Recon: FDA approves Sanofi’s bleeding disorder drug; Sen. Warren calls for scrutiny of Merck’s Keytruda patents
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
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