises £20m, eyes opportunity in immunotherapy trials
Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 billion in deposits for the shot. The figure was revealed by CEO Stéphane Bancel in Moderna’s third-quarter results call… Read More »Moderna banks $1.1bn in COVID-19 vaccine deposits, signs Japan supply deal
AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis
Shots: The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1,… Read More »AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis
Since entering the pharmaceutical industry as a graduate trainee in the late 1990s, Asad Mohsin Ali’s career has taken him across the business from Novartis, MSD and Tesaro, before joining global biopharma Ipsen. He tells us how the company has responded to COVID and how… Read More »Ipsen’s UK MD on adapting business to COVID-19
At the top of Dr. Hiral Tipirneni’s to-do list if she wins her congressional race: work with other elected officials to encourage mask mandates and to beef up COVID-19 testing and contact tracing. Those choices are backed up by science, said Tipirneni, an emergency room… Read More »‘It’s Science, Stupid’: A School Subject Emerges as a Hot-Button Political Issue
KHN chief Washington correspondent Julie Rovner discussed the current surge in COVID-19 cases, health policy in the election and the Affordable Care Act case before the Supreme Court with NPR’s “All Things Considered” on Sunday and WBUR’s “On Point.” Click here to hear Rovner on… Read More »KHN on the Air This Week
Democrats are favored to win both chambers of Congress after years of campaign-trail promises about health care. But with a pandemic, a more conservative Supreme Court and lingering disagreements between progressives and moderates, it could be difficult for Democrats to turn those promises into law.… Read More »If They Sweep on Election Day, Dems Still Face a Challenge Meeting Health Promises
If they’ve been listening to President Donald Trump, seniors may be expecting a $200 debit card in the mail any day now to help them pay for prescription drugs. He promised as much this month, saying his administration soon will mail the drug cards to… Read More »A $200 Debit Card Won’t Do Much for Seniors’ Drug Costs
Nursing homes, small physician offices and rural clinics are being left behind in the rush for N95 masks and other protective gear, exposing some of the country’s most vulnerable populations and their caregivers to COVID-19 while larger, wealthier health care facilities build equipment stockpiles. Take… Read More »Why State Mask Stockpiling Orders Are Hurting Nursing Homes, Small Providers
In a tweet to his 78,000 followers Sunday, U.S. Rep. Harley Rouda, a Democrat from Orange County, California, described his Republican opponent Michelle Steel’s attendance at an indoor fundraiser without a mask as “sickening.” Democratic U.S. Rep. Gil Cisneros also blasted his Republican opponent, Young… Read More »Democrats Link GOP Challengers to Trump’s COVID Record, Efforts to Undo Obamacare
A big thanks to our readers who participated in our second annual KHN Halloween Haiku Contest. Your entries — like our health care system — ranged from eerie and haunting to downright spooky. And, based on a review by our expert panel of judges, here’s… Read More »Haiku Winner Unmasked! Read If You Dare
Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s KEYTRUDA® (pembrolizumab) in Patients with Various Cancers
Shots: Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors In preclinical studies,… Read More »Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s KEYTRUDA® (pembrolizumab) in Patients with Various Cancers
Findings come from new research funded by Cancer Research UK and NIHR
Drug significantly eliminated oral corticosteroid (OCS) in OCS-dependent asthma patients
The UK BIA Antibody Taskforce is set to take combinations into further development as a cocktail
Shots: It is based on P-lllb PONENTE trial assessing Fasenra (benralizumab, 30mg) in adult patients with severe Asthma on high-dose ICS + LABA and long-term use of OCS therapy with or without additional asthma controller. This study included approx. 600 patients in EU, North America,… Read More »AstraZenca Reports Results of Fasenra (benralizumab) in P-lllb PONENTE Trial for Asthma
30/10/2020 Free online training for psychosocial risk assessment Psychosocial risk assessment (PRA) is a legal requirement and a complicated process faced by companies that want to offer their employees optimal working conditions. A free online training offered through PsyHealth worXs! has been specifically…
The company said that by December, it expected to have produced enough drug to treat 2 million patients and that it was studying an inhaled form of the drug that could expand its use to outpatients.
Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the Treatment of Unresectable Hepatocellular Carcinoma
Shots: The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a… Read More »Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the Treatment of Unresectable Hepatocellular Carcinoma
We have begun a Health Technology Assessment process for all products currently subsidised under the Continuous Glucose Monitoring (CGM) Initiative.
The Oncology Care Model is slated to end soon. Specifically, the last set of six-month episodes would initiate no later than December 31, 2020 and thus all episodes will be completed in June 30, 2021. Nevertheless, CMS is proposing a successor to the Oncology Care… Read More »The Oncology Care Model is dead. Long Live the Oncology Care First Model.
The post Isolation heightening teens’ image anxieties appeared first on Healthy Debate.
U.S. reaches $375 million deal for Lilly COVID-19 antibody drug Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Eli Lilly & Co. says it will provide 300,000 doses of bamlanivimab, its experimental COVID-19 antibody drug, to the U.S. government for $375 million if the… Read More »U.S. reaches $375 million deal for Lilly COVID-19 antibody drug
Medicare, Medicaid will cover costs of future COVID-19 vaccine under new policy Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 In an official announcement on Wednesday, CMS said Medicare beneficiaries will receive any FDA-approved coronavirus vaccine for free. The new policy calls for providers… Read More »Medicare, Medicaid will cover costs of future COVID-19 vaccine under new policy
FDA approves fewer generics in FY2020, ending record streak Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 After 4 consecutive years of posting record numbers of abbreviated new drug application (ANDA) approvals, FDA approved 22% fewer generic drugs in the 2020 fiscal year (FY2020)… Read More »FDA approves fewer generics in FY2020, ending record streak
Opinion: I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective. Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, says to encourage trust in any COVID-19… Read More »Opinion: I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective.
Oregon, Washington, and Nevada join California to vet COVID-19 vaccine Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 The states of Washington, Nevada, and Oregon said Tuesday they will work with California to evaluate any COVID-19 vaccine before offering it to the public. The… Read More »Oregon, Washington, and Nevada join California to vet COVID-19 vaccine
Stop & Shop offers free virtual education series for National Diabetes Awareness Month Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Stop & Shop will host a month-long webinar series highlighting National Diabetes Awareness Month this November. The series is designed to educate participants,… Read More »Stop & Shop offers free virtual education series for National Diabetes Awareness Month
Medical crowdfunding in U.S. is much likelier to be for routine care Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 New research indicates that medical crowdfunding efforts in the United States are more likely to be for routine medical care compared with other countries.… Read More »Medical crowdfunding in U.S. is much likelier to be for routine care
CVS pharmacies in Philadelphia closed early Wednesday after 20 stores damaged during looting Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Civil unrest in Philadelphia, marked by protests and looting, prompted CVS Pharmacies to lock up local stores early on Tuesday and Wednesday. With… Read More »CVS pharmacies in Philadelphia closed early Wednesday after 20 stores damaged during looting
Kroger Health launches COVID-19 rapid antibody testing at pharmacy locations Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Kroger Health announced Wednesday the launch of rapid antibody COVID-19 testing at its California (Ralphs) and Michigan pharmacies. According to the company, the rapid antibody testing… Read More »Kroger Health launches COVID-19 rapid antibody testing at pharmacy locations
Somatic mutations in UBA1 and severe adult-onset autoinflammatory disease Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 A study partially funded by NIH examined differences in ubiquitin-related genes, which play a role in autoinflammatory disease and may characterize previously unknown conditions. The research involved… Read More »Somatic mutations in UBA1 and severe adult-onset autoinflammatory disease
Ticagrelor vs. clopidogrel and adverse events in patients with acute coronary syndrome undergoing PCI
Ticagrelor vs. clopidogrel and adverse events in patients with acute coronary syndrome undergoing PCI Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Ticagrelor is the recommended P2Y12 platelet inhibitor for patients with acute coronary syndrome (ACS), but because this indication is largely based on… Read More »Ticagrelor vs. clopidogrel and adverse events in patients with acute coronary syndrome undergoing PCI
Sunstar Americas Inc. issues recall of chlorhexidine gluconate oral rinse USP, 0.12% due to microbial contamination
Sunstar Americas Inc. issues recall of chlorhexidine gluconate oral rinse USP, 0.12% due to microbial contamination Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Sunstar Americas, Inc. (SAI) announced a voluntary, nationwide recall of certain chlorhexidine gluconate oral rinse (Paroex), USP, 0.12% products because… Read More »Sunstar Americas Inc. issues recall of chlorhexidine gluconate oral rinse USP, 0.12% due to microbial contamination
After alarming data showed that 865,000 women dropped of the workforce in September alone, new data from Doximity showed the pay gap between male and female doctors is widening.
In the scheme for bulk drugs the government has replaced the criteria of ‘minimum threshold’ investment with ‘committed’ investment by the selected applicant.
What You Should Know: – Epic Systems announces that more than 90 health systems across nine counties are expected to go-live on Epic, marking this fall as the busiest install season in Epic’s 41+ year history. – Healthcare organizations in Australia, Belgium, Canada, Finland, Saudi… Read More »Epic Expects More Than 90 Health Systems to Go-Live on EHR This Fall
29/09/2020 Virtual campaign partnership meeting: Healthy Workplaces Lighten the Load 2020-2022 Ahead of the launch of the 2020-2022 campaign — Healthy Workplaces Lighten the Load — representatives of European and international enterprises and organisations joined EU-OSHA for a virtual campaign partnership meeting. They learned about… Read More »Virtual campaign partnership meeting: Healthy Workplaces Lighten the Load 2020-2022
30/10/2020 Lighten the load calls for partners to address MSDs in the workplace EU-OSHA presented its latest campaign partnership offer at a virtual meeting last 29 September, urging companies and organisations from across Europe to sign up to the 2020-2022 Healthy Workplaces Lighten the Load… Read More »Lighten the load calls for partners to address MSDs in the workplace
Shirley Ryan AbilityLab in Chicago is learning new approaches to caring for patients who face long, difficult recoveries from the coronavirus.
The food industry will face significant challenges in the future. However, an EU-funded project has created an international research network capable of confronting environmental threats as well as consumer demand for traceable, ethical ingredients.
House Speaker Nancy Pelosi says remaining obstacles to an agreement include more than half a dozen big-ticket items, including a testing plan, aid to state and local governments, funding for schools, jobless benefits and a GOP-sought shield against coronavirus-related lawsuits.
The doctor will Zoom you now: Pharma execs talk ins and outs of telehealth bbulik Thu, 10/29/2020 – 19:17
After a launching their social determinants of health partnership in Nebraska over the summer, technology company Unite Us and the Nebraska Health Information Initiative have plans to expand it to six more states.
Without the ability to aggregate representative, structured data in real-time for analysis, novel situations like the COVID-19 pandemic leave organizations and professional associations struggling to develop evidence-based guidance rapidly
The U.S. Centers for Medicare & Medicaid Services (CMS) issued its final 2021 home health payment rule Thursday. In doing so, it changed very little from what it first proposed in June. The final rule adds an estimated $390 million home health payment boost for… Read More »[Updated] CMS Finalizes 1.9% Home Health Rate Increase for 2021, Keeps PDGM’s Behavioral Adjustment
Hundreds of thousands of dollars’ worth of monthly personal protective equipment (PPE) costs. Nationwide lockdowns of assisted living communities. Continued restrictions on elective surgeries in most markets. These remain just a few of the major pain points that Encompass Health Corp. (NYSE: EHC) and its… Read More »Encompass Health Gaining Ground with ACOs, But Still Facing Assisted Living ‘Lockdowns’
Ascension Rx—the newly launched brand for its national pharmacy—offers specialty medication packaging and delivery, infusion therapy and medication management, including financial aid coordination.
The COVID-19 pandemic has brought the home healthcare industry to a crossroads. More older adults are comfortable with mobile devices and smart technologies that help them safely age in place. Some individuals may be seeking to avoid full-time care in a congregate care setting due to… Read More »Why Home Healthcare Needs More Technology and Training
Overnight Health Care: Winter COVID-19 wave poses threat to nation’s hospitals | Two people who attended Trump’s North Carolina rally test positive | Documents show ‘political’ nature of Trump coronavirus ad campaign, lawmakers say
Welcome to Thursday’s Overnight Health Care.The spike in COVID-19 cases is putting a massive strain on the nation’s hospitals as the country reached a record number of new infections this week. Meanwhile, House Democrats released documents showing…
The FBI, along with two other federal agencies, released a joint advisory warning that the U.S. healthcare system is the target of a concerted ransomware attack. Cybersecurity experts are urging healthcare organizations to shore up their IT networks and remain vigilant.
Providers will be able to use telehealth if it’s outlined in a patient’s care plan and tied to a specific goal to improve treatment. CMS bumped pay for home health by 1.9%, or about $390 million.
Community health centers warned that they will lose out on 340B discounts if the program goes into effect.
The U.S. on Thursday set a new weekly record for COVID-19 infections with more than 500,000, according to data from the COVID Tracking project, as a wave of cases builds ahead of winter.Twenty-five states have set a new record for cases in…
Researchers have found that a more intensive, less frequent drug regimen with currently available therapeutics could cure the infection that causes Chagas disease.
Universal Health Services’ net income was $241.3 million in the quarter ended Sept. 30, compared with $97.2 million in the prior-year period.
The brainchild of Comcast NBCUniversal and Independence Health Group — Quil — has set its sights on solidifying its place in the home. The company recently unveiled plans to launch Quil Assure, a sensor-based technology platform that aims to keep seniors and their informal caregivers… Read More »Comcast NBCUniversal, Independence Health Group Offshoot Quil Launches Aging In Place Platform
The payer reported it spent $35 million on COVID-19 care in the quarter. But as cases reach new heights in the U.S., it expects members to again defer care as virus costs are likely to increase.
Visits to emergency departments (ED) dropped by 42% in the early months of COVID-19, according to the CDC. In pre-pandemic times, this might have been a positive sign. Two-thirds of ED visits are thought to be avoidable, with emergency care used as a safety net… Read More »How health plans can reduce ED visits and readmissions post-pandemic
Nota: esta calculadora refleja las primas para 2021. Esta calculadora ilustra las primas (el costo mensual de su seguro) y subsidios para las personas que compran seguro médico por su propia cuenta en el nuevo mercado de seguros de salud (o de intercambio) creado por… Read More »Calculadora del Mercado de Seguros Médicos
Scrutiny of drug prices will continue whether Trump or Biden wins. But pharma can take steps to address critics and cut costs before they reach a crisis point, according to a panel of industry experts.
For 2021, the average Medicare beneficiary has access to 33 Medicare Advantage plans, the largest number of options available in the last decade, and can choose from plans offered by eight firms. Among the majority of Medicare Advantage plans that cover prescription drugs, 54 percent… Read More »Medicare Advantage 2021 Spotlight: First Look
When there are challenges in any industry, the organizations that hurdle them quickly and efficiently end up gaining an advantage. Amedisys Inc. (Nasdaq:AMED) feels like it has done that. After a census bounce-back from COVID-19, a successful transition to the Patient-Driven Groupings Model (PDGM) and… Read More »Amedisys Makes Progress on SNF-at-Home Model, Anticipates Positive 2021 Operating Environment
The potential violations all occurred over a six-month period in 2017 and affected a total of more than 18,000 members, the HHS Office for Civil Rights said. The payer is not admiting liability.
The FDA has started a priority review of Regeneron and Sanofi’s checkpoint inhibitor Libtayo in first-line non-small cell lung cancer (NSCLC), based on data they hope will carve out a niche for the drug in a highly-contested market. PD-1 inhibitor Libtayo (cemiplimab) impressed oncologists earlier… Read More »FDA sets Feb decision date for Libtayo lung cancer challenge to Keytruda
HCA Healthcare employees are asking company investors to meet with workers and demand answers from HCA over PPE and workplace safety concerns.
Facing budget crunches, states will need more time to assess their Medicaid rolls, experts said during a MACPAC hearing.
This issue brief provides an overview of the Medicare Part D prescription drug benefit plan landscape for 2021, with a focus on stand-alone drug plans. It includes national and state-level data on plan availability, premiums, benefit design, cost sharing, information about premium-free plans for low-income… Read More »Medicare Part D: A First Look at Medicare Prescription Drug Plans in 2021
‘Passion point’: Katie Couric, Merck unveil expanded cancer-stories campaign bbulik Thu, 10/29/2020 – 16:13
Takeda has partnered with patient data firm Seqster in a drive to improve care through better access and understanding of patient-level data. The partnership follows Takeda’s investment in the US startup earlier this year. The pharma firm said it wants to leverage the company’s technology… Read More »Takeda to partner on patient-centric data with Seqster
Four FAERS summary statistics reports updated with data through December 31, 2013.
Activ Surgical is building hardware-agnostic surgical software that allows surgical systems to collaborate with surgeons. Founder and Chief Science and Medical Officer Dr. Peter Kim and CEO Todd Usen discussed the company’s goals in an emailed response to questions.
Two people who attended President Trump’s rally at an airport in Gaston County in North Carolina last week have tested positive for COVID-19, the county health department said Thursday.The Gaston County Department of Health and Human Services said…
Molina reported an operating income of $289 million in the third quarter, down from $424 million in the second quarter.
Molina reported an operating income of $289 million in the third quarter, down from $424 million in the second quarter.
Can’t see the audio player? Click here to listen on SoundCloud. White House chief of staff Mark Meadows said this week that “we’re not going to control the pandemic,” effectively conceding that the administration has pivoted from prevention to treatment. But COVID-19 cases are rising rapidly… Read More »KHN’s ‘What the Health?’: As Cases Spike, White House Declares Pandemic Over
As a powerful new wave of infections sweeps the U.S. just ahead of Election Day, the nation’s handling of the nearly 8-month-old crisis has been marked by what health experts see as grave missteps, wasted time and squandered opportunities by leaders at all levels of… Read More »‘So frustrating’: Grave missteps seen in U.S. virus response
The FDA recently unveiled… read more
Sorry, down for maintenance. We apologize for the inconvenience, but we’re performing some maintenance on the subsidy calculators. We hope to have them available shortly. ** Note: This calculator has been updated with premiums for 2020 plans. The Health Insurance Marketplace Calculator provides estimates of health… Read More »Health Insurance Marketplace Calculator
Nota: esta calculadora refleja las primas para 2020. Esta calculadora ilustra las primas (el costo mensual de su seguro) y subsidios para las personas que compran seguro médico por su propia cuenta en el nuevo mercado de seguros de salud (o de intercambio) creado por… Read More »2020 Calculadora del Mercado de Seguros Médicos
The Health Insurance Marketplace Calculator, updated with 2020 premium data, provides estimates of health insurance premiums and subsidies for people purchasing insurance on their own in health insurance exchanges (or “Marketplaces”) created by the Affordable Care Act (ACA). With this calculator, you can enter your… Read More »2020 Health Insurance Marketplace Calculator
Medtronic allegedly paid a South Dakota neurosurgeon kickbacks to use their products and hosted more than 100 events at a restaurant owned by the physician.
We have a new paper in the NEJM from the Eli Lilly effort on monoclonal antibodies against the coronavirus. And there’s no reason not to be up front about it: it’s disappointing. This is the BLAZE-1 trial (mentioned in this recent post), which is studying… Read More »The Latest Antibody Data From Lilly and From Regeneron
Not so long ago (August) Jessica DaMassa and I ran a THCB Bookclub interview with Hemant Teneja & Stephen Klasko about their new book UnHealthcare. And, just because, their friend Glen Tullman sat in….. Fast forward to this week and the three of them plus… Read More »Rehash: The Health Assurance SPAC
Moderna is on track to report initial results from its coronavirus vaccine trial next month, company executives said Thursday.The company is one of the front-runners to produce a vaccine for COVID-19. During an earnings call, Chief Medical Officer…
“Because our family couldn’t afford health insurance, Obama/Biden penalized us about $10,000, then took that $10,000 and used it to pay for others’ free Obamacare. Trump ended that theft.” In a Facebook post, Oct. 20, 2020 A viral Facebook post claims that former President Barack… Read More »A $10,000 Obamacare Penalty? Doubtful.
Source: Christian Heitz from Pexels So long as we could say, “Healthcare is a business,” we could continue to avoid the moral and ethical choices from which such statements shield us. But then COVID-19 came into the picture and the bottom dropped out of healthcare… Read More »COVID-19 Hastens America’s Reckoning with Rural Healthcare
Data consolidation and a modern approach to data management across health care organizations are critical for driving operational efficiency, protecting critical patient data and, most importantly, delivering optimal health outcomes.
Health secretary Matt Hancock has ‘overplayed his hand’ by pushing for total use of remote consultations, according to the chair of the RCGP, who insisted that face-to-face consultations will always be needed to offer ‘best patient care’.
Eli Lilly and Company have entered a $375 million agreement to supply the US government with 300,000 vials of bamlanivimab (LY-CoV555), an investigational neutralising monoclonal antibody for the treatment of mild to moderate COVID-19 in high-risk patients. According to Lilly, under the terms of the… Read More »US to receive 300,000 vials of experimental COVID-19 antibody therapy
Around 9,000 doctors who are due to revalidate between March and July 2021 will have their revalidation dates pushed back by four months as a result of the COVID-19 pandemic, the GMC has said.
This brief examines what the loss of the Affordable Care Act (ACA) would mean for women’s coverage and access to health care.
This page contains the meeting materials for the Peripheral and Central Nervous System Drugs Advisory Committee meetings for 2018, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, and transcript.
This page contains the meeting materials for the Peripheral and Central Nervous Advisory Committee meetings for 2016, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, etc.
Sanofi, despite COVID-19, sees early gains from CEO Hudson’s strategy revamp esagonowsky Thu, 10/29/2020 – 11:26
2017 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee
2020 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee
Today on Health in 2 Point 00, Jess is dismayed at her rising premiums. On Episode 162, Jess and I have more deals to cover. Whoop, which makes a wearable, raises $100 million (including SoftBank money!), bringing their valuation to $1.2 billion. Next, Honor raises… Read More »#Healthin2Point00, Episode 162 | Whoop, Honor, Sidekick Health & more
Sanofi and GlaxoSmithKline (GSK) have signed a statement of intent to make 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine candidate available to the COVAX Facility. The supply is subject to regulatory approval. The statement was signed with Gavi, the global vaccine alliance… Read More »200 million doses of COVID-19 vaccine to be made available for COVAX
Integrated Assessment of Marketing Applications Virtual Workshop
HHS’ Office of the National Coordinator for Health Information Technology has issued an interim final rule to delay compliance deadlines until at least 2021.
UPDATED TIME AND PUBLIC PARTICIPATION INFORMATION: December 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement – 12/15/2020 – 12/15/2020
December 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
An updated EndoScan-V software platform for endotoxin detection and measurement; and the introduction of the Celsis® automated detection solution for rapid sterility to ensure continued product quality and contamination control for pharmaceutical manufacturing clients. READ MORE The post News: Microbial solutions product portfolio updates appeared… Read More »News: Microbial solutions product portfolio updates
Catalent continues big push into cell and gene therapies with Belgian facility buyout kblankenship Thu, 10/29/2020 – 10:57
Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book – 10/27/2020 – 10/28/2020
Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book
In a study using genetically modified mice, researchers found that the nucleus accumbens recruited by cocaine use are largely distinct from nucleus accumbens recruited by sucrose, or table sugar. Because they are separate, this poses the possibility that drug use can be addressed without affecting… Read More »Nucleus accumbens recruited by cocaine, sugar are different
With COVID-19 cases on the rise in Michigan and flu season approaching, healthcare executives said in a news conference that demand for clean laundry has become even more important.
Federal agencies warned that cybercriminals are unleashing a wave of data-scrambling extortion attempts against the U.S. healthcare system designed to lock up hospital information systems, which could hurt patient care just as nationwide cases of COVID-19 are spiking.
A Trump administration official suggested that the theme of a roughly $250 million taxpayer-funded ad campaign to “defeat despair” around coronavirus could be “Helping the President will Help the Country,” according to documents obtained by the…
Among clinicians, there’s a reluctance to raise the issue of cost in any way and run afoul of federal laws. Emergency rooms must at least stabilize everyone, regardless of their ability to pay, under a federal law.
Jefferies analyst David Windley called the results “robust overall but mixed in the details,” calling membership growth underwhelming, and shares fell.
Integration of Movilitas.Cloud and NiceLabel simplifies serialised label printing for highly regulated industries
Movilitas has announced the integration of its Movilitas.Cloud with NiceLabel’s cloud-based label printing solution to simplify serialised label printing for highly regulated industries. With 50 percent of all label printers globally shipped with NiceLabel technology and over 16 million labels printed on cloud-connected printers monthly,… Read More »Integration of Movilitas.Cloud and NiceLabel simplifies serialised label printing for highly regulated industries
Commercial payers are likely already modeling costs. Anthem CEO Gail Boudreaux said Wednesday the insurer considered multiple variables when determining pricing and will follow CMS guidance.
Gilead Sciences said Wednesday that remdesivir, which has been authorized for emergency use since the spring, brought in $873 million in revenues so far this year.
The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune… Read More »PharmaShots’ Key Highlights of Third Quarter 2020
Watch out Merck: FDA grants Regeneron, Sanofi’s Libtayo priority review for coveted first-line use in lung cancer
Watch out Merck: FDA grants Regeneron, Sanofi’s Libtayo priority review for coveted first-line use in lung cancer arlene.weintraub Thu, 10/29/2020 – 09:58
Health insurers will be required to publicly post, in advance, the price for the most common services and procedures, under a rule finalized by the Trump administration on Thursday.The final rule is an effort to inject transparency into the opaque…
A deep learning tool can… read more
The rule forces employer health plans and insurance companies to post in-network and out-of-network rates they negotiate with providers. It also requires insurers to develop online price transparency tools to give patients cost-sharing information.
Takeda, Moderna partner up to bring 50M coronavirus shots to Japan kblankenship Thu, 10/29/2020 – 09:06
After sharing early data from a study of its wearables’ ability to detect Covid-19 early, Fitbit plans to launch a prospective study with Northwell Health to see if its algorithm can detect illness before symptoms appear.
November 2, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement – 11/02/2020 – 11/02/2020
November 2, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Top infectious disease expert Anthony Fauci said Wednesday that it might be 2022 until the U.S. sees “some semblances of normality.”During a University of Melbourne panel discussion, Fauci said it’s possible a “substantial proportion of the people”…
Post issuance of the detailed guidelines, the department received several suggestions and inputs from the pharmaceutical and medical device industry seeking certain amendments in the schemes to enable effective participation of the industry, the statement said.
Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19
Shots: The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other… Read More »Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19
At the start of my video What Does a Low White Blood Cell Count Mean?, you can see what it looks like when you take a drop of blood, smear it between two pieces of glass, and view at it under a microscope: a whole… Read More »What White Blood Cell Count Should We Shoot for?
NHS England primary care medical director Dr Nikki Kanani has thanked GPs and their teams after official data showed general practice delivered 26.65m appointments last month – more than in any month since January this year
NHS England primary care medical director Dr Nikki Kanani has thanked GPs and their teams after official data showed general practice delivered 26.65m appointments last month – more than in any month since January this year
The nation’s top infectious disease expert, Dr. Anthony Fauci, expressed support for a national mask mandate in an interview late Wednesday with CNBC.Fauci explained that the U.S. rate of new coronavirus infections is trending in the wrong…
Already a major player in gene therapy, Novartis has swooped on US startup Vedere Bio in a $280 million deal that builds its position in inherited eye diseases that can lead to blindness. Incubated by Atlas Ventures, Cambridge, Massachusetts Vedere has been flying under the… Read More »Novartis keeps a close eye on gene therapy with Vedere Bio buy
Gilead Sciences is the first and so far only company to claim FDA approval for a COVID-19 treatment with its Veklury antiviral, and its latest financial results reveal the benefit of that achievement. The US drugmaker sold $873 million-worth of Veklury (remdesivir) in the three… Read More »Gilead Q3 revenue rise bolstered by $873m Veklury sales
insitro has landed another big biopharma partnership, signing a five-year collaboration with Bristol Myers Sqibb to develop therapies for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). Neurodegenerative disorders such as ALS and FTD are considered a challenging therapeutic area, with no disease modifying treatments… Read More »BMS joins forces with insitro to develop neurodegenerative treatments
Newly added and withdrawn guidances can be found at Guidances (Drugs). FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA’s current thinking and policy interpretation.
Shots: Vedere Bio received $150M as upfront payments and is eligible to receive up to $130M as milestones making a total deal value of $280M. The transaction closed in Sept’2020 The acquisition will strengthen Novartis’ footprints with the addition of lead preclinical intravitreally injected AAV gene… Read More »Novartis Acquires Vedere Bio for $280M
A greater share of hospitals’ and nursing homes’ political contributions have gone to Democrats in 2020 than in prior election cycles.
Sen. Lindsey Graham has never been a fan of the Affordable Care Act — even though it’s helped dramatically lower the number of uninsured people in his home state of South Carolina. The Republican, who heads the Senate Judiciary Committee, attacked the law at the… Read More »Sen. Graham Complains That 3 Blue States Get a Third of ACA Funding
When Darius Settles died from COVID-19 on the Fourth of July, his family and the city of Nashville, Tennessee, were shocked. Even the mayor noted the passing of a 30-year-old without any underlying conditions — one of the city’s youngest fatalities at that point. Settles… Read More »Hospital Bills for Uninsured COVID Patients Are Covered, but No One Tells Them
RALEIGH, N.C. — Each time Beverly Tucker visited a nursing home or long-term care facility this fall, she brought along a rolling tote bag packed with supplies from the Durham County Board of Elections. Boxes of face masks and face shields. Latex gloves and cleaning… Read More »Despite COVID Concerns, Teams Venture Into Nursing Homes to Get Out the Vote
App-based driving services such as Uber, Lyft, DoorDash and Instacart are bankrolling California’s Proposition 22, which would keep their drivers classified as independent contractors, not employees. Leading into the Nov. 3 election, the ballot measure — which has become the most expensive in state history… Read More »App-Based Companies Pushing Prop. 22 Say Drivers Will Get Health Benefits. Will They?
Does a pharmaceutical company have a moral obligation to acknowledge my participation with an ongoing supply of the product that I helped test?
President Donald Trump entered office seeking a massive overhaul of the Medicaid program, which had just experienced the biggest growth spurt in its 50-year history. His administration supported repealing the Affordable Care Act’s Medicaid expansion, which has added millions of adults to the federal-state health… Read More »The Trump Medicaid Record: Big Goals, Yet Few Successes
The far-right group Super Happy Fun America protests in Boston on October 18. (Mark Peterson / Redux) Kurtis, a young accountant in McKinney, Texas, likes the thing that many people hate about Donald Trump: that the president has left the pandemic response almost entirely up… Read More »Donald Trump, Coronavirus Hero
Chairman of Dr Reddys Laboratories, Satish Reddy said, “We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine… Read More »Dr Reddy’s partners with Department of Biotechnology for Sputnik V vaccine clinical trials in India
Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine
Shots: The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than 3 days prior… Read More »Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine
Advocate M L Sharma petitioner in-person referred to the bench, also comprising Justices A S Bopanna and V Ramasubramanian, the World Health Organization (WHO) report of October 15 and said that nowhere these medicines are designated officially as medicines for coronavirus.
Collaboration includes two therapeutic candidates – MP0420 and MP0423
French pharma will test investigational candidate alongside MSD’s Keytruda
New guidance based on research from University of Manchester
Agreement will also see companies develop treatments for frontotemporal dementia
The company said the newly approved medication will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting
Shots: The P-ll/lll trial involves assessing of REGN-COV2 (8gm/2.4gm) + SOC vs PBO + SOC in 524 patients with mild-to-moderate COVID-19 in an outpatient setting The study met its 1EPs & 2EPs demonstrating a reduction in viral load and patient medical visits. Moreover, Regeneron is… Read More »Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting
Episode 30 of “The THCB Gang” was live-streamed on Thursday, October 28th! Tune in below! Matthew Holt (@boltyboy) will be joined by some of our regulars and this episode will be a COSTUME PARTY! Come join some of our gang and see the crazy costumes… Read More »THCB “SPOOKY” Gang: Episode 30 10/29 LIVE 1PM/4PM ET
Florida fails to attract bidders for Canada drug importation program Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Gov. Ron DeSantis of Florida wants the state to buy less expensive prescription drugs from Canada under a plan he designed and President Trump endorsed. However,… Read More »Florida fails to attract bidders for Canada drug importation program
Vaccine makers can skip U.S. inspections Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 FDA typically conducts inspections of drug manufacturing plants before granting approval for a pharmaceutical company’s new drug. However, inspections will not be necessary for COVID-19 vaccine developers that gain emergency… Read More »Vaccine makers can skip U.S. inspections
Bipartisan lawmakers call for overhauling medical supply chains Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 At The Hill‘s “America’s Agenda: COVID-19 & A Responsive Rx Supply Chain” event on Tuesday, lawmakers from both parties said the nation needs to examine and restructure its… Read More »Bipartisan lawmakers call for overhauling medical supply chains
Rampant shoplifting leads to another Walgreens closing in S.F. Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Following months of widespread thefts by brazen shoplifters, the Walgreens at Van Ness and Eddy in San Francisco is getting ready to close, according to Walgreens spokesman… Read More »Rampant shoplifting leads to another Walgreens closing in S.F.
Gateway Health and Giant Eagle Pharmacy pilot an innovative approach to addressing the opioid epidemic in Allegheny County
Gateway Health and Giant Eagle Pharmacy pilot an innovative approach to addressing the opioid epidemic in Allegheny County Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Pittsburgh-based Gateway Health Plan has partnered with Giant Eagle Pharmacy to introduce Medicaid members to Project Lifeline, a… Read More »Gateway Health and Giant Eagle Pharmacy pilot an innovative approach to addressing the opioid epidemic in Allegheny County
Despite the Trump administration’s new policy, many pharmacies still won’t vaccinate children against influenza
Despite the Trump administration’s new policy, many pharmacies still won’t vaccinate children against influenza Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Although the Trump administration has empowered U.S. pharmacists to administer influenza vaccine to children in hopes of reducing the effect of concurrent… Read More »Despite the Trump administration’s new policy, many pharmacies still won’t vaccinate children against influenza
Hospitals are reeling under a 46% spike in COVID-19 patients Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 The number of Americans falling ill with COVID-19 is escalating, and hospitals are staggering under the burden. The hospitalization rate is up approximately 46% nationwide from… Read More »Hospitals are reeling under a 46% spike in COVID-19 patients
Oxford, AstraZeneca vaccine shows promising immune response in older adults Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 An interim analysis suggests that a COVID-19 vaccine being developed by AstraZeneca and the University of Oxford produces a favorable immune response and low levels of… Read More »Oxford, AstraZeneca vaccine shows promising immune response in older adults
Association of therapies with reduced pain and improved quality of life in patients with fibromyalgia
Association of therapies with reduced pain and improved quality of life in patients with fibromyalgia Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Researchers in Brazil and Australia scrutinized therapies for alleviating pain and enhancing quality of life (QOL) in people with fibromyalgia, most… Read More »Association of therapies with reduced pain and improved quality of life in patients with fibromyalgia
Preventing the spread of SARS-CoV-2 with masks and other ‘low-tech’ interventions Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Use of face masks is essential for combating coronavirus infection, which is primarily transmitted through respiratory droplets, explains National Institute of Allergy and Infectious Diseases… Read More »Preventing the spread of SARS-CoV-2 with masks and other ‘low-tech’ interventions
Severe COVID-19 cases leave lasting effects, including on mental state Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Physicians are now starting to understand the long-term effects of COVID-19, including fatigue, chest pain, and heart inflammation. Many of these effects do not have any… Read More »Severe COVID-19 cases leave lasting effects, including on mental state
FDA approves lotion for nonprescription use to treat head lice Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 FDA approved on Tuesday a lotion to treat head lice for nonprescription use through a process known as a prescription-to-OTC switch. FDA originally approved ivermectin (Sklice—Arbor… Read More »FDA approves lotion for nonprescription use to treat head lice
Teladoc Health posted $288.8 million in revenue for 2020’s third quarter as it prepares for a pending $18.5 billion merger with Livongo.
CMS’ interim rule states that Medicare will cover Covid-19 vaccines approved by the FDA, including those receiving emergency use authorization, in a reversal from its usual policy. The vaccine will be made available at no cost to Medicare beneficiaries.
Medicare will cover any potential coronavirus vaccine for free, under a new Trump administration policy officially announced Wednesday.The new rule from the Centers for Medicare and Medicaid Services means any vaccine that receives Food and Drug…
Overnight Health Care: White House seeks to clarify press release claiming pandemic over | Fauci: COVID vaccine likely not available until next year
Welcome to Wednesday’s Overnight Health Care.The White House wants to clarify that President Trump does not really think the pandemic is over and is instead making ending it his top priority. There’s more evidence masks work. And Anthony Fauci doesn…
MedCity Pivot Podcast: A conversation with Mark Bertolini about healthcare policy, Covid-19 and 5G in healthcare
Expanding Medicaid and then adjusting Medicare coverage based on financial and income status would be one way to improve healthcare policy and make sure that more Americans have healthcare when they need it.
Coronavirus (COVID-19) Update