Recon: FDA panel unanimously backs oral OTC contraceptive; FDA rejects ImmunityBio’s application for bladder cancer therapy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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