Recon: AstraZeneca seeks EUA for preventative COVID antibody; EMA considers rolling review for Merck's COVID drug

| 05 October 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer/BioNTech COVID-19 vaccine effectiveness drops after 6 months, study shows (Reuters)
  • J&J files for authorization of COVID-19 vaccine booster (Reuters)
  • AstraZeneca Submits Preventive Covid-19 Treatment for FDA Authorization (WSJ) (Reuters)
  • Pharmacy chains failed to prevent opioid misuse, U.S. jury hears (Reuters)
  • Henrietta Lacks' estate says pharma company profited from stolen cells (Reuters)
  • Eli Lilly’s recalled emergency diabetes drug came from plant cited by FDA (Reuters)
  • Rapid COVID-19 tests increasingly scarce, pricey as demand from employers jumps (Reuters)
  • Feds accuse AstraZeneca of underpaying 318 female and Hispanic employees (Endpoints)
  • NIH Director Francis Collins to step down (STAT)
In Focus: International
  • EMA to consider rolling review for Merck's molnupiravir in coming days (Reuters)
  • Europe’s drug regulator said a booster shot of the Pfizer-BioNTech vaccine could be given to healthy adults. (NYTimes)
  • NICE recommends first new sickle cell disease treatment in 20 years (Pharmafile)
  • Norway to offer COVID vaccine booster to those aged 65 and older (Reuters)
Pharma & Biotech
  • GlaxoSmithKline abandoning iconic US HQ space in a shift inspired by the new normal (Endpoints)
  • Innovative Licensing and Access Pathway (ILAP): New partner announcement (MHRA)
  • Aduhelm In Medicaid: States Must Cover, CMS Official Says (Pink Sheet)
  • Gang of 7: Boehringer joins group of companies targeted over drug discount program (Endpoints)
  • Gemini axes CSO and 20% of staff to focus on late-phase plans (Fierce)
  • Vedanta brings home a win for lead microbiome program, passing a PhII test and clinching BARDA investment (Endpoints)
  • Ex-FDA officials ask SCOTUS to take up J&J talc case; Annovis shows data from PhII Parkinson's trial (Endpoints)
  • A month after a manufacturing hiccup led to a CRL, CorMedix CEO will retire (Endpoints)
  • Medicxi co-founder David Grainger gets his other foot in Centessa's door as chief innovation officer (Endpoints)
  • New small molecule player with roots in David Liu's lab collects another $78M to fuel search for exosites (Endpoints)
  • iOmx refuels with $75M+ on its search for immune checkpoint targets on tumor cells (Endpoints)
  • MCIT, cyber, RWE and 3 more takeaways from AdvaMed's 2021 conference (MedtechDive)
  • Hologic begins broad European launch of its tabletop Novodiag tester after its $795M acquisition (Fierce)
  • EU Classification ‘Bible’ Published To Support Risk Class Decision-Making (MedtechInsight)
Government, Regulatory & Legal
  • J&J Unit Must Face Claims Pelvic Mesh Was Defective (Law360)
  • Drugmakers In Zantac MDL Try To Trim Claims (Law360)
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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