Recon: WHO investigating cough syrup deaths; EU patient groups push for greater measures to address antibiotic shortages

ReconRecon | 24 January 2023 |  By 

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

In Focus: US
  • Many pediatric drug study results were never posted to a U.S. government database (STAT)
  • COVID Vaccines: What FDA Isn’t Talking About Ahead Of Upcoming Advisory Panel (Pink Sheet)
  • US FDA Wants Global COVID-19 Vaccine Update System, But Says May Not Be Possible (Pink Sheet)
  • Advisory Committee Disagreement With US FDA On Approval Decisions An Increasingly Rare Event (Pink Sheet)
  • Payers, Medical Journals Could Help Push For Clinical Trial Diversity, Cavazzoni Says (Pink Sheet)
  • Advocacy group accuses Novo Nordisk of violating FDA's 'fair balance' advertising rules (Endpoints)
  • FDA Made the right Call on Lilly’s Donanemab, Some Experts Say (Biospace)
  • ODAC Confidential: The seven deadly sins sponsors commit again and again at FDA presentations (Cancer Letter)
  • Baby Food Makers Get FDA’s Proposed Lead Limits After Delay (Bloomberg)
In Focus: International
  • WHO investigating links between cough syrup deaths, considers advice for parents (Reuters)
  • As antibiotics run scarce, Europe outlines drug shortage countermeasures (Fierce)
  • EU must do more to tackle antibiotic shortages, say patient groups (Reuters)
  • J&J expects inflation, China COVID hit to carry into 2023 (Reuters)
  • Russia's Putin says stockpile needed to curb drug shortages (Reuters)
  • Ibrance Generics Arrive In India, Patient Programs Add Free Drug Component (Scrip)
  • Notified Bodies Follow Expert Panel Opinions Under EU MDR To The Letter (MedTech Insight)
Pharma & Biotech
  • Finch throws in the towel on microbiome journey, lets go of 77 employees (Endpoints)
  • Frosty funding forecast forces Finch to stop phase 3 trial, lay off 95% of staff and seek buyers for assets (Fierce)
  • Bayer’s oncology business looks to collect $10B in sales by 2030, exec says (Fierce)
  • #JPM23: Fireside chat with Eisai's Ivan Cheung (Endpoints)
  • After Lilly complaint, Novartis pulls claim in DTC cancer drug ad (Endpoints)
  • Eli Lilly to invest $450 mln more to expand diabetes drug plant capacity (Reuters) (Fierce)
  • Neurofilament Biomarker to Face Key Test at Biogen-Ionis’ Tofersen Adcom (Biospace)
  • The rise of venture debt and when biotechs should- and shouldn’t- use it (Fierce)
  • Calico looking for new chief scientist after celebrated biologist David Botstein quietly retires (STAT)
  • PhRMA terminates lobbying contract with White House official’s brother (STAT)
  • Roivant’s Matt Gline on the hub-and-spoke biotech model and lessons learned from Axovant (Biopharma Dive)
Medtech
  • Insulet reports personal-data leak of 29,000 insulin pump customers (MedTech Dive)
  • Belgian Research Reveals Extent Of EU’s Digital Health Tech Reimbursement Labyrinth (MedTech Insight)
  • Asensus expands its surgical AI vision with European approval (Fierce)
Government, Regulatory & Legal
  • J&J Subsidiary Pays $9.75M To Resolve Kickback Allegations (MedTech Insight) (US News)
  • Law firms target Spectrum over lung cancer trial statements (Fierce)
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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