Recon: AstraZeneca releases positive results on Imfinzi for bladder cancer; Apple gets FDA nod for hearing aid software for earbuds
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- News from ESMO: An AstraZeneca win in bladder cancer, and more (STAT) (Endpoints)
- Pfizer drug shows promise in cancer-related condition that causes weight loss and weakness (STAT)
- In surprise, study suggests Covid mRNA vaccines may boost cancer immunotherapy efficacy (Endpoints)
- Sanofi, AstraZeneca win US approval for RSV therapy manufacturing line (Reuters)
- Intercept’s Ocaliva Falls At US FDA Panel; Is Accelerated Approval Withdrawal On The Horizon? (Pink Sheet)
- Saudi Arabia To Mandate Economic Evaluation Studies For New Drugs From July 2025 (Pink Sheet)
- No UK Approval Filing For Biogen's Tofersen Because Of NICE HTA Decision (Pink Sheet)
- EU Acknowledges Demand For Psychedelic Drug Development Progress: One Million Signatures Now Needed (Pink Sheet)
- German Industry Concerned It Will Be Hung Out To Dry By EU Wastewater Directive (Pink Sheet)
- Can iTeos and GSK solve TIGIT’s troubles? (STAT)
- Genentech, a biotech with a storied past, confronts new turbulence in the present (STAT)
- Incyte’s checkpoint inhibitor staves off disease progression in anal cancer trial (STAT)
- AstraZeneca’s Imfinzi increases survival rates in bladder cancer in pivotal study (STAT)
- Exelixis’ drug staves off neuroendocrine tumor progression in broad swath of patients (Endpoints)
- Biotech IPO market still in flux following flashy Friday tripleheader (Endpoints)
- Ex-Kite leaders step in at Kyverna as CEO exits after landing year's second-biggest IPO (Endpoints)
- Immatics loses Bristol Myers' support on Phase 1 bispecific T cell engager (Endpoints)
- Merck's Eliav Barr on subcutaneous Keytruda, Summit and deal shopping (Endpoints)
- Physical therapy startup Sword Health shifts to a novel way of getting paid (Endpoints)
- Keytruda and Lenvima still have another hill to climb following latest data drop (Endpoints)
- Scorpion details early data on targeted breast cancer drug as it seeks to challenge Novartis, Roche (Endpoints)
- TPG-backed Bicara Therapeutics raises $315 mln in US IPO (Reuters)
- Zenas BioPharma raises $225 mln in US IPO (Reuters)
- Apple will offer millions of AirPod users a hearing aid. Can it convince them to use it? (STAT)
- Exact Sciences reports initial positive results in colon cancer blood test, but pivot trial still pending (STAT)
- Boston Scientific, Silk Road expect to close merger in ‘coming days’ (MedTech Dive)
- Inflammatix raises $57M to advance test for infection, sepsis (MedTech Dive)
- Baltimore to take drug distributors to trial over opioids (Reuters)
- Walgreens paying $106.8 million to settle US prescription billing fraud charges (Reuters)
- 23andMe settles data breach lawsuit for $30 million (Reuters)
- US FDA Review Of Akebia’s Vafseo Informed By Roxadustat, Daprodustat Safety Concerns (Pink Sheet)
- Who Will Reap The BIOSECURE Spoils? US Industry Boost Not Guaranteed (Pink Sheet)
- The Greatest Trick the Devil Ever Pulled was Convincing the World He Didn’t Exist: Senate Judiciary Set to Mark-Up Patent Reform Bills that Could Significantly Affect Hatch-Waxman and the BPCIA (FDA Law Blog)
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.
