Recon: GSK will pull blood cancer drug from US market following study setback; Teva, AbbVie finalize $6.6B US opioid settlements

ReconRecon | 22 November 2022 |  By 

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)
In Focus: International
  • 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
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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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