Recon: FDA approves Acadia’s Rett syndrome drug; Pfizer to buy Seagen for $43B

ReconRecon | 13 March 2023 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • FDA approves first treatment for Rett syndrome, a genetic neurological disease (STAT) (Reuters) (Endpoints)
  • GSK’s $100M ADC net in doubt after fatality in first trial of Mersana’s cancer therapy (Fierce) (Endpoints)
  • Silicon Valley Bank customers to have all funds accessible, US says, easing biotech and tech turmoil (Endpoints)
  • Bristol Myers, Pfizer, AbbVie drugs likely to face U.S. price negotiation (Reuters)
  • FDA Action Alert: Apellis, Pfizer. Biogen/Ionis (BioSpace)
  • The second age of psychedelic therapies for mental health (STAT)
  • Deaths From PSA-Detected Prostate Cancer Low at 15 Years, no Matter the Treatment (MedPage Today)
  • Prostate cancer treatment can wait for most men, study finds (STAT)
In Focus: International
  • Don’t Reveal Patients’ Safety Data Just Because They Have, Trial Sponsors Told (Pink Sheet)
  • Sanofi throws down $2.9B to acquire diabetes partner Provention Bio (Fierce) (Bloomberg) (Endpoints) (Reuters)
  • EMA Dismisses Claims That RWD Is The ‘Wrong Remedy’ For Drug Development Challenges (Pink Sheet)
  • EMA Wants To Engage With Developers Of Psychedelic Substances (Pink Sheet)
  • EU Wants ‘Written Guarantees’ From UK On New Medicine Rules (Pink Sheet)
  • UK biopharma body praises bank for keeping doors open at life science startups by rescuing SVB UK (Fierce)
Pharma & Biotech
  • Pfizer to buy Seagen for $43B, ending long-running M&A saga for biotech (Endpoints) (Reuters) (MedWatch)
  • Carl Icahn takes proxy fight to Illumina: report (Endpoints) (Reuters)
  • Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study (BioSpace)
  • Calliditas plans to file for full approval for rare kidney disease drug following PhIII data (Endpoints)
  • The top 10 drugs losing US exclusivity in 2023 (Fierce)
  • Report Shows Expected Uptick in Layoffs and Collaboration across BioPharma (BioSpace)
  • Biogen’s Samantha Budd Haeberlein, an architect of Aduhelm, leaves company (STAT)
  • In busy year with Haleon spinoff and Zantac lawsuits, GSK CEO Emma Walmsley scored slight pay raise (Fierce)
  • Silicon Valley Bank’s swift collapse appears to have left established medtech firms untouched (MedTech Dive)
  • Stack Of New And Revised EU MDR and IVDR Guidances In The Pipeline (MedTech Insight)
  • France Latest Country To Introduce Digital Medtech Reimbursement Fast-Track (MedTech Insight)
  • Released: Germany’s Digital Strategy Will Transform Health And Care (MedTech Insight)
  • FDA defends delayed EUA for Lucira Health’s combo COVID and flu test amid ‘misinformation’ (Fierce)
  • Baxter issues urgent correction for ventilation system due to risk of oxygen desaturation (MedTech Dive)
  • FDA’s first ‘safer technologies’ nod goes to Endolumik’s glowing tube to guide weight-loss surgeries (Fierce)
Government, Regulatory and Legal
  • Moderna loses bid to shift liability in COVID-19 vaccine patent case (Reuters)
  • Allergan Tells SCOTUS That Whistleblower Waived Fraud Argument (Bloomberg)
  • Gilead Sciences, after long battle against HIV drug fraudsters, scores $175.2M in judgements (Fierce)
  • Biogen And Millennium May Be Ensnared In Tentacles Of Genentech’s Expired Cabilly Patent (Pink Sheet)
  • Sun Pharma’s $75 Million Deal Gets Nod in Drug Antitrust Case (Bloomberg)
  • Medtech groups lose challenge to digital piracy rule in device repair case (MedTech Dive)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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