Recon: FDA grants accelerated approval to Padcev/Keytruda combo for bladder cancer; Gossamer’s lymphoma trial put on hold following patient deaths
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Seagen, Merck's Padcev-Keytruda combo snags FDA accelerated approval for bladder cancer (Endpoints) (BioSpace)
- Arbutus files patent infringement lawsuit against Pfizer/BioNTech over COVID shots (Reuters)
- Gossamer halts work on BTK inhibitor after 2 patient deaths (Fierce) (BioSpace)
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- FDA to okay second omicron-targeting booster for some, officials say (Washington Post)
- Phathom says it has Voquezna back on track after nitrosamine-related delay (Fierce)
- Camber recalls pneumonia drug, citing possible microbial contamination (Fierce)
- US FDA Exploring Consortium To Develop Treatments For ‘Economically Infeasible’ Cancer Indications (Pink Sheet)
- Warning Letters Special Report: Pandemic Drove Focused Inspections, Alternative Approaches (Pink Sheet)
- Pharma Industry Wants USPTO To Hit Brakes On Changes To Patent Continuation Practice (Pink Sheet)
- More than half of accelerated approval confirmatory trials are late, researchers write in JAMA (Endpoints)
- 5 FDA decisions to watch in the second quarter (BioPharma Dive)
- Pharma fees to European regulator spike thanks to 10% inflation rate (Endpoints)
- WHO says infertility affects 1 in 6 globally, calls for more consistent data (Reuters) (STAT) (Bloomberg)
- India tests of eye drops linked to US deaths show no contamination – NDTV (Reuters)
- World making ‘huge mistake’ not funding new TB vaccines – Gates (Reuters)
- How To Make International Pull Incentives Work In Fight Against AMR (Pink Sheet)
- China Data Protection, Cross-Border Transfers Enter New Chapter (Pink Sheet)
- Australian Regulator Explains How To Comply With Advertising Rules While Meeting Continuous Disclosure Obligations (Pink Sheet)
- Pfizer, Merck trim prices in China for Paxlovid, molnupiravir – reports (Reuters)
- Novo Nordisk to halt Ozempic sales in Russia, says drug authority (MedWatch)
- Lilly Debuts next Alzheimer’s Drug, Will Test Subcutaneous Potential (BioSpace)
- Seeking full approval in Alzheimer’s, Eisai dives into prominent Leqembi side effect (Fierce)
- Exclusive: Oncology startup from Sanger Institute nabs $28M, ex-Novartis SVP as CEO (Endpoints)
- Ginkgo partners up with Sensible Biotechnologies to forge mRNA manufacturing platform (Endpoints)
- Survey says drug commercialization should stretch back, incorporate digital insights for doctors (Endpoints)
- Cure Ventures Launches with $350M to De-Risk Innovation (BioSpace)
- Sanofi: Hemophilia Drug Trial Data Highlight Broad Use Potential (Bloomberg)
- Intellia Seeks to Broaden Gene Editing’s Potential with Full-Spectrum Approach (BioSpace)
- From a public library whiteboard, a $350 million biotech venture fund (STAT)
- Freeline keeps up cadence of quarterly cuts, canning another 30% of its staff months after last layoffs (Fierce)
- Why the early tests of ChatGPT in medicine miss the mark (STAT)
- Masimo receives FDA clearance for first opioid overdose prevention monitor (Fierce) (MedTech Insight) (MedTech Dive)
- EHDS Data Sharing Rules Are Good News For Medtech, But Is The Public On Board? (MedTech Insight)
- Philips Trilogy Evo ventilators face another Class I recall (MedTech Dive)
- Butterfly nets AI ultrasound clearance for spotting signs of lung disease (Fierce)
- FDA approves biodegradable metal screw implant for fixing broken bones (Fierce)
- Louisiana Court Dismisses Insulin Pump Defection Case As Claims ‘Twiqballed’ (MedTech Insight)
- Arbutus files patent infringement lawsuit against Pfizer/BioNTech over COVID shots (Reuters)
- Sandoz to pay Allergan, Duke University $39M over eye drug lawsuit, jury says (Endpoints) (Fierce)
- Bayer defeats Merck in lawsuit over talc liabilities (Reuters) (Bloomberg)
- Advocates Say Preventive Care Ruling Could Harm Patients And Innovation (MedTech Insight) (Endpoints)
- Eighth Circuit Lets Drugmakers Challenge Free Insulin Program (Bloomberg)
- Opioid Victims Wait as Second Circuit Mulls Purdue Pharma Deal (Bloomberg)
- Direct Biologics Gets New Look in Noncompete, Trade Secrets Case (Bloomberg)
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