Recon: Pfizer, BioNTech to request EUA for COVID booster for children 5-11; Merck’s pneumococcal vaccine wins breakthrough designation from FDA
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Pfizer to seek Covid booster for healthy 5- to 11-year-olds (STAT) (Bloomberg) (Washington Post)
- Merck wins breakthrough therapy designation for potential pneumococcal vaccine successor (Endpoints) (Fierce)
- FDA delays decision on Regeneron/Roche COVID antibody therapy (Reuters)
- Twist in Protagonist story as FDA seeks to rescind breakthrough nod ‘based on observed malignancies’ (Fierce) (Endpoints)
- Another batch of insulin recalled by Viatris due to a labeling issue (Endpoints)
- Califf Says Opioid Labeling Changes, Withdrawals Still Possible (The Pink Sheet)
- Justice Department probes Bausch Health over marketing for dermatology drugs (STAT) (Endpoints)
- Bipartisan group of lawmakers call on 7 manufacturers to make opioid overdose antidote OTC (Endpoints)
- Medicare Restrictions On Aduhelm Do Not Signal Broad Concern With Accelerated Approvals – CMS (The Pink Sheet)
- Britain approves Moderna's COVID shot for 6-11 year-olds (Reuters)
- Poorer nations shun AstraZeneca COVID vaccine – document (Reuters)
- Top EU Regulator Attacks Complexity & Duplication In European System (The Pink Sheet)
- EU Clinical Trial Sponsors Reassured On Member State Dossier Requirements (The Pink Sheet)
- Valneva’s COVID-19 Vaccine Approved In UK While Talks Continue Over Scrapped Supply Deal (The Pink Sheet) (Bloomberg)
- Canada authorizes AstraZeneca's drug for COVID prevention (Reuters)
- Good Clinical Practice Inspections Take On Narrower Focus During Pandemic, US FDA Says (The Pink Sheet)
- China Biotechs See Manufacturing Disruption As Cases Hit Suzhou (Scrip)
- Covid Vaccine Making in Africa Faces Setback on Lack of Orders (Bloomberg)
- Worldwide COVID cases surpass 500 mln as Omicron variant BA.2 surges (Reuters)
- Many Virus Cases Go Uncounted. Are There Better Ways to Track the Pandemic? (NYT)
- Magenta feels the biotech blues, announces layoffs and clinical trial cuts (Endpoints)
- Chasing Roche, AbbVie posts data on CD20 blood cancer bispecific ahead of race to regulators (Fierce)
- 'Empathy and love were not shown’: The story behind Taysha’s layoffs, one of dozens of biotechs suffering this year’s bear market (Endpoints)
- Education can speed enrollment, says organization behind new Clinical Trial Guide (Fierce)
- Majority of diagnostic companies still implementing IVDR as deadline nears: survey (MedTech Dive)
- German IVD Industry’s Commercial Progress: A Case Of ‘Light And Shade’ (MedTech Insight)
- Pear's VR product for postoperative pain granted FDA STeP designation (MedTech Dive)
- Minute Insight: FDA Clears Fitbit Irregular Heart Rhythm Notification Feature (MedTech Insight)
- Boston Scientific infuses €100M into Ireland facility for carbon-neutral manufacturing (Fierce)
- Bristol-Myers Has $11 Million Antitrust Deal on Gilead HIV Drugs (Bloomberg)
- US judge rules that 'Texas two-step' bankruptcy can't help J&J stop a new proposed talc lawsuit (Endpoints)
- Balwani Jury Can See Theranos’ Failed Deals With Military (Law360)
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