Exclusive: AstraZeneca’s outgoing R&D chief Mene Pangalos reflects on a 14-year R&D turnaround and the industry's future (Endpoints)
Galera Therapeutics to cut 70% of staff in wake of rejection for radiotherapy complication treatment (Endpoints)
Emergent commits to layoffs and C-suite trimmings, no longer focusing on CDMO activity (Endpoints)
Novartis Scores Phase III Chronic Hives Wins as Sanofi Challenges (BioSpace)
Mirati CEO Steps Down After Going Toe-to-Toe with Amgen in KRAS (BioSpace)
Bluebird Pins Hopes on Zynteglo Uptake, FDA Verdict Amid Cash Constraints (BioSpace)
Regeneron's high-dose Eylea shows staying power as company awaits FDA decision (Fierce Pharma)
Dyslipidemia space to 'undergo a massive shake-up,' but pharmas must price new drugs carefully: report (Fierce Pharma)
Despite mounting failures, analysts see NASH market as holding 'enormous untapped potential' (Fierce Pharma)
Elevidys Clinical Development: Confidence In Surrogate Endpoint A Longstanding Concern For FDA Reviewers (Pink Sheet)
Medtech
Boston Scientific receives FDA approval for cryoablation system (MedTech Dive)
Device volumes to hold up against threat of Wegovy, other GLP-1 drugs: analysts (MedTech Dive)
Stryker touts Mako robot in DTC ads, as device makers eye broader patient populations (MedTech Dive)
Elon Musk’s brain implant company raises $280M to fund clinical trials (MedTech Dive)
Guardant, Illumina agree to end litigation, extend commercial partnership (MedTech Dive)
July Warning Letter Prompts Pause In Dialysis Accessory Distribution (MedTech Insight)
Government, Regulatory & Legal
CDC director overhauls leadership of center that oversaw response to Covid-19 (STAT)
Companies Advised To ‘Re-Think’ SPC & Regulatory Strategies For ‘Loose’ Combination Products (Pink Sheet)
Genentech to pay $158K fine after EPA flagged mishandling of hazardous waste at San Francisco plant (Fierce Pharma)
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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.