Pharma Update 11-22-21
According to Statusta, by year end 2020, the total global pharmaceutical market was valued at about $1.27 trillion. A significant increase from 2001 when it was valued at $390 billion. The pharmaceutical market plays a key role in how people get medications and what people pay for medication. At the intersection of healthcare, pharma, and technology, here are current news and announcements.
Mergers, Acquisitions, Funding, IPOs, Partnerships, Collaborations
Neumora Explodes onto Neuro Scene with $500 Million and Amgen Alliance
Fresh out of the gates with $500 million in financing, neuroscience-focused Neumora Therapeutics (@NeumoraTx) forged a strategic partnership with Amgen to develop and commercialize assets owned by the pharma giant, targeting casein kinase 1 delta and glucocerebrosidase for neurodegenerative diseases.
Johnson & Johnson Announces Plans to Accelerate Innovation, Serve Patients and Consumers, and Unlock Value through Intent to Separate Consumer Health Business
Johnson & Johnson (@jnjnews) announced its intent to separate the Company’s Consumer Health business, creating a new publicly traded company. The planned separation would create two global leaders that are better positioned to deliver improved health outcomes for patients and consumers through innovation, pursue more targeted business strategies and accelerate growth.
Policy
Biden-Harris Administration Improves Transparency and Oversight of Prescription Drug and Medical Costs
The Biden-Harris Administration took additional steps to lower health care costs by requiring health insurance issuers, employer-based health plans, and other group health plans to report on prescription drug and health coverage costs. The requirement—implemented through an interim final rule with request for comments issued by the Departments of Health and Human Services (HHS), Labor, the Treasury (collectively, the Departments), and the Office of Personnel Management—represents the latest in a series of actions that deliver on President Joe Biden’s commitment to protect millions of consumers long plagued by high health care costs. The rule is the fourth rule in a series that the Departments are issuing to implement the No Surprises Act and transparency requirements of the Consolidated Appropriations Act (CAA), 2021.
USP Releases Newly Proposed <797> Revisions
After almost two years of anticipation, USP (@USPharmacopeia) has issued its new proposed revisions to Chapter <797>, “Pharmaceutical Compounding—Sterile Preparations.” What does this mean for sterile compounding in your pharmacy?
COVID Updates
Today, we amended the EUAs for the Moderna & Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose to be administered to those 18+ years old after completion of a primary vax series with any FDA-authorized/approved #COVID19 vaccine. https://t.co/BpITYtl90d pic.twitter.com/r49GJj5Opo
— U.S. FDA (@US_FDA) November 19, 2021
Friday Five – COVID Update
For last week’s Friday Five we rounded up some of the news and announcements pertaining to COVID-19, the latest statistics, long covid, new COVID medications, and information about the vaccines including who is eligible to receive them, booster shots and CPT codes.
Biden Administration Secures 10 Million Courses of Pfizer’s COVID-19 Oral Antiviral Medicine as Additional Tool to Reduce Hospitalizations and Save Lives
As part of its ongoing efforts to curb the pandemic, reduce hospitalizations, and save lives, the Biden Administration has secured 10 million treatment courses of Pfizer’s promising COVID-19 oral antiviral drug, contingent on emergency use authorization (EUA) or approval from the U.S. Food and Drug Administration (FDA).
HHS Announces $143.5 Million to Expand Community-Based Efforts to Address Barriers to COVID-19 Vaccination
The US Department of Health and Human Services (@hhsgov), through the Health Resources and Services Administration (@HRSAgov), announced $143.5 million in American Rescue Plan funding to expand community-based efforts to conduct tailored local outreach about vaccines, build vaccine confidence and address barriers to vaccination in their communities.
Biden Administration to Invest $650 Million in Rapid Diagnostic Testing in Latest Action to Increase Access to Tests
As part of the Biden-Harris Administration’s ongoing commitment to increasing access to COVID-19 testing for Americans and to further strengthen domestic manufacturing of needed tests, the U.S. Department of Health and Human Services (HHS) will invest $650 million from the American Rescue Plan to strengthen manufacturing capacity for quick, high-quality diagnostic testing through rapid point-of-care molecular tests and increase Americans’ access to them.
As Vaccinations are Approved for Children Across the Country, U.S. Surgeon General Releases New Community Toolkit for Addressing Health Misinformation
As a new phase of the COVID-19 vaccination campaign begins for children ages 5 to 11 years old, U.S. Surgeon General Dr. Vivek Murthy releases a Community Toolkit for Addressing Health Misinformation – PDF to help Americans navigate the serious threat of health misinformation, especially online. Earlier this year, Dr. Murthy issued the first Surgeon General’s Advisory of this administration warning people about the urgent threat of health misinformation and calling for a whole-of-society approach to address it.
Moderna and U.S. at Odds Over Vaccine Patent Rights
Moderna and the National Institutes of Health (@NIH) are in a bitter dispute over who deserves credit for inventing the central component of the company’s powerful coronavirus vaccine, a conflict that has broad implications for the vaccine’s long-term distribution and billions of dollars in future profits.
Twist Bioscience Launches Revelar Biotherapeutics to Develop and Commercialize Novel COVID-19 and Other Antibody Therapeutics for Difficult to Treat Diseases
Twist Bioscience Corporation (@twistbioscience), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, announced it has launched Revelar Biotherapeutics, Inc., an independently operated, new biotechnology company to develop and commercialize an antibody, discovered and optimized by Twist Biopharma, a division of Twist Bioscience, that neutralizes all known variants of concern of the SARS-CoV-2 virus in preclinical studies.
FDA Approvals in the News
FDA Approves Treatment for Rare Blood Disease
The U.S. Food and Drug Administration (@US_FDA) approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The excess cells thicken the blood, slowing blood flow and increasing the chance of blood clots.
News & Noted
COVID-19 Death Toll: More than Just SARS-CoV-2
More than 100,000 people in the United States died from a drug overdose between April 2020 and April 2021—a 28.5% increase, according to provisional data from the National Center for Health Statistics.
To Read
Outpatient Payments in 2022: What’s on the Table by Pharmacy Practice News – Common themes for 2022 include an emphasis on health equity and patient access, with the goal of creating a health care system that results in better accessibility, quality, affordability, empowerment and innovation. The approach of CMS to outpatient reimbursement also touches on multiple facets of health care, from requirements for price transparency to increased reimbursement rates for ambulatory surgery centers (ASCs) and a variety of efforts toward patient safety.
The Patent Slow Dance Trips Up Access to Rx Savings by Pharmacy Practice News – The Biologics Price Competition and Innovation Act (BPCIA), passed by Congress in 2010, aimed to streamline the process of getting biosimilar drugs to market by creating an abbreviated approval pathway for these versions of the original high-priced biologic drugs. Given that potential for savings, where has the process gone awry?
Resources
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
Upcoming Events
FDA Pharmaceutical Labeling Boot Camp
What: FDA Pharmaceutical Labeling Boot Camp
When: December 6-7, 2021
Where: Virtual Event
Register here.
The FDA Pharmaceutical Labeling Boot Camp offers a uniquely deep dive not only into labeling best practices, but in how to align your labeling standards with your overarching marketing compliance strategy.
The 26th Annual ARC Industry Forum Accelerating Industrial Digital Transformation and Sustainability
What: The 26th Annual ARC Industry Forum Accelerating Industrial Digital Transformation and Sustainability
When: February 14 – 17, 2021
Where: Renaissance Orlando at SeaWorld
Register here.
Your mandate is transformation. The target is much better business outcomes. Join us at the 26th Annual ARC Industry Forum to speed up your progress with strategies and stories from the digital front lines.
