Recon: FDA posts FY 2023 user fees; FDA grants fast-track designation to Lilly’s obesity drug Mounjaro

ReconRecon | 06 October 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Eli Lilly gets FDA's speedy review for obesity drug (Reuters) (Biospace)
  • US FDA's FY 2023 User Fees Finally Revealed (Pink Sheet)
  • FDA rejects Eiger's emergency use request for repurposed Covid-19 treatment (Endpoints)
  • Pepaxto Adcom Saw Public Airing Of Unusual Level Of Discord Between US FDA, Oncopeptides (Pink Sheet)
  • Two CRLs later, Illinois-based CDMO hit with FDA warning letter over 'spore-forming' bacteria and fungi (Endpoints)
  • New Name, Old Problems: US FDA’s Cell And Gene Therapy Office Still Facing Growth Challenges (Pink Sheet)
  • Kite Pharma gets FDA to sign off on new California-based vector manufacturing facility (Endpoints)
  • Nearing a ‘watershed’ year, biosimilar industry gets a boost from Inflation Reduction Act (Fierce)
  • After coverage restrictions for Alzheimer's drugs, bipartisan House bill would force CMS to review drugs individually (Endpoints)
  • Dutch CDMO Intravacc gets NIH grant of up to $14.6M to make gonorrhea vaccine (Endpoints)
  • Lag in Biden’s NIH Nominee Creates Tougher Confirmation Scenario (Bloomberg)
  • Exclusive: Biden to nominate U.S. surgeon general to join WHO executive board, official says (Reuters)
In Focus: International
  • Codeine/Ibuprofen Combo Safety Concerns Prompt EMA Call For Prescription-Only Status (Pink Sheet)
  • Pfizer COVID vaccine clears Japan panel for use with young children (Reuters)
  • Canada Addresses Diversity in Clinical Trials With New Rule For Drug Filings (Pink Sheet)
  • WHO Medicines Access Platform ‘Compromised’ By Industry Involvement (Pink Sheet)
  • Reimbursement, Vaccine Issues Dominate EU Group's Korea Concerns (Pink Sheet)
  • India tests samples of cough syrup linked to deaths of children in Gambia (Reuters)
  • ‘Patchy efforts’ by major insulin makers mean access lags in many poor countries (STAT)
  • New Ebola Vaccines Being Prepared for Trials in Uganda, WHO Says (Bloomberg)
Pharma & Biotech
  • GSK touts topline win for PD-1 in head-to-head with Keytruda — while steering next big checkpoint drug into PhIII (Endpoints)
  • Lilly inks $425M biobuck drug discovery pact with Schrodinger (Fierce)
  • TauRx’s Alzheimer’s trial failed to deliver the pre-specified analysis. It plans to seek approval anyway (Fierce)
  • Fresenius taps pre-dialysis kidney care as drugs promise treatment change (Reuters)
  • J&J, Legent double CAR-T manufacturing investment to $500M as Carvykti eyes wider myeloma use (Fierce)
  • Nested Therapeutics Raises $90M to Crack New Proteins in Precision Oncology (Biospace)
  • Merck KGaA Overcomes Ukraine Disruption To Keep MS Frontrunner On Track (Scrip)
  • Lecanemab trial ‘pivotal’ for other therapy developers targeting Alzheimer’s disease (BioPharma Reporter)
  • Sanofi inks deal with TrialSpark to find, license new drugs (Fierce)
  • Anticipating FDA Yes, Provention Inks Co-Promotion Deal with Sanofi for T1D Drug (Biospace)
  • Merck's $500M bet on Singapore leads to new manufacturing sites making Keytruda, Gardasil and future inhalers (Endpoints)
  • Tour de biotech: Cyclerion peddles through another disease area, laying off 45% amid heel turn toward mitochondria (Fierce)
  • Amgen unveils its second-largest R&D site, opening 245,000-square-foor facility in San Francisco  (Fierce)
  • CNS-focused gene therapy biotech forges manufacturing deal for hearing loss drug (Endpoints)
  • Three scientists win chemistry Nobel Prize for developing ‘click’ and ‘bioorthogonal’ chemistry (STAT)
  • Roche nets FDA approval for HER2-low breast cancer test paired with AstraZeneca-Daiichi’s Enhertu (Fierce) (MedTech Dive)
  • Medical Device Makers Get Tips on Safety Monitoring After Sales (Bloomberg)
  • EU Proposal To Have Guidance Transition Periods “Does Not Make Sense” (MedTech Insight)
  • UK’s NICE Goes Ahead With Parkinson’s Product Funding But Pending Real-World Data (Medtech Insight)
  • Expert Panel View On First Ebola Test Submission: Reservations About Use in EU (MedTech Insight)
  • Medtech companies shift strategy as more orthopedic procedures move to ambulatory surgical centers (MedTech Dive)
  • AstraZeneca takes home two more computer-generated drug targets from Benevolent AI (Fierce)
Government, Regulatory & Legal
  • Eli Lilly and Teva prepare for court battle over migraine med rivalry (Endpoints)
  • U.S. judge temporarily blocks two state lawsuits over J&J talc marketing (Reuters)
  • In Daiichi case, court upholds jury’s $177.8M infringement ruling against Novartis (Fierce)
  • Generic Drugmaker Asks Justices to Lift Pause on Gilenya Ruling (Bloomberg)
  • In Since-Sealed Order, Clues on Timing of Teva’s Cabometyx Copy (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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