Recon: Makers report Tamiflu shortage; Groups ask US Supreme Court to review pelvic mesh cases
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Several manufacturers report Tamiflu shortage as flu season reaches high point (Endpoints News)
- Biotech M&A, is picking back up. Here are the latest deals. (Biopharma Dive)
- FDA and EMA accept Pfizer’s regulatory submissions for ulcerative colitis drug (Endpoints News)
- WLF, AdvaMed Ask Supreme Court To Review Pelvic Mesh Litigation (MedTech Insight)
- Click wins FDA breakthrough designation for prescription digital migraine therapy (MedTech Dive)
In Focus: International
- European Regulatory Roundup, December 2022: Repositioning The MDR For A Better Year In 2023 (MedTech Insight)
- EU Guidance On Periodic Safety Update Reports: Mixed Reactions (MedTech Insight)
- UK CMA Launches Inquiry Into Steep Antibiotics Price Rise (Generics Bulletin)
- MHRA Wins £168k Funding Grant For AI Medtech Integration Project (MedTech Insight)
- Challenges Remain For Off-Patent Industry’s COVID Response (Generics Bulletin)
- UK Regulator Gets Funding For Clinical Trials With ‘Artificial Patients’ (Pink Sheet)
- Industry Breathes Sigh Of Relief Over UK Batch Release Move (Generics Bulletin)
Pharma & Biotech
- Pfizer Doubles Down on AI/ML to Bring Transformative Medicines to Patients (Biospace)
- Two Biotech CEOs Charged in Securities Fraud Schemes (Biospace)
- Trends for 2023: What's coming next in pharma marketing and drug commercialization? (Endpoints News)
- European regulators back hemophilia gene therapy (Biopharma Dive)
- Roche takes over development of Biogen-partnered lymphoma drug (Biopharma Dive)
- For ALS patients, doctors, a new medicine reignites concerns about healthcare access (Biopharma Dive)
- AbbVie: ‘We Looked At Biosimilars, We Are Not Interested’ (Generics Bulletin)
- BioNTech doses first patient in herpes vaccine candidate clinical trial (Reuters)
- BioNtech ready to ship first mRNA vaccine factory kit to Africa (Reuters)
- Vistagen buys out Pherin more than 4 years after licensing now-lead social anxiety spray (Fierce Biotech)
Medtech
- Dexcom’s Jake Leach discusses preparations for G7 launch next year (MedTech Dive)
- Philips says tests on recalled products show limited health risks (Reuters)
- Quris reels in $9M in seed funding to support AI innovations in trials (Fierce Biotech)
- 2023 forecast: A closed loop of upgraded sensors and algorithms could 'put diabetes in the background' (Fierce Biotech)
Government, Regulatory & Legal
- Interchangeable Biosimilars May Qualify For ‘Immediate Substitution’ In Medicare Part D (Generics Bulletin)
- Can a Federally Funded ‘Netflix Model’ Fix the Broken Market for Antibiotics? (New York Times)
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.
