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Recon: FDA adcomm offers thumbs as much as GSK’s anemia drug; Italy alleges Pfizer hid $1.2B in earnings

Recon | 27 October 2022 | By

Welcome to Regulatory Reconnaissance, your each day regulatory information and intelligence briefing.

In Focus: US

  • A Blended AdComm: REMS Appears Potential For GSK’s Anemia Drug, Twin Indication Seemingly Wants Extra Information (Pink Sheet) (Biospace) (Reuters) (Fierce)
  • FDA units Seres on the precedence evaluation path for its microbiome C. difficile drug, establishing April determination (Endpoints) (Fierce)
  • FDA approves J&J’s BCMA-targeted bispecific for a number of myeloma (Endpoints)
  • Failed Confirmatory Trial Will not Pressure Withdrawal Of Zepzelca’s Accelerated Approval, US FDA Says (Pink Sheet) (Fierce) (Endpoints)
  • US Delays Evaluate of First Nonprescription Beginning-Management Capsule (Bloomberg)
  • DiaMedica Ischemic Stroke Program Stays on Maintain with Plans for Further Research (Biospace) (Fierce)
  • Trendy Nears US Deal to Develop Photographs for Ebola, Different Threats (Bloomberg)
  • Emergency medical analysis: Biden’s OSTP desires to settle ‘key phrases’ upfront of trials (Endpoints)
  • Up to date: Contamination points result in FDA warning letter for South Carolina manufacturing facility (Endpoints) (Fierce)
  • Indian web site for Jubilant Generics lands Type 483 for QC points (Endpoints)
  • Aurobindo Pharma’s US department points a recall of two generic medicines (Endpoints)
  • Mylan Recollects Lot of Octreotide Acetate Injection, 500 mcg/mL (Bloomberg)
  • McKinsey reaches take care of US native governments over opioids (Reuters)

In Focus: Worldwide

  • Pfizer Hid $1.2 Billion Revenue, Italian Investigators Allege (Bloomberg) (Reuters) (STAT)
  • Vitality disaster dangers upending Europe’s key medication provide chains – trade says (Reuters)
  • EU-Extensive Obligatory Licensing Proposal: A Welcome Growth Or A Risk To Patent Exclusivity? (Pink Sheet)
  • World COVID circumstances will enhance in coming months, however at a slower tempo, evaluation says (Reuters)
  • Tuberculosis deaths rose throughout pandemic, reversing years of decline – WHO (Reuters)
  • Africa CDC: Ebola outbreak in Uganda “not getting out of hand” (Reuters)
  • MSD Funded €39m In Spain Over Blocking Nuvaring Rival (Pink Sheet)
  • Australia pathology information stolen as hacking epidemic widens (Reuters)

Pharma & Biotech

  • GSK dumps main pipeline prospect otilimab on lackluster section 3 information in rheumatoid arthritis (Fierce) (Reuters) (Biospace)
  • Bristol Myers retains Obsidian cell remedy pact rocking with multiyear extension (Fierce)
  • Vaxcyte’s information result in $600M haul, whereas Taysha appears to be like to lift money after Astellas deal (Endpoints)
  • AstraZeneca spots constructive PhIII readout for a pair of next-gen breast most cancers medication (Endpoints)
  • Roche’s Vabysmo lands medical counterpunch in ophthalmology brawl with Eylea (Fierce)
  • Merck & Co. ditches oncolytic virus Cavatak 4 years after shopping for Viralytics (Fierce)
  • UPDATED: Biogen insists Eisai relationship ‘stable’ as questions stay over lecanemab commercialization (Fierce)
  • What’s Novartis with out Sandoz? Vas Narasimhan is ‘affected person’ as new firm takes type (Endpoints)
  • Merck’s CEO to succeed Ken Frazier as chairman (Reuters)
  • A brand new suite of RNA-sensing instruments might assist scientists goal cancerous cells, and way more (STAT)

medtech

  • TEAM-NB Place Paper Helps Producers Handle And Profit From Off-Label Use (MedTech Perception)
  • FDA expands label of 23andMe genetic report predicting response to common ldl cholesterol drug (Fierce)
  • Switzerland Strikes Nearer To Accepting US FDA-Authorised Medtech (MedTech Perception)
  • Medtronic Launches Platform To Collect Concepts To Enhance Stroke Therapy (MedTech Perception)
  • Baxter Points Alert On Incontinence Administration System (MedTech Perception)
  • Medtech M&A decline poised to proceed in 2023 amid ‘bumpy’ market: report (MedTech Dive)
  • Boston Scientific exceeds Q3 income development forecast on coronary heart gadgets; revenue sinks on R&D prices (MedTech Dive) (Fierce)
  • Baxter lowers 2022 earnings forecast, citing provide chain, foreign-exchange pressures (MedTech Dive)

Authorities, Regulatory & Authorized

  • New England Opioid Pressure Makes First Illegal Prescribing Arrest (Bloomberg)
  • Eagle Loses Patent Ruling on Branded Rivals of Belrapzo Drug (Bloomberg)

Regulatory Recon is our each day intelligence briefing for the regulatory affairs area, bringing you the highest regulatory, biopharma and medtech information tales from across the globe.

A narrative’s inclusion in Regulatory Recon doesn’t indicate endorsement by Regulatory Focus or RAPS.

© 2022 Regulatory Affairs Professionals Society.


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