Macleods Pharmaceuticals Ltd-Recruitment for PPIC Executive -Apply Now

Macleods Pharmaceuticals Ltd-Recruitment for PPIC Executive -Apply Now

Job Description

Material planning : Calculation of material (RM & PM) and arranging it on time by coordination with purchase in a way to avoid shortage or excess inventory. Updation of Order in Order book and timely closure of orders. Prepare 6 months plan for material planning. Production and Day wise schedule. Knowledge of Manufacturing areas for Day wise scheduling activities. Should be well conversant with M.S. Excel Should have basic knowledge of Regulatory filings and Quality Assurance concept and documents Types. To coordinate with RM/PM/API and Engineering items purchase teams. Coordination with Packing development team for timely release and approval of Artwork and issuance od base documents for batch record preparation. Overall Knowledge of Material planning, Capacity and production planning and Supply Planning.

Post Name: PPIC Executive

Qualification: B.Pharma+ MBA

Experience: 05-10 years

Location: Mumbai

Openings: NA

Kindly share your updated CV : [email protected]

Thanks & Regards
Mayuri Muneshwar

Click Here For Job Details & Apply Online

Macleods Pharmaceuticals Ltd-Recruitment for PPIC Executive -Apply Now

Practical hints to set up value and build trust through pharma content and digital assets in 2021

In 2020, the world was under the havoc caused by the COVID19 pandemic, and its shadows are still among us. But despite that, the pharmaceutical industry put some light at the end of this pandemic tunnel.

In 2021, numerous hurdles will remain, but there are two sides of the same medal. These obstacles are also helping provoke innovative ideas and becoming the starting point of growth to navigate through turbulent times. The whole healthcare industry is rethinking its relationships with various types of customers. Marketing and sales teams are adapting their approaches to the new reality and upgrading their marketing strategies at scale.

With a couple of weeks in 2021 passing by, we have come to a conclusion. This year (and further) Pharma will be put into the limelight even long after the pandemic starts fading. Though its contribution should go far beyond just the mainstream – the expectations and requests from HCPs and patients are rising proportionally.

Amazing trends that will bear more fruit than ever

Search for online content is a common thing especially for healthcare experts. After the tremendous shift to digital caused by pandemic, physicians are getting more involved in looking for therapeutical information themselves. They are also self-educating through digital means (multiple platforms, online courses, communities, and many more). Lots of HCPs are now using medical apps and websites to find the content they trust for their purposes. Valuable health-related information is becoming a prerequisite. Furthermore, this content is not just presented in lines or eDetailing – there are some predominant features already included, such as interactive videos, personalized videos, dynamic emails, and other types of pharma content. This leads to improved and more valuable patient experience with pharmaceutical brands.

“According to a recent study, after viewing a video on a certain healthcare topic, 39% of patients made an appointment with the physician”.

Technological advancement in the medical and pharmaceutical fields will be continuously changing the industry, while the demand for accurate data will only rise as well. Pharma and life science companies have to stay alert to the rising amount of inaccurate information concerning health and therapy approaches. We are living in the era where Instagram bloggers can become the source of trust. In the same way, a single post can affect the minds of millions of people. Well, who knows, maybe, the internet-savvy physicians will be soon prescribing health apps, along with drugs…

Advanced analytics, AI, and machine learning will only enlarge remote patient monitoring. The use of analytics-driven patient monitoring can help maintain HCPs alerting to any issues (that need to be fixed) related to patients’ health. Increased transparency in everything related to the supply chain in life sciences will be coordinated by the new paradigm “Industry 4.0” (known as “Industrial Internet of Things, the German smart manufacturing concept). With the new principles, the value will be created through the interconnection of devices, machines, and other industrial equipment.

“But there should not be concerns between traditional medicines and digital technologies. In 2021, we will see an increasing number of drugs developed in connection with digital therapeutics solutions”.

 Kuldeep Singh Rajput, CEO of Biofourmis

With so many uncertainties around

HCPs and patients are now expecting beyond-the-pill support and much more transparent communication. Creating great content is not enough. The recent survey revealed that only 44% of patients report their needs are being met. The biggest gaps were seen in engaging directly with patients and HCPs.

Patient centricity should be no more about an impressive goal – it’s a must. Some healthcare professionals declared they were more willing to engage and work with pharma brands, which they observed as more patient-centric. Besides, more than 50% of physicians reported they prescribed medicine from a pharma company they considered more patient-oriented.

Beyond personal: delivering the coherent experience

With the omnichannel approach joined the game, HCPs’ channel preference has shown a significant shift. Now pharma is challenged to maintain effective collaboration without face-to-face cooperation and, of course, remote detailing has been rising to peak levels. Among the most wide-spread pharma-HCP communication channels still prevail eDetailing, video conferences with medical representatives, and emails. Let’s examine in what way interactive presentations can help pharma to represent its product in a much more informational way:

  • to provide the rapid and necessary information in time
  • to include a brand portfolio that will help HCPs to become familiar with the scope of the company’s products
  • to leave the space for learning. Interactivity allows HCPs to learn about new treatments, innovative approaches in diagnostics, etc.

How about emailing? What makes this channel engaging for the physician? Ironically, its biggest advantage is eDetailing’s most obvious shortcoming: timing. Just think, the emails could be opened at any time, from any device. For example, the physician can open it on a mobile or desktop, read the subject line first and then investigate the content inside (using a link, an invitation, etc.). Besides, they can re-read the emails a dozen times.

Another crucial means for running remote consultations is video conferencing. There are a lot of quality platforms and apps for virtual meetings with interactive services included (chats, screen sharing, and many more). This practice is even more beneficial in terms of the time aspect. Patients can make online appointments with their doctors and be treated faster. Physicians might give clear instructions, examine or diagnose patients without leaving their homes. During the lockdown period, this tool assists as a helpful alternative for patients and HCPs regardless of their physical location.

Go a step further

In the world of pharma, gamification has started to play a role far beyond just entertainment. For example, look at how Nike+ app works. It tracks the length of your run and sends you virtual awards after you stop. The ones who show the most excellent results are placed on a leader dashboard. Isn’t that fun?

Here is one more case. This game has proven exceptionally successful in reinforcing HCPs’ practice. Over 15,000 healthcare workers have already used “Paper to Patient”. Physicians can complete training materials there and put that knowledge into practical tasks (yet on virtual patients). The last ones represent various levels of health. Depending on how thoroughly the doctor can diagnose and treat those patients, he or she receives the award and points for every virtual consultation.

“Dynamic” connectivity

Since wearable technologies created a new voice and tone among patients, HCPs, and pharma, the demand for mobile health applications is only rising. Just take a look at some most prevalent mobile apps types for HCPs: disease management and diagnostics, calculators, medical education, apps for medical communities, patient education, and so much more. Every particular app is targeted to solve a specific request. To name just a few, reaching a higher level of personalization, straightening patients’ awareness and adherence, providing better guidance to field and sales forces. A large-scale number of mHealth apps development is covered by Viseven expertise no matter whom they are intended for (physicians, patients, or pharma representatives).

Of course, trends will come and go, but customer-centricity is the one that will always be in fashion. The future of powerful and just-in-time customer experience is closely tied with the full definition of their many needs and putting the customer at the center of whatever the industry does. The next step is to implement that knowledge into the relevant engagement strategies.

From this perspective, the key to growth for any pharmaceutical brand is to thoroughly engage and pull HCPs’ interest through worthwhile and valuable content. Our omnichannel professionals with years of experience know exactly how to produce content that is digestible for your audience. It is all about creating content that is channelless and universal: from eDetailing creation, dynamic emails, self-detailing tools, mobile apps to website development.

No more one-way communication. Turn to our Viseven experts for insights and guidance on how to create beyond-the-pill content marketing campaigns and get full support on executing a leading omnichannel strategy.

The post Practical hints to set up value and build trust through pharma content and digital assets in 2021 appeared first on Viseven.

Biden unveils national strategy that Trump resisted

Biden unveils national strategy that Trump resisted

cbaker_admin
Sat, 01/23/2021 – 08:00

Unlike his predecessor, President Biden is embracing a more centralized strategy for managing the COVID-19 pandemic. He signed a flurry of executive orders and presidential directives on January 21, including one that institutes new mask mandates for interstate travel, one that creates a national board to expand access to testing, and another that requires international visitors to quarantine upon arrival in the United States. Biden pitched his National Strategy for the COVID-19 Response and Pandemic Preparedness as a “wartime effort” and did not soft-pedal the grim details. The number of U.S. deaths linked to COVID-19, he projected, could surpass 500,000 next month. To rein in the public health crisis, the president is also calling for use of the Defense Production Act as needed to increase vaccine supply, the release of workplace safety guidelines, new guidance on reopening schools and businesses, and federal reimbursement to states that leverage the National Guard to expedite vaccinations. Analysts say the Biden roadmap is overly optimistic in some ways and short-sighted on other points. What is more certain is that the White House’s handling of the crisis will shape the public’s view of the administration. “History is going to measure whether we are up to the task,” Biden acknowledged.

‘Pixie Dust’: Why some vaccine sits on shelves while shortages intensify nationwide

‘Pixie Dust’: Why some vaccine sits on shelves while shortages intensify nationwide

cbaker_admin
Sat, 01/23/2021 – 08:00

While kinks in the national COVID-19 vaccination rollout have been blamed largely on limited supply, some doses are sitting unused in some states. Mixed signals over the amount of vaccine available from week to week, questions over how much is needed to immunize priority groups, confusion over vaccine eligibility, and some public reluctance to the vaccine have slowed ordering and distribution. At the same time, many providers lack the cold-storage capacity required for the Pfizer vaccine, and some states are setting aside product for long-term care facilities. As a result, while many locations are ordering less vaccine than what has been earmarked for them, others have depleted their stores and are desperate for additional doses. “We don’t have the visibility that we would hope to have into supply and allocations,” admits Jeff Zients, who is spearheading the Biden administration’s pandemic response. The confusion could deepen next week, when state allocations will be adjusted to account for a change from five vaccine doses per Pfizer vial to six.

Lilly antibody drug prevents COVID-19 in nursing homes, study finds

Lilly antibody drug prevents COVID-19 in nursing homes, study finds

cbaker_admin
Sat, 01/23/2021 – 08:00

Eli Lilly & Co. reported Thursday that bamlanivimab, an antibody-based drug, prevented COVID-19 infection among many nursing home and assisted-living residents and staff members. According to Lilly, the drug lowered the risk of both staff and residents becoming sick with COVID-19 by about 57%, compared with a placebo 8 weeks after receiving doses. Among residents, the company noted, the effect was more significant, with an 80% reduction in COVID-19 risk. The partial results were from a Phase III study conducted in tandem with NIH. Lilly announced the findings in a news release and said it plans to publish the full results in a peer-reviewed medical journal. The company said it plans to ask FDA to expand the authorized use for bamlanivimab to include protecting people in long-term care facilities where someone has recently been diagnosed with COVID-19.

FDA approves first ER injectable drug regimen for adults living with HIV

FDA approves first ER injectable drug regimen for adults living with HIV

cbaker_admin
Sat, 01/23/2021 – 08:00

FDA approved on Thursday cabotegravir and rilpivirine, injectable formulation (Cabenuva—ViiV Healthcare) as a complete regimen for the treatment of HIV-1 infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. This is the first FDA-approved injectable, complete regimen for adults with HIV that is administered once a month. The agency also approved cabotegravir, tablet formulation (Vocabria—ViiV Healthcare), to be taken in combination with oral rilpivirine (Edurant) for 1 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,” said John Farley, MD, MPH, director of the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research. “This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen.” The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials involving more than 1,100 adults with HIV who were virologically suppressed prior to initiation of treatment with Cabenuva. The most frequently reported adverse reactions to the treatment were injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. Both Cabenuva and Vocabria received FDA Fast Track and Priority Review.

California says Moderna vaccine safe after briefly halting immunizations

California says Moderna vaccine safe after briefly halting immunizations

cbaker_admin
Sat, 01/23/2021 – 08:00

California has determined that a batch of the Moderna vaccine is safe after temporarily suspending immunizations from a shipment of more than 300,000 doses after fewer than 10 people required medical attention. California State Epidemiologist Erica Pan, MD, MPH, authorized health providers to “immediately resume” vaccine administration after the California Department of Public Health “found no scientific basis to continue the pause.” Specifically, the state had halted the administration of doses from the “41L20A” batch because of “possible allergic reactions.” Pan on Sunday recommended halting the distribution due to “a higher-than-usual number of possible allergic reactions” at a community vaccination clinic in San Diego. Moderna said it was examining the batch following reports of medical issues. Approximately 330,000 doses had been delivered to nearly 300 providers in California between January 5 and 12. Most of those providers stopped administering those doses as the state, Moderna, FDA, and CDC launched a probe.

Efficacy and safety of antidepressants for the treatment of back pain and osteoarthritis

Efficacy and safety of antidepressants for the treatment of back pain and osteoarthritis

cbaker_admin
Sat, 01/23/2021 – 08:00

Antidepressants are widely used to treat pain, despite a lack of conclusive evidence to support this practice. To better understand the risks and benefits of antidepressants in the setting of back and osteoarthritis pain, researchers in Australia conducted a systematic review and meta-analysis. Evidence was derived from 33 randomized controlled trials including 5,318 participants with low back or neck pain, sciatica, or osteoarthritis of the knee or hip. The studies compared pain intensity and disability with antidepressants vs. placebo. The review authors found moderate-certainty evidence that serotonin-noradrenaline reuptake inhibitors (SNRIs) reduce these outcomes for up to 3 months. Although the effect fell shy of clinical significance among patients with back pain, a clinically important benefit could not be ruled out in the case of osteoarthritis. SNRIs, along with tricyclic antidepressants (TCAs), additionally may offer clinical benefit to people with sciatica; but the certainty of that evidence was low to very low, and SNRIs also significantly elevated the risk of adverse events. Meanwhile, TCAs and other antidepressants demonstrated little effect on pain or disability. “Large, definitive randomized trials that are free of industry ties are urgently needed to resolve uncertainties about the efficacy of antidepressants for sciatica and osteoarthritis highlighted by this review,” the authors concluded.

CVS Health, Walgreens pharmacies to roll out COVID-19 vaccines in Massachusetts

CVS Health, Walgreens pharmacies to roll out COVID-19 vaccines in Massachusetts

cbaker_admin
Sat, 01/23/2021 – 08:00

In Massachusetts, the Baker-Polito administration announced that at least 15 CVS Health and Walgreens locations will receive a total of 10,000 COVID-19 vaccines to administer this week. These locations will be in areas across the state with less access to convenient vaccination facilities. Eligible residents in Phase 1-eligible priority groups can now view sites and book an appointment. Some 40 vaccination sites will be added the week of January 25 through current partners and collaboration with additional partners, including Wegmans, Big Y, Price Chopper, Stop & Shop, and Hannaford. The Baker-Polito administration is also launching the Hospital Depot Initiative for independent physician practices prioritized under Phase 1. The Massachusetts COVID-19 Command Center and Department of Public Health, in collaboration with the Massachusetts Medical Society and Mass General Brigham, is managing this initiative starting with COVID-facing health care workers. For clinical practices that lack staff or storage capacity to handle larger, direct allocations of vaccine doses, a depot hospital will receive the doses on their behalf and redistribute vaccine and all ancillary materials for office-based vaccination. In some cases, the hospital will provide direct vaccination to health care workers. The Massachusetts Medical Society is overseeing communications and coordination with physician practices.

Amazon offers to help Biden administration with COVID vaccine distribution

Amazon offers to help Biden administration with COVID vaccine distribution

cbaker_admin
Sat, 01/23/2021 – 08:00

Online retail giant Amazon has reached out to President Joe Biden, telling him that it is willing and able to help achieve his goal of vaccinating 100 million Americans during the first 100 days of his administration. “Our scale allows us to make a meaningful impact immediately in the fight against COVID-19, and we stand ready to assist you in this effort,” Amazon Worldwide Consumer CEO Dave Clark wrote in a January 20 letter to the new commander-in-chief. He also called for Amazon staff, many of whom are designated as essential workers, to be immunized as soon as possible.

Minnesota pharmacies ask to be included in COVID-19 vaccine rollout

Minnesota pharmacies ask to be included in COVID-19 vaccine rollout

cbaker_admin
Sat, 01/23/2021 – 08:00

Addressing a Minnesota Senate health committee recently, Minnesota Pharmacists Association Executive Director Sarah Derr said nearly 560 pharmacies in the state have registered to be vaccine providers. She said, “Pharmacies are currently a little frustrated as they have not heard of any plans … in contrast to pharmacies in other parts of the country.” North Mankato is one of nine sites in the state that will start administering vaccines to about 12,000 people, including some educators and child-care workers, starting January 21. As of January 20, 200,840 Minnesotans have been vaccinated against COVID-19. A state tracking website shows that approximately 40% of the nearly 597,000 doses delivered to health care providers and long-term care facilities have been used. Officials hope to eventually increase the number of community vaccination sites as the federal government allocates more doses to the state.

Dierbergs to sell its pharmacy operations to Mercy

Dierbergs to sell its pharmacy operations to Mercy

cbaker_admin
Sat, 01/23/2021 – 08:00

Dierbergs Markets has agreed to sell all 22 of its traditional and specialty pharmacies to Mercy, a St. Louis-based health system, for an undisclosed price. Mercy will operate the Dierbergs pharmacies in their current locations under a long-term lease, officials said Tuesday. Mercy may also develop pharmacies at future Dierbergs locations. Pharmacists, pharmacy technicians, and other pharmacy associates currently employed by Dierbergs who are in good standing when the transaction closes will become Mercy employees at their current locations, subject to completing hiring requirements, officials said. The deal brings Mercy’s total number of pharmacies to 34 in the St. Louis area and 48 system-wide.

New NABP report explores how pharmacists can safeguard patients from risky dietary supplements

New NABP report explores how pharmacists can safeguard patients from risky dietary supplements

cbaker_admin
Sat, 01/23/2021 – 08:00

In its latest Rogue Rx Activity Report, the National Association of Boards of Pharmacy (NABP) examines risks associated with adulterated OTC dietary supplements. NABP says dietary supplements can be contaminated with undeclared active pharmaceutical ingredients; contain adulterants such as amphetamine derivatives, steroids, or untested new drugs; and/or falsely market claims to treat diseases. The report asserts that pharmacists can provide consumers with information regarding the risks associated with these supplements. NABP supports boosting education for pharmacists about misbranded and adulterated dietary supplements in addition to counseling for patients regarding safety concerns. The U.S. dietary supplement market is a $40 billion industry with at least 50,000 products available for sale. Consumers often erroneously believe FDA verifies the safety of supplements prior to sale. However, supplements fall under the subcategory of food, so FDA regulates these products only after they enter the marketplace. The report cites a study estimating that 23,000 emergency department visits and 2,000 hospitalizations per year occur nationwide because of adverse events related to misbranded dietary supplements. FDA maintains an online tainted dietary supplements database for consumers’ reference, handles recalls, and issues alerts and warning letters. In some cases, FDA works with the Department of Justice and other federal agencies to pursue criminal penalties. FDA can also place a regulatory ban on an ingredient.

McLaren Health and feds reach record $7.75 million settlement of drug allegations

McLaren Health and feds reach record $7.75 million settlement of drug allegations

cbaker_admin
Sat, 01/23/2021 – 08:00

Michigan-based health system McLaren Health Care Corp. will pay $7.75 million to settle a federal investigation into officials distributing opioids and other drugs without prescriptions. This is the largest fine in U.S. history involving allegations of drug diversion. The penalty settles a years-long DEA investigation into whether McLaren officials violated federal drug laws by illegally distributing powerful analgesics central to the nation’s opioid crisis. McLaren officials have entered a 3-year agreement to address the health system’s drug-handling responsibilities, perform mandated audits of controlled substances, and provide training on preventing drug diversion. McLaren fired one pharmacist accused of diverting opioids for his own use and launched a review of pharmacy protocols going back more than a decade, which uncovered bookkeeping irregularities. The review also discovered drugs were being distributed at community pharmacies under old protocols enacted before McLaren acquired those locations. McLaren noted in a statement on Tuesday that it exited its community pharmacy business in 2018, an unrelated move that involved pharmacies linked to the DEA investigation. Other aspects of the settlement include continuing and implementing several plans, including an oversight committee that developed a system-wide drug diversion policy, mandatory training for approximately 10,000 employees, and retaining an outside pharmacy management company to oversee inpatient pharmacies.

Gland Pharma Ltd-Openings (30 Openings) for QC Department-Apply Now

Gland Pharma Ltd-Openings (30 Openings) for QC Department-Apply Now

Job Description

♦We have an Urgent Requirement for Quality Control Department, Interested Candidates, please share your Updated profile to [email protected]

Exposure On Wet analysis, Stability, Finished goods. Experience on HPLC, UV, IR & GC is must. Maintain Good Laboratory Practices. Maintain Good Documentation Practices.

Post Name: QC

Qualification: Any Graduate

Experience: 0-05 years

Location: Hyderabad

Openings: 30

Note: Only male candidates required to work in Shifts. Candidates Serving notice period or immediate joining’s are preferable

Regards,
Archana Reddy N
Team HR
Gland Pharma Limited, Dundigal Hyderabad

Click Here For Job Details & Apply Online

Gland Pharma Ltd-Openings (30 Openings) for QC Department-Apply Now

Pfizer Will Ship Fewer Covid-19 Vaccine Vials to Account for ‘Extra’ Doses

After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose.

Birx says she regularly considered quitting

Deborah Birx, the former coordinator of the White House coronavirus task force under President Trump, said in an interview excerpt released Friday that she regularly considered quitting her post during the previous administration.Birx told CBS…

Overnight Health Care — Fauci: Lack of facts ‘likely’ cost lives in coronavirus fight | CDC changes COVID-19 vaccine guidance to allow rare mixing of Pfizer, Moderna shots | Senate chaos threatens to slow Biden’s agenda

Welcome to Friday’s Overnight Health Care.Anthony Fauci said lives could have been saved if the Trump administration was more honest. The CDC has quietly changed its guidance on vaccines and President Biden’s COVID-19 agenda is being stalled in the…

Pfizer Will Ship Fewer Vaccine Vials to Account for ‘Extra’ Doses

After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose.

Fauci infuriated by threats to family

The nation’s top infectious diseases expert Anthony Fauci will be on CBS Sunday Morning to talk about working with President Biden and the threats his family has received due to his work. Fauci said the threats his family has received due to…

VirtualHealth, Prealize establish care management collaboration

Prealize Health, an artificial intelligence (AI)-enabled predictive analytics company, announced a new partnership with VirtualHealth, provider of HELIOS, a software-as-a-service (SaaS) care management platform. The two companies will incorporate Prealize’s healthcare insights into VirtualHealth’s HELIOS program.

HELIOS, according to VirtualHealth, connects the end-to-end healthcare ecosystem, gathering medical, behavioral, social and service data to deliver a 360° view of each member. The platform’s proprietary clinical decision rule engines and automated workflows aim to guide clinicians and care managers toward proper communication, assessment, care planning and educational activities for every person in their care.

Prealize’s AI-enabled predictive analytics help payers and providers proactively address individuals’ health. The company says that its predictions have shown to be twice as accurate as that of other leading companies, enabling payers and providers to act as early as 12 months before a diagnosis hits a claim.

The post VirtualHealth, Prealize establish care management collaboration appeared first on Pharmaceutical Commerce.

Augmedix Launches National Roll-Out of Tech-Enabled Virtual Scribes to Assist Busy ED Clinicians

Augmedix Launches National Roll-Out of Tech-Enabled Virtual Scribes to Assist Busy ED Clinicians

What You Should Know:

Augmedix, a provider of
remote medical documentation and live clinical support launches the national
rollout of a transformative tech-enabled medical documentation service powered
by virtual scribes and created specifically for busy Emergency Department (ED)
environments.

– Augmedix trains remotely-located scribes in emergency
medicine documentation to alleviate the administrative burden for clinicians,
which is especially important today as these clinicians are on the front lines
of the COVID crisis.

– The virtual scribes use the proprietary Augmedix
Notebuilder automation technology to ensure consistent, accurate documentation,
which adds value and potential return on investment relating to ancillary
billing opportunities unique to the ED.

– The Augmedix ED scribes support key facets of
documentation, real-time alerts, and Electronic Health Records tasks. This
includes tracking and providing reminders for labs, radiology, and EKGs, as
well as attaching patient education materials at the end of each encounter.

– Additionally, Augmedix scribes positively impact clinician
workflow and the patient experience by removing barriers between the ED and
hospitalists. The ED virtual scribes assist clinicians to optimize workflow by
prioritizing documentation requirements for patients being admitted, while
still ensuring all ED patient documentation is complete for clinician review
and sign-off by the end of their shift.


Northway Biotech unveils new 30,000 square-foot biopharm manufacturing facility

Northway Biotech (formerly Northway Biotechpharma), a biopharma contract development and manufacturing organization (CDMO), has opened its new 30,000-square-foot process development and current good manufacturing practices (cGMP) site in the Greater Boston area (Waltham, MA).

From cell line development to cGMP DS manufacturing and aseptic filling, the facility is expected to provide end-to-end services for biologics microbial and mammalian-based biologics.

Currently, the new site has fully established process, analytical method development and quality control labs supporting local and international customer projects since summer 2020. The cGMP biomanufacturing suite will contain 500 L microbial and 2,000 L mammalian bioreactors which will be operational in the fourth quarter, representing a capital investment program worth $40 million.

The post Northway Biotech unveils new 30,000 square-foot biopharm manufacturing facility appeared first on Pharmaceutical Commerce.

The Other Guys

Writing the other day about the lipid formulations used in the current mRNA vaccines makes me want to highlight something else that I hit on from time to time around here. When you learn in school about the major classes of biomolecules, you hear about proteins, lipids, carbohydrates, and nucleic acids. That’s a reasonable classification, but you hear a lot more about the first and last items on that list than you ever hear about the middle two.

That’s understandable, because after all, nucleic acids (as DNA) code (through the intermediacy of RNA) for proteins. And it’s those proteins that are involved in either synthesizing the lipids or carbohydrates (through a long list of enzymatic pathways) or bringing them in from our diets, as transporter proteins and the like. So proteins really do take the lead, but those other two categories are still their own worlds. Lipids, of course, make up the cellular membranes that surround (that have to surround) bacteria, archaea, and every single cell with a nucleus. And they’re used on a large scale for things like myelin sheaths around nerve tissue, and on a molecular scale as energy feedstocks (two carbons at a time, being peeled off all those fatty acids) and starting materials for the synthesis of a long list of hormones and cytokines. The carbohydrates are of course also at the center of that cellular metabolism energy landscape, with glucose in the Krebs cycle cranking out the common currency of ATP (itself a carbohydrate derivative). But they also decorate the surfaces of nearly every protein in the body, and are intimately involved in regulating their localization and function. The surfaces of entire cells are no different – the immune system’s recognition of self depends on complex carbohydrates. And I haven’t even mention how ribose and 2-deoxyribose are crucial to the structures of all those nucleic acids.

No, neither of these compounds classes are exactly junior partners. But they don’t get the attention that the others do, and that goes for the laboratories as well as the popular imagination. The biggest problem is that both lipids and carbohydrates are just intrinsically harder to work with than are proteins and nucleic acids. Both of those biopolymers are hooked up (for the most part) in repetitive ways from a rather small list of common building blocks. That’s given us the chance both to work out ways to read off those sequences and to build machines that will synthesize them for us. Those either co-opt the exquisite cellular machinery (which we’ve adapted to work in vitro) or use automated organic chemistry reactions that we’ve come up with ourselves. The list of Nobels and other awards for all the discoveries in those fields is a very long one indeed, as it should be.

But look at carbohydrates. Those also form long polymeric structures, and the list of building blocks is no shorter than it is for the proteins. But the ways in which they can be linked – now, that’s a headache. Good ol’ glucose has five OH groups (counting the anomeric center at the first carbon) that can be involved in such linkages. In addition, that anomeric center can be “up” or “down” (alpha and beta glycosides), and glucose can tie itself into either a six-membered ring or a five-membered one, depending on conditions.

Now run through the list of all the six-carbon and five-carbon sugars (and the smaller carbohydrates too, can’t forget those), the various oxidation state changes like the sugar alcohols and acids, the keto sugars, and the important variants where one or more of those OH groups they’re all decorated with is missing or replaced with an amine and. . .well, you’re looking at a lot of compounds that can be fitted together into an insanely large number of different compounds. The number of possible proteins that can be assembled out of twenty amino acids gets out of hand pretty quickly, but it’s nothing compared to how fast the number of possible complex carbohydrates will take off on you.

And as you’d figure, the chemistry needed to make those things is all over the place, too. With proteins, it’s just amide bond, amide bond, amide bond in an endless series. Don’t get me wrong, that’s bad enough, what with the reactive side chains and the chances of messing up the single chiral center if you use synthetic conditions that are too severe. But even just putting a single substituent at C1 of a given sugar, glycoside formation. . .well, there are entire books full of conditions for the Koenigs-Knorr reaction and Fischer glycosidation, and those are the two simplest and most direct techniques we have. There’s been a lot of work (and a lot of progress) over the years, but there is still no general set-it-and-forget-it carbohydrate synthesis machine, the way that there is for proteins and for nucleic acids. The number of different chemistries (and the number of ways in which they can go wrong) is still too big a problem. That goes for sequencing them back down, too: if you isolate some new complex carbohydrate and want to figure out its composition, you do not pop it into some sort of sequencer and go to lunch. No, you settle down for weeks, months (possibly years) of work. The problem is exacerbated by the huge molecular weight of some of the biological polysaccharides. And as for three-dimensional structures, from what I can see the field is just barely lifting itself up off the ground compared to what we know about protein and oligonucleotide tertiary structure.

Lipids suffer from many of the same problems. They don’t have as much of the multiple-sites-of-attachment thing going, until you consider that large important classes of them are hooked up to (you guessed it) the OH groups of various carbohydrates. So that plunges you right back into the structure determination problems and the synthetic problems we were just talking about. But another tricky part of lipids is that they can be just beastly to handle and characterize via the usual tools. We have a lot of chromatographic tricks to separate out polar compounds (and that includes the proteins and the carbohydrates). But making fine distinctions between different varieties of, well, grease is something else again. The physical interactions are just not as well-defined as you have with (say) hydrogen bonds and charged groups, so you end up chromatographically with broader peaks and worse resolution. Techniques like NMR suffer as well: the long carbon chains of many lipid molecules can be hard to distinguish and assign. Steroid backbones, now those are well worked out and you can find your way around them. But a 22-carbon chain with a double bond somewhere in the middle of it looks an awful lot like a 24-carbon chain with that double bond moved a couple of spaces down, and that goes for NMR, for HPLC, and many other techniques.

It doesn’t necessarily look so similar to your body, though. Think about the state of human nutritional advice, with all the conflicting evidence about the desirability of various saturated, unsaturated, monounsaturated, and polyunsaturated fats. Biochemically, our cells make a lot of fine distinctions between structures that we ourselves have to stare at closely to see any differences at all. The mention of nutrition is to emphasize that we don’t understand a lot of these biochemical effects very well, at either the micro or the macro level.

There are drugs that target lipid and carbohydrate pathways, to be sure, but these are generally small-molecular inhibitors of enzymes that process the compounds. Making compounds that bind to protein sites like those is something we’ve learned a lot about of the years, but compounds that bind directly to complex carbohydrates or to lipids are far more uncommon.

So we have a bit of a blind spot when it comes to both classes of compounds. That blindness is in no small part technological, because it’s been easier to develop tools to analyze, modify, and synthesize proteins and nucleic acids. But we shouldn’t let that make us think that lipids and carbohydrates are somehow ancillary, just because we can’t manipulate them as well. That’s our problem – not theirs.

What Does a Hybrid Telehealth Care Model Look Like?

Hybrid healthcare has been predominant during the pandemic, and telehealth has shown great promise in bringing cost-effective healthcare to regions and communities that otherwise might have had less frequent access to facilities and services.
Meanwhile, changes in Centers for Medicare and Medicaid Services reimbursements mean telehealth expansion is here to stay: CMS recently announced 11 new Medicare-reimbursable telehealth services, bringing the total to 144.
Telehealth, long considered a future practice model, has almost overnight become a current practice mode.
Multiple studies conducted…

New insulin report highlights how incentives benefit middlemen, harm patients

The Senate Finance Committee has released a new report detailing findings of their investigation into the role that market dynamics play in the pricing of insulins. The report conclusions further solidify what we already know: perverse incentives in the market drove up insulin costs for patients.

Some key details. Many insulins have experienced significant net price declines in recent years.

World’s poor need action, not Covid ‘vaccine nationalism’, say experts

Nations outbidding each other creates an ‘immoral race towards the abyss’

Pharmaceutical companies should do more to transfer vaccine technology to prevent the poorest countries falling behind in the distribution of Covid-19 vaccines, according to an expert.

The warning came from Dag-Inge Ulstein, the co-chair of the global council trying to speed up access to Covid vaccines for the world’s poor, known as the Act (Access to Covid-19 Tools) Accelerator. Ulstein, Norway’s international development minister, oversees the drive to ensure vaccines reach the poor – the Covax programme.

Increased transparency on the vaccine deals, including the number of vaccines, the delivery date and price.

Full value for money on the collective funds that the world has given to purchase these vaccines for the world’s poorest so they are purchased at cost price, and not to make a profit.

Increased production of vaccines can be boosted internationally by technology transfer and sharing by pharma companies to local and regional manufacturing firms.

Continue reading…

Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA

This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT- Animal Model Qualification Program, DDT- Biomarker Qualification Program, DDT- Clinical Outcomes Assessment [COA] Qualification Program). Numbers are also provided by stage (Initiation Stage, Consultation and Advice Stage, Review Stage and Qualified).

Biden administration – What can the healthcare industry expect?

As Joe Biden takes the reins at the White House, pharmaphorum asks experts how his presidential tenure may influence the global healthcare industry.

“I think the Biden administration will have only an incremental impact on the healthcare industry as a whole,” said Maxim Jacobs, CFA, managing partner and director of research at Edison Group.

“With a slim majority in the House and an evenly divided Senate it will be tough for him to get anything radical through Congress.  He ran on protecting and expanding Obamacare and I think that is probably what he will try to do. He’ll be able to protect it but I’m not sure about his ability to expand it or enact things like the public option.”

Given other challenges in the US that need to be dealt with first – such as the COVID-19 response, additional Medicaid funding and economy and tax reform – dramatic changes are unlikely, said Mark Brewer, life sciences research director for finnCap.

“Sweeping healthcare reform, in the way that it was prioritised in the Obama administration, is unlikely to be top of the agenda, partly also due to the narrow majority that the Democrats have in the House of Representatives and the Senate and the time/effort that would be required to try and push through such legislation without any guarantee of success. We don’t believe there will be draconian price cuts, for the same reason.

“The Biden administration could put additional scrutiny on drug prices, but more drastic measures, such as allowing Medicare to negotiate with pharma companies directly, are still unlikely.”

“The industry should continue to prosper with innovation driving new product introductions and consequently valuations. Post-COVID recovery in global healthcare systems should also drive the broader healthcare sector, which should benefit device companies and those focused on elective surgery rates,” said Brewer.

Biden could put additional scrutiny on drug prices but more drastic measures, such as allowing Medicare to negotiate with pharma companies directly, are still unlikely, according to Tim Xu, investment associate at Boston, US-based Arix Bioscience.

“Policy-wise, President Biden will aim to protect and restore Obamacare, which to many remains a band-aid solution to the US’ healthcare problem. It is quite likely that cornerstones of the Affordable Care Act will be found unconstitutional by the Supreme Court, such as the individual mandate.

“As ever, it takes a “supermajority” of over 60 votes to get any major legislation through the Senate, so longer-term Democratic wishlist items like a public option or single payer are unlikely. What this means for the pharma industry is likely business as usual, at least until the midterm elections in 2022.”

Generic and opioid-alternative companies could benefit from expanded coverage, if Biden changes policy, according to analysts at Jefferies. In the EU, pharmaceutical companies like Roche could have the largest exposure to Medicare Part B drug reforms due to the proportion of its products that are either IV infused or administered in the physician’s office.

“Some of this apparent threat is already de-risked, given biosimilar erosion of Rituxan, Herceptin and Avastin which have wider pricing disparities ex-US than the newer launches at more competitive prices such as Ocrevus, Hemlibra and Tecentriq. Ex-US stocks with less Part B exposure are Novo Nordisk, Novartis and GSK,” said Jefferies’ Peter Welford.

One area where Biden might be able to make a big difference is pandemic preparation, according to Jacobs. “COVID has been a global disaster and unfortunately there are other pathogens that can be as or more deadly. He’ll probably want greater investment in biodefense so the country can increase its stockpile ahead of the next pandemic event, which may increase industry focus on vaccines, antivirals and antibiotics.”

Science first

While Donald Trump had a strained relationship with the scientific community, Biden is keen to strengthen its position.  This support could help the US preserve its reputation for being at the forefront of research, science and innovation. “It is very clear that Biden is using science and not public opinion to drive change,” ImaginAb CEO, Ian Wilson told pharmaphorum.

“He has publicly stated he expects newly appointed presidential science adviser and the director of the Office of Science and Technology Policy (OSTP), Eric Lander and his team to address questions about the future of science and technology and recommend how his administration can combat public health threats, mitigate the impact of climate change, keep the country a world leader in innovation, use science to improve social equity, and strengthen the US research enterprise.

“This is the first time in history the science adviser will be a cabinet-level position. That, along with the 100 day promise to immunise 100 million people, increased stimulus packages to ensure biotech companies and smaller businesses can ride out the pandemic, and a focus on making the US a leader once again in medical science, gives hope for a new beginning.”

The post Biden administration – What can the healthcare industry expect? appeared first on .

Biden likely to ditch Trump’s plans to relax digital health regulations

President Joe Biden looks likely to ditch the previous administration’s move to create a quicker route to market for digital health products and other devices following the pandemic emergency.

After he took office on Wednesday, Biden quickly moved to freeze a raft of Trump policies, including the moves to loosen regulations on devices including digital health products.

Only last week, the FDA had posted plans with the US Department of Health and Human Services (HHS) to allow certain medical devices including “low risk” digital health apps to be exempt from its usual premarket notification requirements.

The regulatory process known as 510(k) had been temporarily waived during the COVID-19 emergency and the proposal would have made the move permanent.

It was part of a plan to create a fast route to market for products that have helped to support the US health system during the COVID-19 crisis.

The 510(k) process already gave considerable regulatory leeway for new products, allowing the FDA to wave products through to market that it found to be “substantially equivalent” to another legally marketed predecessor.

But it looks like the Biden administration is taking a more long-term view about the regulations and how they apply to digital health.

Legal experts from the law firm Hogan Lovells noted that the proposals to drop the process “fly in the face” of an action plan to regulate artificial intelligence (AI) in healthcare.

That called for an expanded regulatory framework for machine learning devices and a more careful review of products that rely on AI.

The team from Hogan Lovells said that the exemptions remain in place for seven of the devices, all of which are gloves.

But the proposal will not take effect regarding 83 other devices unless the Biden administration decides to pursue it.

Filings for the kinds of devices covered by the notice are still being submitted and accepted by the FDA and meanwhile the HHS is still accepting comments on ways to improve the premarket approval process known until 16 March.

The post Biden likely to ditch Trump’s plans to relax digital health regulations appeared first on .

MHRA and vaccine makers in talks over new Covid variants

Scientists start work on steps needed for potential rapid development of a modified vaccine, AstraZeneca says

The UK medicines regulator is in discussions with coronavirus vaccine manufacturers about “potential modifications” that may be needed to ensure their jabs protect against new variants of the virus.

The Medicines and Healthcare products Regulatory Agency (MHRA) said there was no evidence that vaccines failed to work against the new variants that emerged in recent months, but said it had made the issue a priority.

Continue reading…

Therma Fisher Acquires Rapid COVID-19 Test Provider Mesa Biotech for $450M

Therma Fisher Acquires Rapid COVID-19 Test Provider Mesa Biotech for $450M

What You Should Know:

Thermo
Fisher Scientific Inc.
has entered into a definitive agreement to acquire
Mesa Biotech, Inc., a San Diego,
CA-based molecular diagnostic company, for approximately $450 million in cash.
Under the terms of the agreement, Thermo Fisher will pay up to an additional
$100 million in cash upon the completion of certain milestones following the
close of the transaction.

– Mesa Biotech designs, develops, manufactures, and commercializes next generation Rapid PCR tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC).

– Mesa Biotech’s Accula™ SARS-CoV-2 test was among the first
POC tests to obtain Emergency Use Authorization, providing results within 30
minutes, with higher accuracy than other rapid tests on the market.

– The company has approximately 500 employees and reported
$45M in revenue in 2020.

Leveraging Technology and Data for COVID-19 Vaccine Distribution

Leveraging Technology and Data for COVID-19 Vaccine Distribution
Kevin Grauman, President and CEO, QLess

After months of uncertainty, hope is finally on the horizon as three viable COVID-19 vaccine candidates are moving closer towards approvals for public distribution. Getting to this stage was extremely labor-intensive, but unfortunately, it’s not the end of the hardships. The coronavirus vaccine will represent the largest vaccine distribution in U.S. history, and manufacturing and distributing the vaccines will have its own fair share of difficulties for healthcare systems. In order to optimize the distribution of vaccines, healthcare providers will need to employ technology and data collection to stay organized. Unfortunately, vaccine approvals are quickly looming, meaning that the necessary technology infrastructure needs to be implemented soon. Healthcare facilities need to understand what solutions can be deployed to facilitate a safe and efficient distribution plan — and how to implement them before it’s too late. 

Vaccine Organization and Distribution

With three potential vaccines, each with different vaccination schedules and side effects, managing distribution will be a complicated effort. Patients will need to be matched to the appropriate vaccine, with consideration paid to medical history. Once a patient is matched to their vaccine, healthcare providers need to track side effects, and in the cases of Pfizer and Moderna, when the patient will receive their second dose. This requires significant data collection, which may leave healthcare providers vulnerable to cybersecurity threats. Data breaches have increased by 171 percent this year due to the pandemic, meaning that cybersecurity and secure data storage need to be at the forefront of any healthcare IT strategy.

The CDC is working to implement a data use agreement to determine which information needs to be reported to various levels of government. This will include information on patient matching, which can help determine how much of each vaccine is being used, the remaining supply and what will need to be ordered. Once these guidelines are in place, healthcare facilities will need to start planning and implementing their cybersecurity strategy. Information sharing will be important over the next few months as the vaccines roll out, but this needs to be balanced with access management to reduce the risk of breaches. Ensure that all members of the team, as well as anyone else who has access to important personal data, understand the risks, as well as the protocols that are in place.

Once vaccines are administered, governments will need to monitor both patients and those who chose not to receive a vaccine closely. Shots are voluntary, which means that there may be parts of the population that refuse to get vaccinated. Many governments and businesses are already discussing the implications of that, including restricting access to things like travel and communal spaces. This means that further data will need to be collected and shared that can inform the public of who is not vaccinated. In the U.K., there has been discussion of an app, similar to the contact tracing app, that discloses the status of a person’s vaccination. In Canada, they have discussed an immunity and vaccination passport. It remains to be seen what route the U.S. government will choose, but there are clear implications for data collection with these new technologies.  

Technology Implementation 

Vaccine distribution will also cause problems for healthcare providers due to the sheer volume of patients needing access to services. Currently, hospitals are overwhelmed with COVID-19 patients. It is also flu season, meaning that flu vaccine appointments are rising. In order to provide safe distribution of the flu vaccine, many governments have implemented an appointment-only system where all patients have to pre-register to receive their dose. Similar systems will be crucial for the distribution of COVID-19 vaccinations in order to support the observance of physical distancing requirements. With clinics and healthcare facilities already strained, adding more patients that require vaccinations could cause many issues. Appointments need to be closely managed to ensure that healthcare facilities will still be able to operate safely. Healthcare providers will also need to monitor the number of patients during each distribution phase to ensure that they can handle everyone who needs a vaccine. 

Vaccine distribution could begin any day, which means that the technology infrastructure to support the initiative needs to be implemented immediately. This doesn’t leave much time to create new solutions, so healthcare facilities will need to work with existing technology providers to create a secure infrastructure that supports distribution. When selecting a technology provider, careful consideration needs to be paid to both the services it provides and the security protocol that it has in place. Choose trusted vendors that have experience in the healthcare industry. With all healthcare providers going through the same experience, information sharing will also be important. Discuss with other healthcare IT departments what solutions and providers they are considering for vaccine distribution. 

Preparing for Distribution

There is no doubt that this vaccine distribution plan will be unlike anything the U.S. has ever experienced. With distribution broken down into phases to determine the priority of who receives the vaccines, healthcare providers will be forced to contend with sick patients at the same time that they are distributing vaccines. This will require extra effort to keep everyone safe and healthy. With the vaccines set to begin distribution at any moment, healthcare providers need to act quickly to ensure that the necessary technology and data collection infrastructure is in place to facilitate a safe and efficient distribution.


About Kevin Grauman
Kevin Grauman is the President and CEO of QLess, a line management system used by retail, education and government industries. He is no stranger to the world of startups, with a proven track record as a successful U.S.-based executive leader and entrepreneur. Kevin has been recognized as one of the “100 Superstars of HR Outsourcing in the USA” by HRO Today Magazine.


New Resources Track State Vaccinations by Race/Ethnicity and Examine Demographics of Health Workers

A new Policy Watch, Early State Vaccination Data Raise Warning Flags for Racial Equity, explores the latest state-reported data on vaccination by race/ethnicity available on KFF’s COVID-19 state data and policy tracker. As of January 19, 2021, 17 states were reporting some vaccination data by race/ethnicity, including 16 states reporting the distribution of vaccinations byMore

Eris Lifesciences Ltd-Requirements for Production (OSD)/ QC/ Packing Dept. Apply Now

Eris Lifesciences Ltd-Requirements for Production (OSD)/ QC/ Packing Dept. Apply Now

Job Description

Urgent requirements for Production ( OSD)/QC/Packing departments @ Eris Lifesciences Ltd.
Job Location- Guwahati (Assam).
Job Ported date-  21/ 01/ 2021
Last Date- 25/01/2021.

Production (OSD)/Packing- Officer, Sr. Officer, Executive.
Quality Control (RM, HPLC, GC)-  Sr. Officer, Officer.
Experience required – 1 Year to 8 Years
Qualification- B.Sc, M.sc, B. Pharma, M. Pharmacy.

Packing/OSD Manufacturing Operator – Compression, Coating, Granulation, Capsule filling( Specially for AF40T) .
Packing Operator – Blister, Alu- Alu, Strip.
Experience Required – Minimum- 5 Years.
Qualification- Minimum 10th Qualified.

Interested candidates may send their updated CVs at [email protected] / [email protected]
Interview mode- Telephonic 📞
Thanks
Sunil Prajapati
Human Resources

Eris Lifesciences Ltd-Requirements for Production (OSD)/ QC/ Packing Dept. Apply Now

PharmaShots Weekly Snapshots (Jan 18 – 22, 2021)

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

Published: Jan 22, 2020 | Tags: Takeda, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC

MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the US

Published: Jan 22, 2020 | Tags: MTPA, Aquestive ,Sign ,License ,Supply Agreement, Exservan (riluzole) ,Treat, ALS ,US

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

Published: Jan 22, 2020 | Tags: ViiV ,Cabenuva (cabotegravir and rilpivirine), Receives ,US, FDA Approval, First and Only Complete, Long-Acting ,Regimen, HIV, treatment

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

Published: Jan 22, 2020 | Tags: Eli Lilly, Reports, Results, Bamlanivimab (LY-CoV555), P-III, BLAZE-2 Study, Preventing, COVID-19, Nursing Homes

Servier and MiNA Therapeutics Collaborate to Develop saRNA Therapies for Neurological Diseases

Published: Jan 22, 2020 | Tags: Servier , MiNA Therapeutics, Collaborate ,Develop ,saRNA Therapies ,Neurological Diseases

Boston Scientific to Acquire Preventice for ~$1.2B

Published: Jan 22, 2020 | Tags: Boston, Scientific, Acquire, Preventice ,~$1.2B

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Published: Jan 21, 2020 | Tags: Roche, Reports, US, FDA, Acceptance ,sNDA ,Granted ,Priority Review ,Esbriet (pirfenidone),Treat ,UILD

Qiagen’s PCR Tests Demonstrate Effectiveness in Detecting Mutations in SARS-CoV-2 Virus

Published: Jan 21, 2020 | Tags: Qiagen’s, PCR Tests, Demonstrate ,Effectiveness ,Detecting Mutations ,SARS-CoV-2 Virus

Haemonetics to Acquire Cardiva Medical for ~$510M

Published: Jan 21, 2020 | Tags: Haemonetics, Acquire ,Cardiva Medical,  ~$510M

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Published: Jan 21, 2020 | Tags: Bayer, Merck, Verquvo (vericiguat) ,Receives ,US ,FDA, Approval, Treat, Chronic Heart Failure

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

Published: Jan 21, 2020 | Tags: MacroGenics, Margenza (margetuximab-cmkb), Receives, US, FDA, Pretreated, Metastatic HER2-Positive Breast

Urovant’s Gemtesa (Vibegron) Receives the US FDA’s Approval for Overactive Bladder 

Published: Jan 21, 2020 | Tags: Urovant, Gemtesa (Vibegron) ,Receives, US, FDA, Approval, Overactive Bladder

Merck KGaA and GSK’s Bintrafusp Alfa Fails to Meet its Co-Primary Endpoints in Lung Cancer Study

Published: Jan 21, 2020 | Tags: Merck KGaA, GSK, Bintrafusp Alfa, Fails, Meet, Co-Primary Endpoints, Lung Cancer, Study

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

Published: Jan 21, 2020 | Tags: Vanda,Hetlioz (tasimelteon) ,Receives, US, FDA, Approval, Nighttime Sleep Disturbances ,Smith-Magenis Syndrome

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

Published: Jan 21, 2020 | Tags: Ridgeback, Ebanga (mAb114), Receives, US, FDA, Approval , Treatment, Ebola

Sorrento Presents Preliminary Results of STI-2020 Against COVID-19

Published: Jan 20, 2020 | Tags: Sorrento, Presents, Preliminary, Results, STI-2020, COVID-19

Biohaven’s Troriluzole Fails to Meet its Co-Primary Endpoints in P-II/III Study for Alzheimer’s Disease

Published: Jan 20, 2020 | Tags: Biohaven, Troriluzole, Fails, Meet, Co-Primary Endpoints, P-II/III, Study, Alzheimer’s Disease

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU’s Approval for the HER2 Positive Metastatic Breast Cancer

Published: Jan 20, 2020 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu (trastuzumab deruxtecan), Receives, EU, Approval, HER2 Positive, Metastatic Breast Cancer

Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA

Published: Jan 20, 2020 | Tags: Omeros, Reports, US, FDA, Acceptance ,Priority Review , BLA Narsoplimab (OMS721) ,Treat, HSCT-TMA

Thermo Fisher to Acquire Mesa Biotech for $450M

Published: Jan 20, 2020 | Tags: Thermo Fisher, Acquire, Mesa Biotech, $450M

Lilly and Merus Collaborate to Discover Novel T-Cell Re-Directing Bispecific Antibodies

Published: Jan 20, 2020 | Tags: Lilly, Merus ,Collaborate ,Discover, Novel T-Cell, Re-Directing, Bispecific Antibodies

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

Published: Jan 20, 2020 | Tags: Biocryst, Orladeyo (berotralstat), Receives, US, FDA, Approval, Prevent ,Attacks, Hereditary Angioedema (HAE)

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

Published: Jan 20, 2020 | Tags: Myovant, Orgovyx (relugolix), Receives, US, FDA, Approval, First Oral, GnRH Receptor Antagonist, Advanced, Prostate Cancer

Philips to Acquire Capsule Technologies for ~$635M

Published: Jan 19, 2020 | Tags: Philips, Acquire, Capsule Technologies, ~$635M

Innovent Out Licenses Byvasda’s (biosimilar, bevacizumab) Development and Commercialization Rights to PT Etana in Indonesia

Published: Jan 19, 2020 | Tags: Innovent, Out Licenses, Byvasda’s (biosimilar, bevacizumab), Development, Commercialization Rights, PT Etana, Indonesia

Grifols to Evaluate New Immunoglobulin Therapy Against COVID-19 in Spain

Published: Jan 19, 2020 | Tags: Grifols, Evaluate, New Immunoglobulin Therapy, COVID-19, Spain

Janssen Signs a Research Agreement with TenNor to Develop Treatments for Nontuberculous Mycobacteria Diseases

Published: Jan 19, 2020 | Tags: Janssen, Signs, Research Agreement, TenNor, Develop, Treatments, Nontuberculous Mycobacteria Diseases

Tessa’s CD30 CAR-T Therapy Receives EMA’s PRIME Designation for Relapsed or Refractory Classical Hodgkin Lymphoma

Published: Jan 19, 2020 | Tags: Tessa, CD30 CAR-T Therapy, Receives, EMA, PRIME Designation, Relapsed or Refractory Classical Hodgkin Lymphoma

Boehringer Ingelheim Collaborates with Cure Genetics to Develop Next-Generation Liver-Targeted Gene Therapy

Published: Jan 19, 2020 | Tags: Boehringer Ingelheim, Collaborates, Genetics, Develop, Next-Generation, Liver-Targeted, Gene Therapy

Nanobiotix Presents Results of NBTXR3 (PEP503) in P-Ib/II Study for Rectal Cancer at ASCO-GI 2021

Published: Jan 18, 2020 | Tags: Nanobiotix, Presents, Results, NBTXR3 (PEP503), P-Ib/II , Study, Rectal Cancer, ASCO-GI 2021

Cardiff Oncology Report Results of Onvansertib in P- Ib/II Study for KRAS-Mutated Metastatic Colorectal Cancer

Published: Jan 18, 2020 | Tags: Cardiff Oncology, Report, Results, Onvansertib, P- Ib/II, Study, KRAS-Mutated, Metastatic, Colorectal Cancer

Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Published: Jan 18, 2020 | Tags: Genmab, Darzalex Faspro (daratumumab and hyaluronidase-fihj), Receives, US, FDA, Approval, Patients, Newly Diagnosed, Light-chain,(AL) Amyloidosis

Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer

Published: Jan 18, 2020 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, Receive, US, FDA, Approval, Previously, Treated, HER2-Positive, Advanced, Gastric Cancer

AstraZeneca’s Imfinzi (durvalumab) New Dosing Option Receives Approval for NSCLC in the EU & UK

Published: Jan 18, 2020 | Tags: AstraZeneca, Imfinzi (durvalumab), New Dosing Option, Receives, Approval, NSCLC, EU, UK

GSK Presents Results of Dostarlimab in P-I GARNET Study for dMMR Solid Cancers at ASCO GI

Published: Jan 18, 2020 | Tags: GSK, Presents, Results, Dostarlimab, P-I, GARNET, Study,dMMR, Solid Cancers, ASCO GI

Related Post: PharmaShots Weekly Snapshots (Jan 11- 15, 2021)

The post PharmaShots Weekly Snapshots (Jan 18 – 22, 2021) first appeared on PharmaShots.

Disrupt Podcast #40: John Driscoll of CareCentrix

The 40th episode of our podcast, Disrupt, is now available!

For this episode of Disrupt, Home Health Care News sat down with CareCentrix CEO John Driscoll to talk about emerging health care trends and his company’s plans for 2021.

Originally founded in 1996 by major home health provider Gentiva, CareCentrix is a national at-home care organization that manages more than 26 million lives across over 8,000 provider locations.

Listen to this episode of Disrupt to learn:

— Why payer perceptions of home-based care are starting to change
— How CareCentrix plans on growing in the year ahead
— What consumers want from in-home care providers in 2021
— And more!

Subscribe to Disrupt to be notified when new episodes are released. Listen today!

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Sponsored by

The post Disrupt Podcast #40: John Driscoll of CareCentrix appeared first on Home Health Care News.

Gilead says Veklury should work against COVID-19 variants

Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the UK and South Africa.

According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible shouldn’t affect the way Veklury (remdesivir) works.

The UK strain – known as  B.1.1.7 or VOC 202012/01 – has already been reported in dozens of countries around the world and is estimated to be somewhere between 50% and 70% more infectious than the original strain of SARS-CoV-2.

Last week, the Centers for Disease Control and Prevention (CDC) warned of rapid growth of the variant in coming weeks and said it could become the dominant strain in the US within weeks.

The South African variant B.1.351 (also known as 501Y.V2) meanwhile is also spreading around the world and is estimated to be 50% more transmissible.

So far, neither variant seems to be associated with more severe COVID-19 symptoms, although there has been some preliminary research suggesting the SA strain could allow reinfection with SARS-CoV-2, and also be less susceptible to vaccines. This week, Pfizer and BioNTech said their Comirnaty shot seemed to retain efficacy against the UK variant.

“The mutations identified in these new variants have not significantly altered the part of the virus that remdesivir targets or have any association with known mutations conferring reduced susceptibility of coronaviruses to remdesivir in vitro,” said Gilead in its statement.

“We continue to conduct additional research to evaluate newly emerging variants and to further understand their potential impact on remdesivir,” it added.

Veklury is currently the only antiviral drug licensed for the treatment of COVID-19 and works by interfering with a polymerase enzyme central to the production of viral RNA particles.

There has been no evidence of resistance to the drug in SARS-CoV-2, although that was observed in experiments involving Ebola, the viral disease for which it was originally developed.

Scientists have suggested that – theoretically at least – SARS-CoV-2 could see similar changes in polymerase that could reduce Veklury’s efficacy.

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Nearly 6 in 10 Older Americans Don’t Know When or Where They Can Get a COVID-19 Vaccine; Black and Hispanic Adults among the Groups Least Likely to Have Enough Information

Despite Optimism about COVID-19 Vaccines in the Future, Half Say They are Frustrated with the Current Situation and Nearly a Quarter are Angry While older Americans are a high-priority group for getting a COVID-19 vaccine, the latest KFF COVID-19 Vaccine Monitor report finds that, among those who have not yet been vaccinated, most people ages 65 andMore

Top 20 Life Sciences Deals of 2020 by Total Deal Value

  • Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020
  • Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal value of $6.9B. The second-highest deal valued at $6B was Daiichi Sankyo’s development and commercialization deal with AstraZeneca for DS-1062
  • This article is based on the 2020 biotech and pharma deals data as provided by Chris Dokomajilar of DealForma. Our team at PharmaShots curated the top 20 deals in healthcare and life sciences by disclosed total deal value in R&D partnerships

20. insitro’s Development and Commercialization Deal with Bristol Myers Squibb

Deal Date: Oct 28, 2020

Deal Value: $2.07B

insitro granted Bristol Myers Squibb rights to develop and commercialize therapies for the treatment of amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). insitro will apply its platform, the insitro Human (ISH) platform, to generate induced pluripotent stem cell (iPSC) derived disease models for ALS and FTD to provide insights into disease progression after which BMS has the option to select a few targets for further clinical development and commercialization. Insitro received $50M up front and is eligible for up to $20M in operational and up to $2B in discovery, development, regulatory, and commercial milestones, plus royalties.

19. Silence Therapeutics’ Development and Commercialization Deal with AstraZeneca

Deal Date: Mar 25, 2020

Deal Value: $2.08B

Silence Therapeutics granted AstraZeneca rights to develop and commercialize 5 liver-based small interfering RNA (siRNA) therapies for cardiovascular, renal, metabolic, and respiratory diseases using Silence’s established GalNAc-siRNA platform. AstraZeneca and Silence will conduct discovery research on the 5 targets during a 3-year research period. Silence is responsible for designing siRNA molecules against gene targets selected by AstraZeneca, and for manufacturing of material to support GLP toxicology studies and Phase I clinical studies. AstraZeneca will lead clinical development and commercialization. AstraZeneca has the option to extend the partnership for a further 5 targets. Silence has the option to co-develop 2 programs of their choice starting from Phase II. Silence received $60M up front, a $20M upfront equity investment, a potential $10M option fee for each selected target, and is eligible for up to $140M in development milestones and up to $250M in commercial milestones for each target, plus high single-digit to low double-digit tiered royalties.

18. UCB’s Research Partnership with Roche and Genentech with an Option to License for UCB0107

Deal Date: July 29, 2020

Deal Value: $2.12B     

UCB granted Roche and Genentech an exclusive, worldwide option to license the development and commercialization of UCB0107 for the treatment of progressive supranuclear palsy (PSP) and Alzheimer’s Disease. UCB will fund and conduct a proof-of-concept study in Alzheimer’s Disease after which Genentech has the option to either progress with the development or return full rights to UCB. UCB received $120M up front. If Genentech exercises its option, UCB is eligible to receive up to $2B in cost reimbursement, development, and sales-based milestones, plus royalties.

17. Denali’s Development and Commercialization Deal with Biogen for DNL151

Deal Date: Aug 6, 2020

Deal Value: $2.15B

Denali granted Biogen rights to co-develop and co-commercialize Denali’s small molecule leucine-rich repeat kinase 2 (LRRK2) inhibitor program, DNL151, for the treatment of Parkinson’s disease. Additionally, Biogen has an exclusive option to license up to 2 preclinical programs including its Antibody Transport Vehicle (ATV), Abeta program (ATV enabled anti-amyloid beta program), and a second program utilizing its TV technology. Biogen also has the right of first negotiation on 2 additional TV-enabled therapeutics. Both companies will co-commercialize DNL151 in the US and China. Denali received $560M up front, $465M as an equity investment, and is eligible for up to $1.125B in development and commercial milestones for DNL151, plus royalties. Biogen and Denali will share responsibility and development costs on a 60:40 basis globally, share costs, profits, and losses 50:50 in the US, and 60:40 in China for the LRRK2 program.

16. Skyhawk’s Research Partnership with Vertex with an Option to License Small Molecules

Deal Date: December 22, 2020

Deal Value: $2.24B

Skyhawk signed a research partnership with Vertex to develop small molecule therapies that modulate RNA splicing using Skyhawk’s SkySTAR platform for the treatment of neurodegenerative diseases and cancer. Vertex has a worldwide option to license intellectual property rights to compounds developed under the collaboration. Skyhawk will receive $40M up front and is eligible for up to $2.2B in milestones, plus royalties if Vertex exercises the option.

15. Kymera Therapeutics’ Development and Commercialization Deal with Sanofi for Inflammatory Diseases

Deal Date: July 9, 2020

Deal Value: $2.33B

Kymera granted Sanofi exclusive, worldwide rights to develop and commercialize 2 programs outside of oncology/immuno-oncology: a preclinical IRAK4 lead compound for immune-inflammatory diseases and an earlier stage program for an undisclosed use. Kymera is responsible for discovery and preclinical research and conducting a Phase 1 trial for at least 1 protein degrader directed against IRAK4, plus up to 3 backup degraders. Sanofi will be responsible for further clinical development and commercialization and will also be responsible for all clinical development activities for the second program. Kymera has the option to co-develop and co-commercialize both programs in the US and share all the costs and profits equally. Kymera will receive $150M up front and is eligible for up to $1.48B in the development milestones (more than $1B of the $1.48B relates to IRAK4 dev. and reg. events), up to $700M in sales milestones ($400M of the $700M relates to IRAK4), plus tiered royalties from the high single digits to high teens, subject to low-single digits upward adjustments in certain circumstances.

14. Taiho and Astex’s Development and Commercialization Deal with Merck

Deal Date: Jan 6, 2020

Deal Value: $2.55B

Taiho and Astex granted Merck exclusive, worldwide rights to develop and commercialize Taiho and Astex’s combined small molecule and data for the treatment of cancer. Taiho and Astex received $50M up front, undisclosed R&D funding, and are eligible for up to $2.5B in milestones, plus royalties. Also, Taiho has co-commercialization rights in Japan and an option to promote in specific areas of South East Asia.

13. Nurix’s Development and Commercialization Deal with Sanofi for Cancer

Deal Date: Jan 9, 2020

Deal Value: $2.58B

Nurix granted Sanofi exclusive, worldwide rights to develop and commercialize immuno-oncology therapeutics discovered by Nurix using its DELigase platform. Nurix’s drug discovery platform integrates DNA-encoded libraries and a portfolio of E3 ligases to create small molecules designed to induce protein degradation of drug targets. Nurix granted Sanofi 3 specific targets and Sanofi has the option to expand to 5 targets. Sanofi is responsible for clinical development and commercialization. Nurix has the option to co-develop and co-promote up to 2 products in the US under certain conditions. The partnership excludes Nurix’s lead degradation programs for which Nurix retains all rights. Nurix received $55M up front, undisclosed option payments for additional targets, and is eligible for up to $2.5B in total payments including undisclosed research, preclinical, clinical, regulatory, and sales milestones. If Nurix exercises its option to co-develop and co-promote certain products, the partners will split US profits and losses for those products 50/50. Nurix to receive undisclosed royalties on ex-U.S. net sales on all optioned products. In January 2021, Nurix received $22M following Sanofi exercising its option for a total of five targets.

12. Precision BioSciences’ Development and Commercialization Deal with Eli Lilly

Deal Date: Nov 20, 2020

Deal Value: $2.66B

Precision BioSciences granted Eli Lilly exclusive rights to develop and commercialize in vivo therapies for genetic disorders with the initial focus on Duchenne muscular dystrophy and 2 undisclosed gene targets by applying Precision’s ARCUS genome editing platform. Eli Lilly will have an option to expand the partnership to 3 additional targets. Precision BioSciences received $100M up front, $35M in an upfront equity purchase of its common stock, and is eligible for up to $420M per product in development, regulatory, and sales milestones (up to $2.52B for 6 targets), plus tiered royalties ranging from the mid-single digits to low-teens.

11. Sangamo’s Development and Commercialization Deal with Biogen

Deal Date: Feb 27, 2020

Deal Value: $2.72B

Sangamo granted Biogen exclusive, worldwide rights to develop and commercialize gene regulation therapies, including ST-501, for the treatment of tauopathies, including Alzheimer’s disease, ST-502 for the treatment of synucleinopathies, including Parkinson’s disease, a third undisclosed neuromuscular disease target, and up to nine additional undisclosed neurological disease targets using Sangamo’s zinc finger protein (ZFP) technology. Sangamo received $125M up front, $225M in upfront equity for approximately 24M shares at $9.21 per share, and is eligible for up to $2.37B in milestones, plus royalties.

10. Schrodinger’s Development and Commercialization Deal with BMS

Deal Date: Nov 23, 2020

Deal Value: $2.76B

Schrodinger granted BMS exclusive, worldwide rights to develop and commercialize small molecule therapeutics for the treatment of cancer, autoimmune, and neurologic diseases using Schrodinger’s physics-based computational platform. Schrodinger received $55M up front and is eligible for up to $2.7B in preclinical, development, regulatory, and sales milestones, plus royalties.

09. Repare’s Development and Commercialization Deal with BMS for Oncology

Deal Date: May 26, 2020

Deal Value: $3.06B     

Repare granted BMS exclusive, worldwide rights to develop and commercialize multiple oncology products using Repare’s SNIPRx synthetic lethal discovery platform for the treatment of cancer. Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from therapies based on the genetic profile of their tumors. Repare received $65M up front comprised of $50M in cash and $15M in an upfront equity investment and is eligible for up to $3B in license fees and milestone payment, plus royalties.

08. Fate Therapeutics’ License Option Deal with Janssen Biotech for Cancer

Deal Date: Apr 2, 2020

Deal Value: $3.1B

Fate Therapeutics granted Janssen exclusive, worldwide option to develop and commercialize up to four iPSC-derived chimeric antigen receptor (CAR) NK and CAR T-cell therapies using Fate’s iPSC product platform for the treatment of hematologic malignancies and solid tumors. Janssen will reimburse development cost until IND after which Janssen has the right to exercise its option. Fate received $50M up front, a $50M upfront equity investment at $31.00 per share, and is eligible for up to $1.8B in development and regulatory milestones and up to $1.2B in commercial milestone, plus double-digit royalties. Additionally, Fate has the option to co-commercialize and share equally in profits and losses in the US in place of certain clinical development costs and adjustments in milestone and royalty payments.

07. Sage Therapeutics’ Development and Commercialization Deal with Biogen

Deal Date: Nov 27, 2020

Deal Value: $3.12B

Sage Therapeutics granted Biogen exclusive rights to develop and commercialize zuranolone for the treatment of the major depressive disorder (MDD), postpartum depression (PPD), and other psychiatric disorders, and SAGE-324 for the treatment of tremor and other neurological disorders outside the US excluding rights to zuranolone in Japan, Taiwan, and South Korea. Sage received $875M in upfront cash and $650M in upfront equity in exchange for approximately 6.2M newly issued shares of Sage common stock at $104.14 per share and is eligible for up to $1.6B in development and commercial milestones. Both companies will equally share the responsibility and development costs and profits for commercialization in the US, whereas Biogen will be responsible for development and commercialization outside the US excluding Japan, Taiwan, and South Korea for which Sage will receive royalties.

06. Alteogen’s Development and Commercialization Deal with an Undisclosed Company

Deal Date: June 24, 2020

Deal Value: $3.88B

Alteogen granted an undisclosed company non-exclusive, worldwide rights to ALT-B4, Alteogen’s Hybrozyme technology, a hyaluronidase-derived technology used for subcutaneous administration of biologic products which are otherwise administered as an IV injection. The undisclosed company has the right to elect to develop additional products in combination with ALT-B4 upon achievement of a pre-specified milestone. Alteogen will be responsible for regulatory development and commercial supply of ALT-B4. Alteogen received $16M up front and is eligible for up to $3.865B in development, regulatory, and sales-based milestones.

05. Genmab’s Development and Commercialization Deal with AbbVie for Cancer

Deal Date: June 10, 2020

Deal Value: $3.9B

Genmab granted AbbVie worldwide rights to co-develop and co-commercialize three bispecific antibody programs: epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37, and DuoBody-CD3x5T4 using AbbVie’s antibody-drug conjugate (ADC) platform for the treatment of hematological cancers. Additionally, AbbVie has the option to develop four additional antibody-based therapeutics using Genmab’s DuoBody technology and AbbVie’s ADC technology for solid tumors and hematological malignancies. Both companies will be responsible for the co-commercialization of epcoritamab in the US and Japan and will be responsible for the worldwide development and commercialization of DuoHexaBody-CD37, DuoBody-CD3x5T4, and any product candidates developed under the agreement in the US and Japan. Genmab has the right to co-commercialize these products outside of the US and Japan and AbbVie has the right to opt-in to program development. Genmab received $750M up front and is eligible for up to $1.15B in development and commercial milestones for epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37, and DuoBody-CD3x5T4 and up to $2B in success-based milestones for additional antibody product candidates developed under the collaboration, plus 26% royalties for epcoritamab outside the US and Japan. Both companies will share profits on a 50:50 basis.

04. Seagen’s Development and Commercialization Deal with Merck

Deal Date: Sep 14, 2020

Deal Value: $4.2B

Seagen (formerly Seattle Genetics) granted Merck exclusive, worldwide rights to develop and commercialize ladiratuzumab vedotin, a Phase II antibody-drug conjugate targeting LIV-1 for the treatment of cancer. The partners will develop ladiratuzumab as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) in triple-negative breast cancer (TNBC), hormone receptor-positive breast cancer, and other LIV-1-expressing solid tumors. Seagen will be responsible for the marketing applications in the US and Canada and will book sales in the US, Europe, and Canada. Merck will be responsible for the marketing applications in Europe and other territories and will book sales worldwide excluding the US, Europe, and Canada. The partners will share development costs and profit equally. Seagen received $600M in cash and Merck invested $1B in Seagen common stock by purchasing 5M shares at $200.00 per share. Also, Seagen is eligible to receive up to $850M in development milestones and up to $1.75B based on sales performance. The partners will share costs and profits equally.

03. Myovant’s Development and Commercialization Deal with Pfizer for Orgovyx

Deal Date: December 28, 2020

Deal Value: $4.25B

Myovant Sciences granted Pfizer rights to develop and commercialize Orgovyx (relugolix) for prostate cancer and relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women’s health in the US and Canada. Pfizer has an exclusive option to commercialize relugolix in oncology outside the US and Canada, excluding certain Asian countries. Both companies will equally share profits and expenses for Orgovyx and relugolix combination tablets. Myovant will receive $650M up front and is eligible for up to $200M in regulatory milestones for FDA approvals for the relugolix combination tablet in women’s health and up to $3.35B in sales-based milestones upon reaching certain thresholds up to $2.5B. If Pfizer exercises its option, Myovant will receive $50M and will be eligible for double-digit royalties.

02. Daiichi Sankyo’s Development and Commercialization Deal with AstraZeneca for DS-1062

Deal Date: July 27, 2020

Deal Value: $6B

Daiichi Sankyo granted AstraZeneca worldwide rights to develop and commercialize DS-1062, a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) for the treatment of multiple tumors. Both companies will equally share development and commercialization costs and profits worldwide whereas Daiichi Sankyo will be responsible for all costs and will pay mid-single-digit royalties to AstraZeneca for Japan. Daiichi Sankyo received $1B up front and is eligible for up to $1B in regulatory milestones and up to $4B in sales-based milestones.

01. Artios’ Research Partnership with Merck with an Option to License up to 8 Oncology Targets

Deal Date: Dec 3, 2020

Deal Value: $6.9B

Artios signed a research partnership with Merck to discover and develop therapies using Artios’ nuclease targeting discovery platform for the treatment of cancer. Merck has an exclusive, worldwide option to license the development and commercialization of up to 8 cancer targets. Additionally, Artios has opt-in rights for joint development and commercialization with Merck. Artios received $30M in upfront and near-term payments. If Merck chooses to exercise the option, Artios will receive undisclosed option fees and is eligible for up to $860M in milestones for each target, plus royalties.


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Logimed Pharma

  Logimed Pharma Pvt.ltd. Address : Logimed Pharma Pvt.ltd. Shed No.471,first Floor Industrial Area , Phase 1 Panchkula -134109 (Hry.)   Logimed Pharma Pvt. Ltd is a new addition in our franchise business. Our product range comprises of Analgesics, Antibiotics, … Continue reading

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3 Tips On Managing Seasonality and Improving Cash Flow

Ebbs and flows, seasonal highs, and seasonal lows — every industry has them. Whether your business looks towards summer to shine bright, or towards the winter to capitalize on the holiday spending craze, chances are your business experiences some form of seasonality, or periods of slowdowns. 

The ongoing pandemic hasn’t made it any easier: from supply chain disruptions to dips in product demands, businesses are experiencing slowdowns that have taken everyone by surprise. Keeping your business’s cash flow optimized now can help put you in a better position for any future potential disruptions, and sets you up for success. 

We put together three ways your business can better manage seasonality and improve cash flow — let’s get started!  

Give Your Website A New Look 

You don’t need customers to walk through your door to make a sale. Regardless of their distance to you, customers are always online and the ongoing crisis has caused many businesses to move online as well. Because of this, customer expectations regarding the online experience have begun to shift. During periods of slowdowns, it is important for your business to update its website and if possible, provide your customers with an online shopping experience. 

An old, dated website can hurt more than not having a website at all in the eyes of a customer. Consider updating your website to add any information that may be missing, or to simply give it a refresh with new pages. Have an exciting product coming soon? Start a blog on your website and begin advertising it! Recently remodeled the office? Take pictures and upload to your website! 

The key is to always have your website looking ready and full of content for its next visitor to keep them on your site, which will increase the chances of a sale. While your office may have low foot traffic, your business can still maintain productivity with an updated website within the online marketplace. 

While updating your website, use the time as a chance to also further optimize your website to help drive more traffic to it. If your business is appointment based, consider integrating an online appointment tool to provide more accessible options for your customers to take advantage of. Services such as Calendly and Appointment offer free scheduling tools that can be integrated straight into your website. By integrating these, you simplify the process for your customer by keeping them on one page, which will aid in customer satisfaction.

Such online tools go hand-in-hand with video chat services like Zoom, or Google Meet, which provide ways for businesses to continue meeting with their customers in a manner that doesn’t require either party to be inside a store. If your business can host virtual meetings, your customers will want to know, so be sure to update your website to include all forms in which your business makes itself available to its customers. 

Moving online benefits your business in more ways than simply improving your customer’s experience: it helps grow your business. Transitioning online provides additional marketing opportunities such as integrating your social media networks within your website, which establishes an efficient sales funnel for your business. 

Encourage Customers To Buy During Slowdowns

Once your website is up to date, the next step to managing seasonality and cash flow will be to encourage customers to buy during your slowdown. The idea sounds obvious and simple enough, but effectively doing so may require out of the box thinking and creativity. 

The easiest way to encourage more customers to come in will be to offer deals and specials that incentivize customers to buy now. Offering unique specials during off season can give the nudge a customer needs to purchase your products or services. If you’re weary about offering too many discounts during the slow season, there are ways you can do so that will continue to provide your business with various benefits in the long run. 

Consider asking your customers for their email address, and then producing regular newsletters or emails that contain savings exclusive to email subscribers. This way, your business has better control over how many discounts are given out, and also now has a list of contacts to send other marketing materials to for future products or announcements. 

Encouraging your customers to buy during slowdowns will also require you to maintain an active presence on your social networks. Use your social media to keep customers informed of your latest products or services and to remind them of your business. Consider promotional events such as giveaways where you ask customers to share your social pages with their friends for a chance to win prizes: your customers will be happy to win, and you’ll receive free promotion to help bring in more business. 

Your business can further improve its cash flow and seasonality by adding additional revenue streams. Consider encouraging customers to buy when business is slower with customer financing. By providing financing options, your business keeps momentum up during slowdowns through your customer’s recurring monthly payments. A continuous cash flow helps soften the impact faced when slowdowns occur, and keeps you well prepared for when business picks back up. 

Encouraging customers to buy during the slow season with financing options further benefits businesses by providing the opportunity to effectively upsell its customers. By breaking large purchases into manageable payments, customers will be more likely to upgrade to premium services or products at checkout, increasing your revenue stream for that finance contract. 

Improve Payment Processing Efficiency With Technology 

Once your website is updated and you’ve put plans in place to encourage customers to buy, the next step to managing seasonality and cash flow will be to improve efficiency. Consider applying a digital-first approach by modernizing the infrastructure of your payment processing.

Payment processing and invoice software can help minimize the time it takes to collect payments from customers and quickly help to optimize your business’s cash flow. Such software can help to eliminate paper invoices, so businesses reduce the time spent on tedious manual processes such as filing and sending out physical invoices one at a time. 

Adopting a digital-first mindset is also beneficial to your customers. Much like providing an online marketplace improves the customer experience, providing multiple payment options help streamline the payment process, which aids in customer satisfaction. 

A digital shift will also enable your business to accept contactless payments, which a recent survey done by American Express found that over the past year, 11% more consumers now say they prefer using contactless payments. While such a shift is a result of the ongoing pandemic, 81% of the surveyed merchants agree that the practice has been beneficial to their business and will continue to offer contactless payments as a permanent option. 

Using services such as Denefits can help your business quickly transition into offering contactless payments, and more! 

Denefits: Complete Payment Options

Denefits is an innovative complete payment options system that provides businesses in any industry with easy payment solutions and flexible financing options for its customers. 

With Denefits, your business can offer customer financing with no credit check and instant approvals to further encourage customers to buy during slowdowns and increase revenue streams. Denefits also transitions your business towards an electronic invoice system and automates the collection process for you. 

Tired of paying ridiculous merchant fees on credit card transactions? With Denefits, you have the power of choice: to split or pass on the transaction fee with the customer and getting started is a quick and simple process. There are no service fees, nor is there any equipment to install, so your business wastes no time in improving its cash flow with Denefits. 

Key Takeaways

Businesses who optimize their cash flow before slowdowns occur position themselves to better manage any disruptions in the future, or any seasonal periods of slowdowns. Updating your points of contact with customers, such as your website, and integrating new promotional campaigns will help keep customers engaged, and using services such as Denefits can help improve your payment processing efficiency.

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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.

The post Gavi to make 500,000 doses of Ebola vaccine available for outbreak response appeared first on European Pharmaceutical Review.

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. 

The post Fire at Serum Institute of India, production site of COVID-19 vaccine appeared first on European Pharmaceutical Review.

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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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.

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.

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.

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.

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.

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.

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.

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.

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

cbaker_admin
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.”

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.

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

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

cbaker_admin
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.

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.

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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MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the US

Shots:

  • Aquestive will receive upfront, milestones, royalties on net sales for Exservan (oral film formulation) in the US and will earn revenue pursuant to the exclusive supply agreement
  • MTPA to commercialize Exservan in the US while Aquestive will serve as the exclusive sole manufacturer and supplier for the product
  • Exservan is an oral film formulation of riluzole, expected to be available in the mid of 2021

Click here ­to­ read full press release/ article | Ref: MTPA | Image: PR Newswire

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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.”

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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

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

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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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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

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Servier and MiNA Therapeutics Collaborate to Develop saRNA Therapies for Neurological Diseases

Shots:

  • MiNA to receive $267.6M in up front, exclusivity fee on first neurological target and will be eligible to receive research, development, regulatory and commercial milestones along with royalties
  • Servier will lead pre/ clinical development of lead candidates and will have the rights to commercialize any products that emerges from the collaboration
  • The collaboration integrates Servier’s CNS expertise and MiNA’s small activating RNA technology to identify new potential treatments for restoring normal cell function in neurological disorders

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

The post Servier and MiNA Therapeutics Collaborate to Develop saRNA Therapies for Neurological Diseases first appeared on PharmaShots.

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.

USPTO Responds to Congressional Request for Information Regarding Criteria for Registration Examination for Admission to Patent Bar

By Donald Zuhn –- On Tuesday, U.S. Patent and Trademark Office Director Andrei Iancu, in one of his last acts before stepping down from the post, sent a letter to Senators Thom Tillis (R-NC), Christopher Coons (D-DE), and Mazie Hirono (D-HI) of the Subcommittee on Intellectual Property for the Senate Judiciary Committee, responding to the Senators’ letter of December 11, 2020 seeking information regarding the criteria for the registration examination for admission to the patent bar. The letter from the Senators sought the Office’s response to the following six questions: 1. What percentage of registered patent practitioners are women? To…

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.