Recon: FDA rejects Fortress, Zydus’ Menkes disease drug over GMP concerns; Jazz wins expanded FDA approval for lung cancer combo
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US FDA approves Jazz Pharma's combination therapy for lung cancer (Reuters)
- Fights over Tylenol, SSRIs highlight the enduring lack of pregnant women in drug trials (STAT)
- Government shutdown set to furlough more than 32,000 at HHS, hamper CDC, CMS communication (STAT)
- US FDA declines to approve Fortress Bio and Zydus' treatment for a rare pediatric disease (Reuters)
- Leucovorin has a place in autism treatment, researcher says, but he tamps down parents’ expectations (STAT)
- Trump targets deals in pharma, AI, energy, mining before midterm elections (Reuters)
- US Pfizer deal powers health stocks as drugmakers court Trump (Reuters)
- Despite shutdown, companies still plan to submit upcoming FDA applications (Endpoints)
- WHO says the antibacterial pipeline reveals a dual crisis: scarcity and lack of innovation (STAT)
- U.K. is urged to probe drugmakers for conspiring to scrap or halt investments amid pricing disputes (STAT)
- Novo, Lilly weight-loss drugs should be first option obesity treatments, European doctors say (Reuters)
- Biotech IPOs in Hong Kong far outpace the US driven by China’s buzzy biotech sector (Endpoints)
- EU Begins To Define Secondary Uses Of Health Data Under EHDS (MedTech Insight)
- Amgen says its cholesterol shot prevented heart problems in a broad population (STAT)
- The biotech scorecard for the fourth quarter: 36 stock-moving events to watch (STAT)
- Behind-the-scenes details of 89bio's $2.4B deal with Roche (Endpoints)
- Biotechnology firm Galapagos receives offers for cell therapy business (Reuters)
- A year after collaborating with Gilead, Cartography maps out its own Phase 1 with $67M Series B (Endpoints)
- Taysha may file for approval sooner than expected; Metagenomi ends work with Affini-T (Endpoints)
- A long-trusted physician’s reference finally catches the AI wave (STAT)
- Hans Scientific invests $2B in US to avoid tariffs; Thermo Fisher inks up to $1B contract (Endpoints)
- Koda Health raises $7M for advanced care planning software (Endpoints)
- Boston Scientific aims for market leadership in electrophysiology (MedTech Dive)
- Distalmotion adds hysterectomy indication; AiM raises funds for neurosurgical robot (MedTech Dive)
- Boston Scientific unveils plans for new Watchman device (MedTech Dive)
- After ‘Success’ Of Early Alert Pilot, FDA Builds Out Program To Include All Devices (MedTech Insight)
- US government shutdown threatens food-aid program for low-income Americans (Reuters)
- 4 dead in listeria outbreak possibly linked to pasta meals (The Hill)
- The U.S. House Introduces Bill to Expand Compounding During Drug Shortages, Provide Clarity on Bulk Substance “USP/NF Monograph” Definition, and Get Rid of Section 503A’s Tortured MOU Provision (FDA Law Blog)
- Why promising women’s health companies die so often (STAT)
- Humana sees 20% of its members in high-rated Medicare plans (Reuters)
- Whistleblower Suit Against UnitedHealth Continues After Semler, Bard Settle Related Cases (MedTech Insight)
- Vanda ends lawsuits against FDA as part of wide-ranging agreement with agency (Endpoints)
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