Recon: Patients, providers left with questions on FDA’s breakthrough devices; BMS, Nektar end $3.6B deal after latest late-stage misses
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- As FDA offers breakthrough designation to device makers, patients and providers are left with questions (STAT) (Tracker)
- When OS is the 'ultimate safety endpoint': FDA leaders question single-arm trials amid scrutiny of PI3K drugs for blood cancer (Endpoints)
- TG Therapeutics withdraws U2 application — and its component's approvals — one week before adcomm (Endpoints)
- Pitching Drugs To Physicians: Disclosing Limitations Of Clinical Data May Be Beneficial (The Pink Sheet)
- US FDA Suggests ‘Enhancements’ To Opioid Blueprint; CE Providers Want ‘Flexibility’ (The Pink Sheet)
- Return Of Ductwork Cross-Contamination In Plants Flagged By US FDA Experts (The Pink Sheet)
- War in Ukraine may require significant trial changes, EMA says in new guidance (Endpoints) (EMA)
- White House Global Covid-19 Summit to be held in May (Politico) (Reuters)
- India Is Stalling the W.H.O.’s Efforts to Make Global Covid Death Toll Public (NYT)
- Japan health ministry panel approves Novavax's COVID-19 vaccine (Reuters)
- Omicron-specific Sinopharm, Sinovac COVID vaccine candidates cleared for clinical trial (Reuters)
- Taiwan says COVID vaccine talks held up on China sales deal (Reuters)
- The case for testing Pfizer's Paxlovid for treating long COVID (Reuters)
- Men and women may respond differently to vaccines. Research needs to account for that (STAT)
- Plea To FDA From Those Injured By COVID-19 Vaccines: ‘Please Hear Us’ (The Pink Sheet)
- Hit by 2 more flops, Bristol Myers and Nektar wind down IL-2/PD-1 program at the center of $3.6B deal (Endpoints) (Scrip) (BioSpace)
- With more than 30 oncology partners, Gilead lays out its 2030 vision of 20 new approvals (Endpoints)
- Tech Transfer Roundup: Lysogene Elects Option On Gene Therapy Discovered At Weizmann Institute (Scrip)
- Imara reduced to six employees as the biotech, once again preclinical, explores its options (Endpoints)
- A potential target for Alzheimer's treatment? Researchers unearth new immune response pathway (Endpoints)
- Synthetic blood substitute research advances rapidly (Washington Post)
- More than 50 percent of people worldwide have headache disorders (Washington Post)
- Device Makers Are Bucking Decades-Long Trend Of Launching Products In EU. Here’s Why (MedTech Insight)
- COVID-19 testing landscape changes as omicron subvariant spreads (MedTech Dive)
- Natus Medical to go private in $1.2B private equity acquisition deal (Fierce)
- A medtech company's SPAC merger falls flat, missing on nine-figure valuation (Endpoints)
- Bristol Myers Squibb inks $11M deal to settle anticompetitive claims in HIV suit (Endpoints)
- Roche Ruling Highlights High Bar For Induced Infringement (Law360)
- Amgen Cholesterol Patent Fight Needs DOJ’s Take, Justices Say (Bloomberg)
- Opioid Trial Gamble Pays Off For W.Va. In $99M Deal With J&J (Law360) (Reuters)
- Bard Hit With $255,000 Verdict in Second Hernia Mesh Test Trial (Bloomberg)
- Jury Told Balwani Provided Theranos’ Investor Financial Data (Law360)
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