Recon: GSK will pull blood cancer drug from US market following study setback; Teva, AbbVie finalize $6.6B US opioid settlements
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Jazz plays coda to blood cancer approval, securing FDA nod for revised dosing schedule (Fierce) ( FDA)
- Palisade Bio is Granted Fast Track Designation from the U.S. Food and Drug Administration for LB1148 for Accelerated Return of Bowel Function following GI Surgery (Biospace)
- Blenrep US Withdrawal Is A Big Blow To GSK’s Blockbuster Hopes (Scrip) (STAT) (Endpoints)
- Biden forges new $475M campaign to drive uptake of Pfizer and Moderna's bivalent Covid vaccines (Endpoints)
- Medicare Alzheimer’s Coverage Policy Advancing Clinical Trial Diversity Efforts (Pink Sheet)
- New omicron-specific boosters show modest benefit, CDC study says (Washington Post)
- The Monkeypox Cases That Might Have Been Missed (NYT)
- EMA Consults On Need For New Guide To Enable Confirmatory Platform Trials (Pink Sheet)
- Britain says monkeypox shot offers strong 78% protection (Reuters)
- Oramed inks deal to commercialize oral insulin in South Korea (Biopharma Reporter)
- Chinese exchanges say COVID testing firms to face strict IPO checks (Reuters)
- Japan to grant emergency approval to Shinogi COVID-19 drug (Reuters)
- WHO’s Draft Pandemic Treaty Calls For More Regulatory Harmonization (Pink Sheet)
- Pfizer’s $1B protein degradation bet yields 3% response rate in Arvinas’ midphase breast cancer trial (Fierce)
- Merck’s Keytruda Notches Another Win in Stomach Cancer (Biospace) (Reuters)
- Eli Lilly to double its manufacturing capacity for Mounjaro as it faces financial headwinds going into 2023 — report (Endpoints)
- Generic drugmakers Teva and Sandoz make major push to biosimilars (Reuters)
- Merck KGaA spotlights need for deals to shake up R&D, with external partners key to new drugs (Endpoints)
- Novo Nordisk invests over USD 740m in Danish facility (Medwatch) (Fierce)
- Tough Times Ahead For Towa As Japanese Generics Giant Slashes 2023 Predictions (Generics Bulletin)
- Gavi says it is not in breach of Novavax vaccine deal (Reuters)
- Erytech pivots to extracellular vesicle drug delivery after lead candidate collapses (Fierce)
- Zimmer lands 510(k) clearance for 3D-printed cementless knee replacement (MedTech Dive)
- AI Screening System For Blindness Associated With Diabetes Gets FDA Nod (MedTech Insight)
- H2o Therapeutics makes a splash with FDA nod for Parkinson’s-monitoring Apple Watch app (Fierce)
- Common Specifications: An Antidote To MDR’s Clinical Evidence ‘Moveable Feast’? (MedTech Insight)
- Medtronic cuts annual profit forecast blaming strong dollar (Reuters)
- Teleflex plans layoffs amid restructuring plan costing up to $40M (Fierce)
- AI-powered blood test detects liver cancer, opening opportunity to improve screening (MedTech Dive)
- Teva, AbbVie finalize $6.6 billion U.S. opioid settlements (Reuters)
- Delisting Of Jazz’s Xyrem Patent In Orange Book Could Spur More Infringement Counterclaims (Pink Sheet) (Endpoints)
- Anti-abortion groups file suit against FDA in Texas, demands agency revoke approval for abortion pill (Endpoints)
- J&J’s DePuy Beats Bid for Pre-Trial Ruling on Spinal-Fusion Tech (Bloomberg)
- Drug Salesman’s Convictions Vacated Over Biased Verdict Form (Bloomberg)
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