Brent Saunders pivots from Allergan sale to a $460M SPAC, making him an overnight player in one of the hottest money-raising gambits in biotech (Endpoints)
An old Vertex drug gets new life as an Alzheimer's treatment, but human studies still far off (Endpoints)
Opdivo trial offers new insights into how immuno-oncology drugs could be enhanced (Fierce)
After Novartis left, Boehringer bets up to $500M on the field of prescription smartphone apps (Endpoints)
Fasenra shows positive PhIII topline data for nasal polyps, tightening race with GSK's Nucala (Endpoints)
Sanofi's hemophilia drug comes into focus as delays hit a key competitor (BioPharmaDive)
Savara's long-reigning duo both resign in the wake of CF bust (Endpoints)
GSK and J&J alum Vijay Reddy to take control of R&D at Tmunity; Andrew Hirsch exits Agios for CEO job at C4 Therapeutics (Endpoints)
REYVOW™ (lasmiditan) C-V Demonstrated Pain Freedom from Migraine Attacks At 60 Minutes and Up to 48 Hours in New Phase 3 Study (Press)
Daiichi Sankyo Submits Supplemental Application in Japan for Approval of Partial Changes in Usage or Dosage for Anticoagulant Edoxaban (Press)
Medtech
FDA advisers support down-classing bone growth stimulators, in face of industry and lawmaker pushback (MedtechDive)
Thermo Fisher hikes growth forecast, expects COVID-19 sales to top $3B in late 2020 (MedtechDive)
Quest raises 2020 revenue outlook to beat pre-coronavirus goal by 10% (MedtechDive)
BD says its antigen test on par with Quidel's in head-to-head preprint study (MedtechDive)
Bill Advances Mandating Private Insurance Coverage Of Devices To Correct Birth Defects (MedtechInsight)
Government, Regulatory & Legal
Pfizer successful in getting insurer to pay for litigation (legalnewsline)
State AGs Say Drugmakers Want To Delay Price-Fixing Trials (Law360)
US FDA Contracting Update: From Rating Site Quality Maturity To Blocking COVID-19 Scams (Pink Sheet)
Publication of notified medicine shortages: Updated protocol (TGA)
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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