Pharma Update 1-17-22
To Listen
Healthcare Upside/Down: US drug prices are the highest in the world host Dr. Nick talks to AJ Loiacono, CEO of Capital Rx.
Based on a 2021 RAND study the US pays 256% more than the combined pricing of 32 comparable countries. These are not different drugs being sold in other countries and the utilization of drugs – how much we as patients or consumers take of these medications, is not substantially different across the different countries either. There are many reasons for this vast discrepancy here in the US. Even the US government – the biggest purchaser of healthcare and drugs has at least 5 different price books for every medication and the situation only gets more complex when you layer on federal and state programs.
Your better pill to swallow is to engage in new models of supply for drugs, insist on transparency and don’t settle for the traditional position, “That’s just the way it’s always been done.” Seek out the disruption and new players in the supply chain who have left behind the old model of a steady and continued increase in costs.
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
Quris Closes $28 Million in Seed Funding From Top Institutional Investors
Quris, an artificial intelligence (AI) innovator disrupting the pharmaceutical arena, announced the final close of $28 million in seed funding – inclusive of the initial $9 million announced late last year with the launch of Quris’s BioAI platform for clinical prediction. Led by Welltech Ventures with participation from iAngels, GlenRock Capital, and others, the funding will fast-track Quris’s novel drug research and development, team expansion and partner-building efforts as it scales to rapidly scan 100s of drug candidates to train its AI engine in its mission to revolutionize the drug development process.
Castle Creek Biosciences Acquires Novavita Thera to Expand Innovative Cell and Gene Therapy Platform
Castle Creek Biosciences, Inc. (@CastleCreekBio), a late-clinical stage cell and gene therapy company focused on developing and preparing to commercialize disease-modifying and potentially curative therapies for rare genetic diseases, announced it has acquired Novavita Thera, Inc., a preclinical gene therapy company focused on rare liver and metabolic diseases. The acquisition expands Castle Creek’s technology platform by adding in vivo capabilities to its existing ex vivo approach, and broadens Castle Creek’s development pipeline beyond skin and connective tissue disorders to rare liver diseases.
Policy
CMS Proposes Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
The Centers for Medicare & Medicaid Services (@CMSGov) released a proposed National Coverage Determination (NCD) decision memorandum. The proposed National Coverage Determination would cover Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED) – which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials. The proposed National Coverage Determination is open to public comment for 30 days.
COVID Updates
HHS Secretary Becerra: 12 to 15 Year-Olds Can Now Get a Pfizer Booster
Following actions by the Centers for Disease Control and Prevention and the Food and Drug Administration to expand Pfizer COVID-19 booster shots to 12 to 15 year-olds, HHS (@hhsgov) Secretary Xavier Becerra issued a statement.
FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months
The U.S. Food and Drug Administration (@US_FDA) amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine
The U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine.
Two New Over-the-Counter At-Home COVID-19 Tests Brought to U.S. Market Quickly by Biden-Harris Administration
The Biden-Harris Administration has brought two new over-the-counter, at-home COVID-19 tests to the U.S. market. The tests, one manufactured by SD Biosensor and distributed by Roche and the other manufactured by Siemens, have received emergency use authorization (EUA) by the Food and Drug Administration (FDA) after being evaluated through the Administration’s new accelerated pathway to support FDA review of tests with potential for large-scale manufacturing that the Department of Health and Human Services (HHS) announced just two months ago.
FDA Approvals in the News
LEO Pharma announces FDA approval of Adbry™ (tralokinumab-ldrm) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis
LEO Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Adbry™ (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids.1 Adbry is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.1,3,4
We approved a variety of safe and effective new drug therapies in 2021, spanning a wide range of diseases and conditions. Today, we’re releasing our New Drug Therapy Approvals report covering 2021. #FDAVoices https://t.co/WClQ2wP07V
— U.S. FDA (@US_FDA) January 14, 2022
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.
