Recon: Pfizer in talks to acquire Seagen; EMA backs approval for 8 new drugs

ReconRecon | 27 February 2023 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer in Talks to Acquire Seagen in Deal Likely Valued at More Than $30 Billion (WSJ) (BioPharma Dive) (Endpoints)
  • Pfizer’s Paxlovid to Face FDA Advisory Panel Meeting on March 16 (Bloomberg) (Endpoints)
  • After ACIP Gambit, Pfizer, GSK Take RSV Vaccines To US FDA Adcomm (Pink Sheet)
  • Pfizer spinout SpringWorks gets FDA priority review for lead drug (Endpoints)
  • Fulcrum’s Clinical Hold Highlights Tough Road in Sickle Cell Space (BioSpace) (Endpoints) (Fierce)
  • FDA’s Billy Dunn, key figure in approval of Aduhelm, to leave agency (STAT) (BioPharma Dive)
  • Doctors who touted ivermectin as covid fix now pushing it for flu, RSV (Washington Post)
  • US to Limit Telehealth Prescriptions to Fight Opioid Addiction (Bloomberg)
  • Covid-19 Lab Leak Viewed as More Likely by US Agency, WSJ Says (Bloomberg)
  • For Cytokinetics, an FDA rejection of its heart drug would help, not hinder (STAT)
  • ACIP Backs Transition To Bivalent COVID-19 Vaccine, Flexibility On Number Of Annual Doses (Pink Sheet)
  • 12 states sue FDA to make abortion pill more accessible to (Washington Post) (STAT)
  • Extensively Drug-Resistant Shigellosis on the Rise in the U.S. (MedPage Today) (Washington Post)
  • Little transparency, lots of waste: NIH funds pediatric research, but many trials results go unpublished (STAT)
In Focus: International
  • European regulators recommend rejection of Merck’s Covid-19 drug molnupiravir (Endpoints)
  • EMA Backs Approval For Eight New Drugs But Rejects Lagevrio For COVID-19 (Pink Sheet)
  • Sponsors Under Fire For Excessive Data Redactions & Deferrals In EU Clinical Trials Portal (Pink Sheet)
  • Antimicrobial Exclusivity Vouchers ‘The Only Way To Go’ (Pink Sheet)
  • Medicines ‘Must Not Fall Off The Radar’ In Northern Ireland Protocol Talks (Pink Sheet)
  • Shionogi sees COVID pill reaping $2 billion in annual sales upon U.S. approval (Reuters)
  • U.S. trade rep urged not to sanction countries if they sidestep patents on Vertex cystic fibrosis drugs (STAT)
  • Canadian drug price board member resigns over government failure ‘to support real change’ (STAT)
Pharma & Biotech
  • Ahead of FDA decision, Blueprint puts out full data for expanded Ayvakit label (Endpoints)
  • Dr. Reddy's to buy Mayne Pharma’s US generics drug list for at least $90M (Endpoints)
  • After spending $6.5B for Momenta, J&J readies ‘pipeline in a product’ for pivotal year (Fierce)
  • CSL, seeking to stall Takeda drug, links antibody to rare disease benefits and plans global filings (Fierce)
  • Months after going public, Apexigen lays off 55% of staff and considers exit routes (Fierce)
  • Glenmark's biotech company Ichnos Sciences lays off 50 (Endpoints)
  • Keytruda killer: Chipscreen bags Chinese rights to Biocytogen’s bispecific antibody (Fierce)
  • Promising growth next year, Viatris names Celgene vet Scott Smith its next CEO (Fierce)
  • Ready for retirement, Juan Andres is waving goodbye to Moderna in May (Endpoints)
  • Proposal To Amend MDR/IVDR May Pass ‘Final Step’ Before Adoption Next Week (MedTech Insight)
  • EUA For First At-Home Kit Differentiating COVID-19 From Flu Could Make Difference In Firm’s Survival (MedTech Insight)
  • Industry Calls For Single Conformity Assessments To Cover EU MDR, EHDS And AI Act (MedTech Insight)
  • How Quality Labels Can Unleash The Potential Of Health Apps In EU And Beyond (MedTech Insight)
  • Medtronic links MiniMed 780G automated insulin delivery to sustained glucose control benefits (MedTech Dive)
  • Olympus mounts $370M bid to acquire GI stent maker Taewoong Medical (Fierce)
  • 3D-printed hearts made from real patient data could pump up accuracy of TAVR implants (Fierce)
Government, Regulatory and Legal
  • Jazz Pharma ruling clears U.S. roadblock for rival narcolepsy drug (Reuters) (Bloomberg)
  • GSK's bellwether Zantac court date pushed to July (Endpoints)
  • U.S. Supreme Court snuffs company challenge to Los Angeles flavored-tobacco ban (Reuters)
  • Cigna Settles Claims of Inflated Laboratory Services (Bloomberg)
  • U.S. trade rep urged not to sanction countries that sidestep Vertex patents (STAT)
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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