Recon: States sue to stop cuts to NIH research funds; AbbVie nabs FDA approval for novel antibiotic
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 22 states sue to block Trump administration cuts to NIH research payments (STAT)
- Senators ask FDA to dig into 'misleading' Super Bowl ad from Hims (Endpoints)
- AbbVie wins FDA approval for new antibiotic to treat complex intra-abdominal infections (Endpoints)
- Q4 earnings updates; Biogen details revised research strategy; RFK Jr. advances out of Senate committee; and more (Endpoints)
- TB, malaria, newborn health services must restart, says USAID memo (Reuters)
In Focus: International
- Post-Hoc: China tensions both help and hurt Illumina (Endpoints)
- Exclusive: Germany's Merck n talks to buy US biotech firm Springworks, sources say (Reuters)
- Indonesia launches $183 million free health screening to prevent early deaths (Reuters)
- India's Adani ties up with US-based Mayo Clinic for affordable health campuses (Reuters)
- China's health regulator defends quality of local generic drugs (Reuters)
- Post-Market Surveillance: The Rock On Which UK’s Global Regulation Ambitions Will Be Built (MedTech Insight)
- EU Clarifies AI System Definition, Including Specific Medical Technologies (MedTech Insight)
Pharma & Biotech
- The life sciences industry needs a new approach (STAT)
- Amid shakeup in U.S. science, researchers express alarm over integrity of key genetic databases (STAT)
- Boehringer Ingelheim touts success in second Phase 3 lung fibrosis trial (Endpoints)
- Decade after $8B deal, Roche offloads InterMune to mysterious specialty pharma (Endpoints)
- Roivant discontinues lung disease drug; Bio-Thera, Intas make biosimilar deal (Endpoints)
- Pliant pauses Phase 2b lung fibrosis study after safety board recommendation, shares plummet (Endpoints)
- Sanofi, AstraZeneca back Teva's call to rehear case on patent listings (Endpoints)
- Sionna inks $191M IPO for cystic fibrosis pipeline as Aardvark eyes $89M for its own listing (Endpoints)
- Incyte forecasts downbeat annual sales of skin disease drug, shares fall (Reuters)
Medtech
- New Teladoc, same acquisition strategy (STAT)
- Two biotechs say they’re using AI to conjure drugs from scratch. Their documents suggest otherwise (STAT)
- FDA posts early alert about BD device linked to 30 injuries, 4 deaths (MedTech Dive)
- M&A and a separation take center stage in latest earnings season (MedTech Dive)
- Why health systems should be ‘clear-eyed’ about business goals for AI tools (MedTech Dive)
Government, Regulatory & Legal
- Here’s how big a hit some universities may take if NIH slashes support for indirect research costs (STAT)
- The FDA’s misguided thinking on antibiotics (STAT)
- Indirect research costs are complicated, wonky — and crucial to science (STAT)
- A check-in on health insurers’ medical costs, and more babies are being born (STAT)
- Major FDA staff cuts would slow drug reviews, experts say (Endpoints)
- Health clinics grapple with US funding squeeze (Reuters)
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.
