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