Recon: Moderna touts Omicron-targeted bivalent vaccine; EMA lists critical medicines against COVID-19

ReconRecon | 08 June 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Moderna says Omicron-targeted COVID shot shows better response (Reuters) (NYTimes) (STAT) (Moderna)
  • Breast Cancer Drug Trial Results in ‘Unheard-Of’ Survival (NYTimes)
  • Novavax COVID shot, aimed at vaccine skeptics, overwhelmingly backed by FDA panel (Reuters) (STAT)
  • Sanofi's Dupixent gets U.S. approval to treat eczema in young children (Reuters)
  • Eli Lilly’s new diabetes drug continues to show promise as an obesity treatment (CNBC)
  • White House to cut funding for Covid testing to purchase vaccines for fall (NBC)
  • Opinion: Prices for New Drugs Are Rising 20 Percent a Year. Congress Needs to Act. (NYTimes)
  • Two new versions of Omicron are gaining ground in the U.S., according to C.D.C. estimates. (NYTimes)
In Focus: International
  • EMA adopts first list of critical medicines for COVID-19 (EMA) (List)
  • One More EU MDR Notified Body In The Pipeline And Then A Gap (MedtechInsight)
  • More than 1,000 monkeypox cases reported to WHO – briefing (Reuters)
  • Innovation Passport  awarded Alnylam and its hypertension therapy (PharmaTimes)
  • Novavax says COVID vaccine for U.S. to be manufactured by India's Serum (Reuters)
  • Takeda teams with GSK, other drugmakers to track supplier emissions (Nikkei)
Pharma & Biotech
  • DBV patches up prospects with phase 3 win in infants with peanut allergies (Fierce)
  • Opinion: FDA user fee legislation needs to mitigate the pharmaceutical industry’s carbon pollution (STAT)
  • After late-study endpoint switch, Aldeyra hails success of phase 3 dry eye disease trial (Fierce)
  • Astellas joins Pfizer in emerging North Carolina hub, unveiling new $100M gene therapy manufacturing site (Endpoints)
  • With eyes on first allogeneic CAR-T approval, Precision touts 100% response in 'small niche' population (Endpoints)
  • For Rigel, a surprising placebo response spurs a PhIII fail, stock beating. But it's been here before (Endpoints)
  • India Proposes OTC List But Clarity On Pricing, Switching Pathway Awaited (Pink Sheet)
  • RA Capital backs a Philly biotech's $118M crossover as it aims to break into the hypertension space (Endpoints)
  • New survey suggests many Black cancer patients aren't made aware of clinical trials (Endpoints)
  • EQT's investment arm and Mubadala ink $3B deal for medical freight and storage company (Endpoints)
  • German startup jumps into the hot radiopharma space with a former Ipsen compound as lead program (Endpoints)
  • FDA mulls pilot program on alternative sterilization for medical devices (MedtechDive) (MedtechInsight)
  • As monkeypox cases rise, BD pairs up with Spain-based CerTest for diagnostic (Fierce)
  • FDA slaps Class I label on Medtronic latest heart pump recall (Fierce)
  • GE Healthcare’s recall of ventilator batteries gets Class I label from FDA over device shutdown risk (MedtechDive)
  • Expected Spread Of US OTC Diagnostics Could Change Consumers’ Health Care Behaviors (MedtechInsight)
Government, Regulatory & Legal
  • FTC opens investigation into largest PBMs' anticompetitive practices (Endpoints) (STAT)
  • Bristol Myers settles anti-generic HIV drug scheme allegations for almost $11M (Endpoints)
  • Georgia senator urges majority leader Chuck Schumer to follow through on insulin cap legislation (Endpoints)
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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