Recon: Patients, providers left with questions on FDA’s breakthrough devices; BMS, Nektar end $3.6B deal after latest late-stage misses

• 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)