For two decades, the FDA approval process for opioids had numerous shortcomings, study finds (STAT)
Brent Saunders rides $400M wave to the top of the SPAC boom (Endpoints)
RNAi trailblazer Alnylam teases more positive data for a potential third commercial drug (Endpoints)
A pharma exec gets $100M to chase a cancer-fighting idea uncovered in a 2017 Novartis study (Endpoints)
News briefing: Ovid shows mixed results on epilepsy program; Iliad reports positive whooping cough data (Endpoints)
BARDA boosts the fight against antibiotic-resistant infections with $144M awards (Endpoints)
Jeffrey Bluestone recruits a trio of biopharma vets to the startup team at Sonoma — while adding $30M to the launch round (Endpoints)
Medtech
Medtronic to expand dialysis access position with Avenu Medical buyout (MedtechDive)
Medtech M&A exploded in August and September. Will 2020 go out with a bang? (MedtechDive)
Smith & Nephew inks $240M deal to buy orthopaedic assets from Integra (MedtechDive)
Head Of New Digital Health Center Looking For A Few Good FDA Staff (MedtechInsight)
Government, Regulatory & Legal
Judge allows $1.5 billion Tamiflu stockpiling lawsuit against Roche to go ahead (Pharmafile)
Surgery Robot Maker Accused Of Banning Third-Party Repairs (Law360)
J&J, Mallinckrodt Push For Stay Of NY Opioid Fraud Cases (Law360)
3rd Circ. Vexed By Vagueness In Abbott Artery Device Suit (Law360)
Full Fed. Circ. Won't Undo Sandoz Loss In Patent Fight (Law360)
Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 2020) (Patent Docs)
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.
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