Recon: AstraZeneca releases positive results on Imfinzi for bladder cancer; Apple gets FDA nod for hearing aid software for earbuds

• 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)