Recon: FDA adcomm gives Alnylam’s Onpattro thumbs up for heart indication; White House negotiates price caps in deal with Regeneron for COVID-19 antibody

• FDA panel endorses Alnylam’s heart drug — after picking apart its supporting data (STAT) (Endpoints)
• Lawmakers introduce bill to require drugmakers to provide key info to both FDA and U.S. Patent Office (STAT)
• In new Regeneron deal for Covid drug, White House imposes price limits for first time (STAT)
• Warren, Jayapal Urge FTC to Fight ‘Sham’ Drug Patent Tactics (Bloomberg Law)
• CDER challenges Oncopeptides’ appeal over Pepaxto withdrawal (Endpoints)
• FDA makes some strides in easing US cancer drug supply shortages by working with manufacturers (Endpoints)
• US pharmacy chains gear up to administer updated COVID shots (Reuters)
• Biden administration pushes back on Merck’s drug price negotiation challenge (The Hill)
• FDA finalizes combination product guidance 7 years after sharing draft (MedTech Dive)

• EU regulator panel recommends authorizing Moderna's updated COVID shot (Reuters)
• UK to invest extra 200 million pounds in National Health Service over winter (Reuters)
• Astellas earmarks $354.2M for Irish build; Samsung Biologics get into ADCs; Rentschler gets UK facility approved (Endpoints)
• Goa state warns Abbott India on antacid Digene licence suspension (Reuters)
• India's Nipah virus trackers gather samples from bats, fruit (Reuters)
• Cough syrup killed scores of children. Why no one has been held to account (Reuters)
• Bristol Myers plans to double experimental treatments to expand research pipeline (Reuters)

• Civica Rx considers moving into chemo drugs as shortages worsen (STAT)
• Moderna cuts four programs in vaccines, solid tumors and heart failure as it increases, prioritizes pipeline (Endpoints)
• Moderna flu shot succeeds in late-stage study (Reuters)
• Acelyrin, a rare IPO success, stumbles in its first big test (STAT)
• Akili abandons prescription business model, to lay off 40% of workers (STAT)
• The ‘Hispanic Paradox’ intrigues a new generation of researchers determined to unravel it (STAT)
• AbbVie turns its back on Harpoon’s BCMA-targeting multiple myeloma drug (Endpoints)
• Q&A: Lonza CGT president Daniel Palmacci talks manufacturing amid lower sales outlook (Endpoints)
• Gene therapy biotech AlveoGene launches with lentiviral platform for respiratory diseases (Endpoints)

• Class I Recall For Abbott Implantable Pulse Generators (MedTech Insight)
• Machine learning biotech raises $273 million in rare successful late-stage round (STAT)
• Novelist John Green launches attack on Cepheid over the price of its TB test (STAT)
• Flagship’s AI unicorn Generate raises $273M Series C, as first drug in 17-program pipeline enters the clinic (Endpoints)
• Orthofix fires CEO, CFO after investigation finds misconduct (MedTech Dive)
• Minute Insight: Mainz Biomed Shows Off New Colorectal Cancer Diagnostic Test Data (MedTech Insight)
• As Digital Health Races Forward, Governments’ Understanding Of It May Be Stalling (MedTech Insight)

• What to make of Biden’s latest Cancer Moonshot efforts (STAT)
• Proposed $35 price cap on insulin heads to Gov. Gavin Newsom's desk (CBS)
• TB deaths prompt FDA warning on reducing transmission risk (MedTech Dive)
• GAO Report Highlights Concerns About Device Advertising (MedTech Insight)