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

ReconRecon | 23 February 2023 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory and Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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