Pharma Update January 2022

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.

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.

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.

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.

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

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.

• Approvals of FDA-Regulated Products
• Consumer Updates
• COVID-19
• Drug Supply Chain Security Act (DSCSA)