Recon: Pfizer’s Paxlovid fails to show benefit for COVID prevention; FDA places hold on Vertex’s diabetes study

ReconRecon | 02 May 2022 | By

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer says COVID treatment Paxlovid fails to prevent infection of household members (Reuters) (STAT)
  • Vertex Falls After FDA Halts Diabetes Study in Surprise Move (Endpoints) (STAT)
  • It’s CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News (Biospace)
  • Human testing for Praxis’ lead epilepsy drug held up after FDA clinical hold (Endpoints)
  • US Bridging Study Not Enough as FDA Denies Hutchmed’s Pancreatic Cancer Drug (Biospace)
  • FDA Approves New Nonstimulant Option for Adults with ADHD (Biospace)
  • Sage, Biogen get rolling on FDA submission for depression med (Fierce)
  • US FDA Uses PI3K Inhibitor Experience To Spell Out What It Wants In Dose Optimization Studies (The Pink Sheet)
  • Is Biogen Planning to Appeal CMS Aduhelm Reimbursement Decision? (Biospace)
  • U.S. likely to find out about next COVID booster by summer -Fauci (Reuters)
  • Roche releases more Evrysdi data leading up to FDA decision for very young infants with SMA (Endpoints)
In Focus: International
  • Moderna asks Canada for extension of COVID vaccine to young children (Reuters)
  • Production halted at Korean pharma after regulators find unauthorized additives in 13 drugs (Endpoints)
  • Child hepatitis cases rise in UK amid worldwide outbreak (Reuters)
  • U.S. FDA declines to approve two more China-tested drugs (Reuters)
Coronavirus Pandemic
  • COVID-19 Products Still Vulnerable To Falsification & Diversion (The Pink Sheet)
  • Omicron Sublineages Evade Antibodies From Earlier Infections (Bloomberg)
  • Beijing Expands COVID Testing; Stringent New COVID Policy Coming? (The Pink Sheet) (Reuters)
  • Philippines planning to give Myanmar 5 million Sputnik V vaccines (Reuters)
Pharma & Biotech
  • AbbVie tosses its triplet therapy for cystic fibrosis, leaving Vertex to reign supreme (Endpoints)
  • Stealth stumbles again as age-related macular degeneration joins list of clinical trial flops (Fierce)
  • AstraZeneca will have to wait a little longer for fruit from $3.5B Ionis ATTR partnership (Fierce)
  • Lupin Appoints New Compliance Manager As More Deficiencies Found (Generics Bulletin)
  • Biogen board slashes CEO’s bonus as Aduhelm sales and overall business struggle (STAT)
  • After posting midphase data, Rezolute banks $130M to take treatment for rare disease into pivotal trial (Fierce)
  • Gilead joins a lineup of Big Pharma partners betting big on TriNKETs, with a $300M cash ante to get started on a 5T4 (Endpoints)
  • Researchers take heart from mRNA’s potential to boost recovery from cardiac attack (Fierce)
Medtech
  • How The EU Needs To Address Conflicts Between AI and Medical Device Rules: Part 2 (Medtech Insight)
  • CDRH’s Shuren expects center to return to normal this year despite ongoing COVID work (MedTech Dive)
  • Celltrion tack on a third Class I recall for unauthorized use of rapid COVID tests (Fierce) (MedTech Dive)
Government, Regulatory & Legal
  • Law firm files class action against pharma company Natera (Reuters)
  • Hearing Aid Company Settles Claims Allegations for $34 Million (Bloomberg)
  • Pharma in the Courts: Purdue Settlement Trudges On, Walgreen’s Battles Opioid Suit (Biospace)
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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