Recon: FDA adcomm gives thumbs up to GSK’s anemia drug; Italy alleges Pfizer hid $1.2B in profits

ReconRecon | 27 October 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • A Mixed AdComm: REMS Seems Possible For GSK’s Anemia Drug, Dual Indication Likely Needs More Data (Pink Sheet) (Biospace) (Reuters) (Fierce)
  • FDA sets Seres on the priority review path for its microbiome C. difficile drug, setting up April decision (Endpoints) (Fierce)
  • FDA approves J&J's BCMA-targeted bispecific for multiple myeloma (Endpoints)
  • Failed Confirmatory Trial Won’t Force Withdrawal Of Zepzelca’s Accelerated Approval, US FDA Says (Pink Sheet) (Fierce) (Endpoints)
  • US Delays Review of First Nonprescription Birth-Control Pill (Bloomberg)
  • DiaMedica Ischemic Stroke Program Remains on Hold with Plans for Additional Studies  (Biospace) (Fierce)
  • Moderna Nears US Deal to Develop Shots for Ebola, Other Threats (Bloomberg)
  • Emergency clinical research: Biden's OSTP wants to settle 'key terms' in advance of trials (Endpoints)
  • Updated: Contamination issues lead to FDA warning letter for South Carolina manufacturing facility (Endpoints) (Fierce)
  • Indian site for Jubilant Generics lands Form 483 for QC issues (Endpoints)
  • Aurobindo Pharma’s US branch issues a recall of two generic medicines (Endpoints)
  • Mylan Recalls Lot of Octreotide Acetate Injection, 500 mcg/mL (Bloomberg)
  • McKinsey reaches deal with US local governments over opioids (Reuters)
In Focus: International
  • Pfizer Hid $1.2 Billion Profit, Italian Investigators Allege (Bloomberg) (Reuters) (STAT)
  • Energy crisis risks upending Europe's key medicine supply chains - industry says (Reuters)
  • EU-Wide Compulsory Licensing Proposal: A Welcome Development Or A Threat To Patent Exclusivity? (Pink Sheet)
  • Global COVID cases will increase in coming months, but at a slower pace, analysis says (Reuters)
  • Tuberculosis deaths rose during pandemic, reversing years of decline – WHO (Reuters)
  • Africa CDC: Ebola outbreak in Uganda "not getting out of hand" (Reuters)
  • MSD Fined €39m In Spain Over Blocking Nuvaring Rival (Pink Sheet)
  • Australia pathology data stolen as hacking epidemic widens (Reuters)
Pharma & Biotech
  • GSK dumps major pipeline prospect otilimab on lackluster phase 3 data in rheumatoid arthritis (Fierce) (Reuters) (Biospace)
  • Bristol Myers keeps Obsidian cell therapy pact rocking with multiyear extension (Fierce)
  • Vaxcyte's data lead to $600M haul, while Taysha looks to raise cash after Astellas deal (Endpoints)
  • AstraZeneca spotlights positive PhIII readout for a pair of next-gen breast cancer drugs (Endpoints)
  • Roche’s Vabysmo lands clinical counterpunch in ophthalmology brawl with Eylea (Fierce)
  • Merck & Co. ditches oncolytic virus Cavatak 4 years after buying Viralytics (Fierce)
  • UPDATED: Biogen insists Eisai relationship ‘solid’ as questions remain over lecanemab commercialization (Fierce)
  • What is Novartis without Sandoz? Vas Narasimhan is 'patient' as new company takes form (Endpoints)
  • Merck's CEO to succeed Ken Frazier as chairman (Reuters)
  • A new suite of RNA-sensing tools could help scientists target cancerous cells, and much more (STAT)
Medtech
  • TEAM-NB Position Paper Helps Manufacturers Manage And Benefit From Off-Label Use (MedTech Insight)
  • FDA expands label of 23andMe genetic report predicting response to popular cholesterol drug (Fierce)
  • Switzerland Moves Closer To Accepting US FDA-Approved Medtech (MedTech Insight)
  • Medtronic Launches Platform To Gather Ideas To Improve Stroke Treatment (MedTech Insight)
  • Baxter Issues Alert On Incontinence Management System (MedTech Insight)
  • Medtech M&A decline poised to continue in 2023 amid ‘bumpy’ market: report (MedTech Dive)
  • Boston Scientific exceeds Q3 revenue growth forecast on heart devices; profit sinks on R&D costs (MedTech Dive) (Fierce)
  • Baxter lowers 2022 earnings forecast, citing supply chain, foreign-exchange pressures (MedTech Dive)
Government, Regulatory & Legal
  • New England Opioid Force Makes First Unlawful Prescribing Arrest (Bloomberg)
  • Eagle Loses Patent Ruling on Branded Rivals of Belrapzo Drug (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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