Recon: FDA panel unanimously backs oral OTC contraceptive; FDA rejects ImmunityBio’s application for bladder cancer therapy

• First OTC Oral Contraceptive Has Advisory Panel’s Unanimous Support Despite FDA’s Data Concerns (Pink Sheet) (Endpoints) (Bloomberg)
• FDA declines to approve ImmunityBio's bladder cancer therapy, shares slump (Reuters) (Endpoints) (BioSpace)
• FDA’s nagging doubts about Sarepta’s DMD gene therapy won’t quit as advisory meeting looms (Fierce) (Pink Sheet) (Endpoints)
• Japan's Otsuka Pharma gets FDA approval for Alzheimer's agitation drug (Reuters)
• FDA Approves Fabry Disease Treatment from Chiesi, Protalix (BioSpace)
• US FDA eases restrictions on blood donation (Reuters) (WSJ)
• AI In Drug Development: FDA Wants To Know How To Assure Data Integrity, Transparency, Reliability (Pink Sheet)
• Secret White House Team Tackles Drug Shortages, Quality Woes (Bloomberg)
• Wyden decries ‘astonishingly low’ tax rates for pharma companies as he probes business maneuvers (STAT) (Endpoints)
• ‘Why Stop At Insulin?’ Senate Democrats Want More List Price Moves From Pharma (Pink Sheet) (Endpoints)
• Law on Vaccine Mandates Sparks Doubts for Response to Next Virus (Bloomberg)

• WHO ends global health emergency over mpox (STAT) (Reuters)
• EMA Wants More Data On Pediatric Medicine Acceptability Test (Pink Sheet)
• Companies Vigilant As China Expands Wide-Ranging Anti-Espionage Legislation (Pink Sheet)
• Chinese baby product firms seek to age up, sell more abroad as population falls (Reuters)
• Pakistan Consults On Content Of Patient Information Leaflets (Pink Sheet)

• Teva's new CEO Richard Francis is planning a 'new chapter' for the generics giant (Endpoints)
• Teva Expects To Carve Out Sizable Niche For Uzedy In Antipsychotic Market (Scrip)
• BioNTech swiftly axes oral mRNA vaccine project after tech flunks early test (Fierce) (Endpoints)
• Pancreatic Cancer Vaccine Shows Promise in Small Trial (NYT)
• Fierce Biotech Layoff Tracker 2023: Novavax lays off hundreds; Gossamer lets go 25% of staff (Fierce)
• Germany's Merck flags decline in operating profit of up to 10% in 2023 (Reuters)
• Japan's Takeda flags profit slide as it bolsters drug pipeline (Reuters)
• Xarelto Declines Are New Normal At Bayer (Scrip)
• Martin Shkreli-founded drug company files for bankruptcy (Reuters) (Endpoints)
• Next-gen Lilly obesity drug slashes weight in Innovent study-but is it enough to rival Mounjaro? (Fierce)

• EU AI Act Amendments Get Green Light From Parliament Committees In Latest Vote (MedTech Insight)
• FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech (MedTech Dive)
• Another Hiatus In Notified Body Designations Ahead (MedTech Insight)
• Innovative Spine Surgery Platform Wins FDA Clearance (MedTech Insight)
• Icahn wins proxy firm nod to oust CEO from Illumina board (MedTech Dive)
• Samsung Galaxy Watch joins Apple Watch, Fitbit with FDA nod for afib-warning feature (Fierce)
• Siemens Healthineers profits plummet 81% amid exit from cardiology robotics, slowed COVID test sales (Fierce)
• Philips shareholders vote against freeing execs from legal liability over 2022’s troubles (Fierce)

• Redacted Ruling Details Xspray Failure to End Bristol-Myers Suit (Bloomberg)
• Vanda Patent Loss on Hetlioz Sleep-Disorder Drug Copies Affirmed (Bloomberg)
• Gilead Wins HIV Patent Suit, Nabs Oncology and Inflammation Startup (BioSpace)
• Opioid Money Group Subject to Open Records Laws, Ohio Court Says (Bloomberg)