Recon: FDA approves Sanofi’s bleeding disorder drug; Sen. Warren calls for scrutiny of Merck’s Keytruda patents

• U.S. FDA approves Sanofi’s bleeding disorder therapy (Reuters) (Endpoints)
• Moderna’s combination skin cancer therapy receives FDA’s breakthrough tag (Reuters)
• Facing Roche threat, Regeneron eyes June approval for high-dose version of Eylea (Fierce)
• Alnylam gets an adcomm for Onpattro treatment in ATTR amyloidosis (Endpoints)
• FDA to take another look at Akebia's rejected kidney drug (Endpoints)
• Pfizer says RSV shot to protect infants may be available by 2023-24 cold and flu season (Endpoints)
• US FDA Expands KASA Platform To Probe API Synthesis, Conduct NDA Quality Reviews (Pink Sheet)
• Senator Warren urges U.S. patent office to scrutinize Merck’s Keytruda (Reuters)
• Steak Dinners, Sales Reps and Risky Procedures: Inside the Big Business of Clogged Arteries (ProPublica)
• FDA, Patent Office Extend Feedback Time on Boosting Drug Access (Bloomberg)
• More Investment in Primary Care Needed, Report Finds (MedPage Today)
• More physicians are calling for fallopian tube removal to prevent ovarian cancer (STAT)
• CMS to work closely with FDA on accelerated approval payment reforms (Endpoints)
• U.S. Medicare says no change to Alzheimer’s drug restrictions (Reuters)

• New EU Body To Take The Strain As Talks On Pharma Overhaul Near (Pink Sheet)
• Novartis Seeks EU Fast Track For Iptacopan In Two Indications (Pink Sheet)
• New EU Filings (Pink Sheet)
• Most parts of the world saw maternal mortality rates spike in 2020 (Reuters) (STAT)
• For the World Bank, Public Health Is the Priority: Tyler Cowen (Bloomberg)
• South Africa reports first death due to cholera as cases rise to five (Reuters)

• Generic drugmaker Akorn shutters Illinois plant, lays off 400 employees (Endpoints) (Fierce)
• Jounce pounces on exit opportunity, laying off 57% of staff alongside reverse merger with Redx (Fierce) (BioSpace) Reuters)
• Layoffs not letting up: Impel, Cybin, EQRx all trim head counts with eyes on saving cash (Fierce) (Endpoints)
• In reorganization, Bayer lays off 55 at Berkeley, California, campus (Fierce)
• Moderna enters R&D collaboration for mRNA gene-editing therapies (Reuters)
• Capsida and AbbVie make $70M upfront deal for genetic medicines in eye diseases (Endpoints)
• Astra Clinches Deal for China Drug to Boost Cancer Pipeline (Bloomberg)
• As Novartis pulls back from legacy sickle cell program, Intellia CEO calls the market ‘wide open’ (Fierce)
• Astellas Presents Update on Recently Cleared Pompe Gene Therapy Trials (BioSpace) (Endpoints)
• BioNTech touts differences with Moderna in race for cancer vaccines (Endpoints)
• Graphite Bio gives up on lead sickle cell program, halves staff in wake of safety scare (Endpoints)

• Hyperfine scores EU approval of portable MRI system, setting up possible global expansion (Fierce)
• Deals Shaping The Medtech And Diagnostics Industry, January 2023 (MedTech Insight)
• German Reform: ‘Sense Of Proportion’ Urged By Hospitals (MedTech Insight)
• The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight (STAT)
• Medtronic’s H1 freefall slows to a stop with flat revenues in Q3, lifting its final forecast (Fierce)
• Dentsply Sirona to lay off up to 10% of workforce, restructure operating model (Fierce)

• J&J Rebuffed by US Supreme Court on Vaginal-Mesh Award (Bloomberg)
• AliveCor says enforcement of Apple Watch import ban may take more than a year (MedTech Dive) (Fierce)
• Gilead, Teva and J&J’s HIV antitrust case inches closer to trial as judge keeps most claims on the table (Fierce)
• J&J to impose new limits on 340B access after industry court win (Endpoints)
• Charles River handed subpoena by DOJ over non-human primate supply (Endpoints)