Recon: Biogen withdraws EU application for Aduhelm; US aims to make Pfizer’s COVID pill widely available

• Axsome expects US FDA to decline approval for migraine drug, shares fall (Reuters)
• After 18 years in development, AstraZeneca’s CTLA-4 antibody gets the red carpet treatment at the FDA (Endpoints)
• FDA warns small biotech Ocugen of potential $10K fines for failing to post trial results (Endpoints)
• FDA plots multi-day hearing to review 'dangling' accelerated approval that drugmaker refuses to pull (Endpoints)
• New paper sheds fresh light on Tmunity's high-profile CAR-T deaths (Endpoints)
• Pfizer Covid Pill Nears Wider Availability Under Biden Plan (Bloomberg)
• FTC’s Take On Two Pharma Mergers Shows Deals Can Clear Higher Hurdle (The Pink Sheet)
• A new nonprofit wants to rewrite the playbook for how the US government funds science (STAT)
• Pharma shells out more than $300K to brother of top Biden aide in 3 months (Endpoints)

• Biogen Pulls EU Filing For Aduhelm But Stands By Alzheimer’s Drug (The Pink Sheet) (Endpoints) (Reuters)
• WHO says 12 countries have reported unusual cases of hepatitis in kids (STAT) (Reuters) (Bloomberg)
• EU regulator backs using Pfizer COVID shot as booster after other vaccines (Reuters)
• WHO Backs Pfizer’s Paxlovid For High-Risk COVID-19 Patients (The Pink Sheet) (WHO)
• New Ebola case confirmed in northwestern Congo, health authorities say (Reuters) (Bloomberg)
• Roche warns multiple sclerosis drug development hit by Ukraine war (Reuters)
• Amryt Earns Wings For Butterfly Skin Drug In Europe (Scrip)
• What Vexed Top Global Biopharmaceutical Executives About COVID-19 Response (The Pink Sheet)
• UK's Cambridge Keen To Challenge US Counterpart With Biotech Start-Ups (Scrip)
• 25% cut in India’s API import reliance by 2024, says health minister (Economic Times)

• Roche sees slowdown in COVID-driven sales growth (Reuters)
• Japan's Shionogi says COVID-19 pill shows rapid clearance of virus (Reuters)
• Nasal Sprays Are Poised to Be the Next Weapon for Fighting Covid (Bloomberg)
• The Drive to Vaccinate the World Against Covid Is Losing Steam (New York Times)
• Scientists Urge FDA To Assess T-Cell Levels In COVID-19 Vaccine Analysis (Inside Health Policy)
• Despite losing federal money, California is still testing uninsured residents for COVID-for now (Fierce)

• Valneva slumps after EU regulator requests more COVID vaccine data (Reuters)

• Roche hit with another key R&D setback as oral SERD flops in breast cancer (Endpoints)
• Nkarta studies of engineered natural killer cells show complete remissions in patients with blood cancers (STAT)
• Reprogramming a new type of T cell to go after cancers with less side effects, longer impact (Fierce)
• Phase 2 déjà vu for gossamer bio after ulcerative colitis med flops (Fierce)
• Pfizer recalls some batches of blood pressure drug over carcinogen presence (Reuters)

• Changes Featured In Upgraded Eudamed Economic Operator User Guide (MedTech Insight)
• 11 Plead Guilty For Roles In $300M Diagnostic Fraud (MedTech Insight)
• Labcorp beefs up at-home testing options with Getlabs’ on-demand blood draw service (Fierce)
• PreciseDx Shows Nerves Under Tongue May Provide Key Information On Parkinson’s (MedTech Insight)

• Anthem Prosthetic Device Settlement Wins ‘Conditional’ Approval (Bloomberg)
• Ranbaxy Buyers Seek OK On $485M Deal In Generics MDL (Law360)
• Balwani Never Told Theranos Lab Director To Lie, Jury Hears (Law360)
• Walgreens, Teva face San Francisco trial over opioid epidemic (Reuters)
• Bluebird Bio Beats Investors’ Sickle Cell Therapy Timeline Suit (Bloomberg)