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