Regulatory Focus™ > News Articles > 2022 > 5 > Recon: Pfizer, BioNTech seek vaccine EUA for children under 5; EU authorizes AstraZeneca COVID boost

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Posted 23 May 2022 | By Michael Mezher 

Recon: Pfizer, BioNTech seek vaccine EUA for children under 5; EU authorizes AstraZeneca COVID booster

2786 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer/BioNTech to seek Covid vaccine authorization for children under age 5 (STAT) (Reuters)
  • White House sees decision on Moderna COVID shot for kids under 5 in next few weeks (Reuters)
  • U.S. FDA sets June meeting dates for Moderna, Pfizer small children COVID-19 vaccines (Reuters)
  • AbbVie asks FDA to approve Parkinson’s treatment (BioPharmaDive)
  • Vir, WuXi Biologics terminate COVID antibody pact as US rollout faces uncertain future (Fierce)
  • FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder (FDA)
  • FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia (FDA)
  • Pfizer to refund $290,000 to consumers in four states over misleading copay coupons (STAT)
  • Moderna’s Vaccine Patent Defense Poses Shield for US Deal Makers (Bloomberg Law)
  • U.S. drug regulator lifts clinical hold on Ocugen's COVID vaccine trial (Reuters)
  • U.S. Task Force to consider routine kidney disease screening (Reuters)
  •  
  • 'I really don’t look back': Janet Woodcock on her transition away from drugs (Endpoints)
In Focus: International
  • Big Pharma lobbies for slice of G20 fund to prepare for next pandemic (FT) (Reuters)
  • Cancer coalition aims to boost access to medicines in poorer countries (Reuters)
  • AstraZeneca says EU regulator approves COVID shot as booster (Reuters)
  • Sanofi's Xenpozyme, Lilly's Olumiant among batch of new EU approvals (Fierce)
  • European regulator suspends generic drugs after finding flawed studies (STAT)
  • PTC’s first gene therapy gains European regulator’s backing (BioPharmaDive) (Endpoints)
  • WHO chief says it must take central role in global health (Reuters)
  • WHO expects more cases of monkeypox to emerge globally (Reuters)
Pharma & Biotech
  • Biohaven's drug for neurological disease fails late-stage study (Reuters) (Fierce)
  • A Daily Aspirin Regimen May Hurt More Than Help, Experts Warn (NYTimes)
  • J&J's $230M blood pressure bet hits phase 3 endpoint, but questions linger about blockbuster potential (Fierce)
  • Chasing Lilly and Pfizer, Concert's JAK inhibitor hits high notes in phase 3 alopecia trial (Fierce)
  • Innoviva buys struggling antibiotic biotech Entasis, as the AstraZeneca spin out preps FDA filing (Fierce)
  • Fujifilm continues its biotech building spree with new facility in China (Endpoints)
  • What drug categories spend the most on advertising? Diabetes, psoriasis and arthritis top the list (Endpoints)
  • One trial down, one to go as Concert Pharmaceuticals tunes up PhIII win for alopecia drug (Endpoints)
  • Alcon takes a crack at multibillion-dollar dry eye market, picks up 2 drugs from Langer spinout (Endpoints)
  • Sanofi and Regeneron clear the finish line in an inflammatory esophagus disease, leaving Takeda in the dust (Endpoints)
  • Sun Pharma recalls 10,000 bottles of generic anti-depression drug in US after customers report 'grey particles' (Hindustan Times)
Medtech
  • Edwards posts 97% success rate with tricuspid device in 30-day test as it prepares for Abbott rival (MedtechDive)
  • ‘No real clear path’: Insurance coverage for cutting-edge diagnostics remains a major challenge for personalized medicine (STAT)
  • A vibrating pill for constipation heads to the FDA after completing phase 3 study (Fierce)
  • Philips Breathing Machines Recall: 21,000+ Adverse Events Reported To FDA In 1 Year (MedtechInsight)
  • NeuroMetrix Gets FDA De Novo Authorization For Neuromodulation Device To Treat Fibromyalgia (MedtechInsight)
  • Fractyl shows its intestine-resurfacing device for Type 2 diabetes improves insulin resistance, pancreatic function (Fierce)
  • EU MedTech Forum 2022: Regulatory Unpredictability Spurs Renewed Calls For Devices Agency (MedtechInsight)
  • MHRA ‘Aware Of UK Cliff Edge’ In Post-Brexit Devices Regulation Plan (MedtechInsight)
  • Sleepio becomes first digital therapeutic to receive NICE guidance (mobihealthnews)
  • One year into Philips' ventilator foam recall, FDA tallies 124 deaths, 21,000 complaints (Fierce)
Government, Regulatory & Legal
  • Gilead Loses Patent Case Over Lexiscan Generic (Law360)
  • Bipartisan trio of senators ask FTC to look at PBMs and tactics to keep insulin prices high (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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