Recon: Sanofi, GSK to seek approval for COVID vaccine candidate; Novavax begins shipping vaccines to EU states
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Sanofi, GSK to seek authorization for COVID-19 vaccine following ‘strong’ results (The Hill) (Reuters) (Fierce)
- FDA limits use of GlaxoSmithKline-Vir COVID-19 drug (Reuters)
- Lawmakers Eye Linking Lab Test Oversight Bill to FDA Fee Plan (Bloomberg) (STAT)
- Remote Inspections: Stakeholders Seek Clarity As Some At US FDA Struggle With Process (The Pink Sheet)
- US FDA Lowers Bar for Latest COVID Monoclonal Antibody Authorization (The Pink Sheet)
- Is the Senate gearing up to actually pass drug pricing legislation? (STAT)
- Mallinckrodt chalks up CRL to packaging and labeling facility struggles (Endpoints)
- Almost 9 in 10 Americans want the FDA to explain why some drugs are rejected, new JAMA survey finds (Endpoints) (JAMA)
- Moderna Inks Latin America Deal in Bid to Expand its Reach (Bloomberg)
- As Biotech Cash Dries Up, Ireland's Priothera Gets EU Backing For Leukemia Drug (Scrip)
- Chinese cell therapy company opens first US manufacturing site (Endpoints)
- WHO announces 2nd hub for training countries to make COVID vaccines (Reuters) (Endpoints)
- Africa CDC to ask world to pause Covid-19 vaccine donations (Politico)
- Novavax starts shipping COVID vaccine to EU states (Reuters)
- COVID-19 shot interval can be extended to 8 weeks for some -U.S. CDC (Reuters)
- Deutsche Telekom to build global COVID vaccine verification app for WHO (Reuters)
- EU countries agree to admit travellers vaccinated with WHO-approved shots (Reuters)
- Patient advocates sue South African government over access to Covid-19 vaccine contracts (STAT)
- Antibody triggered by Sinopharm COVID booster wanes after six months – study (Reuters)
- Stability woes torpedo Marinus’ phase 3 seizure timeline, combining with COVID-19 to cause one-year delay (Fierce)
- Coronavirus vaccine protection was much weaker against omicron, data shows (Washington Post)
- Plexium nabs $102M for protein degradation work weeks after $500M Amgen tie-up (Fierce)
- Roche’s gene therapy unit finds a new Spark as co-founding CEO makes way for new leader (Fierce)
- Poseida taps former Novartis VP as president of gene therapy (Fierce)
- Mnemo lures Bayer oncology business chef as new CEO to lead CAR-T work (Fierce)
- Not All mABs For Alzheimer’s Are Created Equal, Manufacturers Tell Medicare (The Pink Sheet)
- Kodiak’s Eylea rival hits ‘major disappointment’ with failure in first of 6 phase 3 studies (Fierce)
- Kiniksa inks licensing deal to take a Regeneron castoff into Asian markets (Endpoints)
- They made the first anti-VEGF drug 20+ years ago. Now two longtime partners have $65M to spot new eye drugs (Endpoints)
- SoftBank, RA keep pumping money into biotech startups as protein degradation player bags $102M (Endpoints)
- Diabetes tech leaders expect another year of growth, innovation as competition soars (MedTech Dive)
- What does a more aggressive M&A approach mean for J&J's devices unit? (MedTech Dive)
- FDA broadens approval for Abbott’s sensor implant to catch early cases of heart failure (Fierce)
- Medtronic's Q3 revenue misses estimates as omicron curbs procedures (MedTech Dive)
- Malaysia Consults On Medical Device Risk Classifications (MedTech Insight)
- China’s Medtech Market Trends: Six Of The Best For 2022 (MedTech Insight)
- Smith & Nephew taps Siemens diagnostics head to replace outgoing CEO (Fierce)
- Cardiovascular Systems plots moves into blood clot removal with development deal (Fierce)
- Mallinckrodt Wins Approval Of $66M Securities Deal (Law360)
- Democrats urge HHS to 'march-in' or enable 'government-use' rights to make Xtandi less expensive (Endpoints)
- Three Sentenced in $100M Medicare Call Center Fraud Scheme (MedTech Insight)
- Pharmacy Liaison Probe Must Be More ‘Rigorous’ to Get FTC Vote (Bloomberg)
- Blatant abuse of Chapter 11? J&J says its use of 'Texas two-step' is all about fairness (Endpoints)
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