Recon: Biogen withdraws EU application for Aduhelm; US aims to make Pfizer’s COVID pill widely available
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
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