Recon: FDA authorizes Novavax vaccine; EMA re-elected ICMRA chair

| 13 July 2022 | By Michael Mezher 

Updated 13 July 2022 to note FDA's issuance of an emergency use authorization (EUA) for Novavax's adjuvanted COVID-19 vaccine.

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US

  • FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine (FDA)
  • FDA to authorize Novavax's Covid-19 vaccine (Politico)
  • Novo Nordisk's new weight loss drug Wegovy needs a 'significant discount,' ICER says (Fierce)
  • Endo Moving Toward Bankruptcy Filing Without Opioid Settlement Deal (WSJ) (Endpoints)
  • Amazon is quietly developing cancer vaccines in partnership with Fred Hutchinson and recruiting patients for a new clinical trial (Business Insider) (Endpoints)
  • U.S. accuses Fresenius Medical Care unit of fraud in dialysis treatment (Reuters)
  • Sanofi must face lawsuit over 'maximum strength' IcyHot claim (Reuters)
  • San Francisco reaches $58 mln opioid settlement with Teva, Allergan (Reuters)
In Focus: International
  • Adapted, two-strain vaccines to lift COVID protection - EU official (Reuters)
  • EMA re-elected as chair of ICMRA from October 2022 (EMA)
  • Brazil Waters Down Compulsory Licensing Law (Pink Sheet)
  • Merck wagers $290M on a cancer treatment from Finnish drugmaker (BioPharmaDive)
  • Antitrust Review of Illumina-Grail Deal Can Proceed, European Court Says (WSJ)
  • Canada's Ontario to offer second COVID booster dose to all adults (Reuters)
  • Why world's first malaria shot won't reach millions of children who need it (Reuters)
Pharma & Biotech
  • Amgen's Lumakras/immunotherapy combo data held for August lung cancer meeting (Reuters)
  • Agios CEO to step down, handing role to veteran in rare disease drug sales (BioPharmaDive)
  • Pfizer jumps into bed with Agomab, leading series B extension and lending support to Crohn’s program (Fierce)
  • With failed NIH Covid-19 study, Humanigen CEO points to competitors' flops before FDA nods (Endpoints)
  • How interest in a single cancer drug led to Ipsen's takeover of Epizyme (Endpoints)
  • TherapeuticsMD shares crater as anticipated M&A deal falls through (Endpoints)
  • EC publishes IVDR guidance in absence of completed Eudamed database (MedtechDive)
  • Eko secures heart murmur AI clearance for digital stethoscopes (Fierce)
  • Abbott gets FDA breakthrough tag for deep brain stimulation system in depression (MedtechDive)
  • Medtronic lands option to buy artery disease player CathWorks for up to $585M (MedtechDive)
  • Labcorp launches blood test for a wide range of neurodegenerative diseases and brain injuries (Fierce)
Government, Regulatory & Legal
  • Ex-Theranos CEO Holmes' Sentencing Delayed Until October (Law360)
  • Catalyst Inks Deal To End Its 'Orphan Drug' Case (Law360)
  • Mylan Can't Stop AstraZeneca's Asthma Drug Patent Suit (Law360)
  • On same day patent was granted, Alnylam claims Pfizer, Moderna infringed it in making COVID-19 vaccines (Fierce)
  • Patent Office Opposes Ruling On Ovarian Cancer Drug, Wants Stronger Obviousness Standard (Pink Sheet)
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.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you