Recon: FDA grants accelerated approval to Padcev/Keytruda combo for bladder cancer; Gossamer’s lymphoma trial put on hold following patient deaths

• 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)
• (Endpoints)
• 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)