FDA sends small biotech and its reformulated pain med packing, triggering a collapse in the share price (Endpoints)
‘We have to deal with uncertainty’: FDA leaders explain how Covid-19 has upended cancer research and care (STAT)
Time For Independent FDA? COVID-19 Political Pressure Reignites Debate (Pink Sheet)
OxyContin Abuse-Deterrent Postmarketing Data Are In. Now What? (Pink Sheet)
EU Regulatory Network 'Competing With Google' For Tech & AI Experts (Pink Sheet)
French To Speed Up Early Access Procedure (Pink Sheet)
UK MHRA Picks Pharmacovigilance For First AI Guideline (Pink Sheet)
Bob Langer-backed spinout shoots for $75M-plus IPO while biotech SPACs continue to rule on Wall Street (Endpoints)
News briefing: Gilead reveals more filgotinib data; Seagen and Astellas report new cohort for Padcev (Endpoints)
Lilly shows more positive Crohn's data for its IL-23 inhibitor as it continues to chase down rivals (Endpoints)
Novartis vets get $35M to pluck one of the pharma giant’s abandoned drugs off the shelf and put it back into a clinical trial (Endpoints)
Sami Anwar raked in millions of dollars gathering drug trial data at his sites. But it was all a lie — and now he's been sentenced to 28 years (Endpoints)
Medtech
5 key exec insights from 2020's MedTech Conference (MedtechDive)
Olympus to roll out colonoscopy AI for spotting lesions, polyps in real time (Fierce)
HIMSSCast: Is the FDA taking digital health regulation in the right direction? (Mobihealthnews)
Government, Regulatory & Legal
Negotiation Class Wants 6th Circ. Full Review In Opioid MDL (Law360)
J&J Opens Appeal By Assailing 'Radical' $465M Opioid Verdict (Law360)
Drug Cos. Fight Class Cert. For 'Opioid Babies' In MDL (Law360)
Prosthetic Maker Reaches Deal Over FTC's Merger Unwinding (Law360)
Allergan Escapes Ill. Suit Over Defective Breast Implants (Law360)
Eye Device Maker Gets Rival Product Blocked During IP Fight (Law360)
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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