Recon: Eli Lilly to invest $27B in US drug manufacturing; India’s CDSCO to streamline export processes
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- The Trump years will be grim for long Covid sufferers (STAT)
- New York congressman launches examination of UnitedHealth clinics in Hudson Valley (STAT)
- FDA cancels vaccine advisory committee meeting (STAT)
- Why NIH pays universities far more for indirect costs than private foundations (STAT)
- Eli Lilly announces $27 billion investment in U.S. drug manufacturing sites (STAT)
- Trump Administration Orders Bird Flu Shot Review (Bloomberg)
- Medicare spending on common diabetes drugs skyrocketed, HHS inspector general finds (Endpoints)
- Despite WHO exit plan, US still in Americas health agency (Reuters)
- With RFK Jr. in Charge, Supplement Makers See Chance to Cash In (Medpage Today)
- Services collapsing as USAID cuts health contracts worldwide (Reuters)
- Q&A: How Trump’s USAID freeze halted the effort to develop an effective HIV vaccine in Africa (STAT)
- Mpox Strain With Higher Transmission Rate Circulating in Congo (Bloomberg)
- Healthcare experts urge India to rewrite clinical trial rules to boost global market share (Reuters)
- India's drug regulator to streamline export process to reduce workload (Reuters)
- India's contract drug makers seek government support in China fight (Reuters)
- New kids on the block: A new generation of VCs ventures into biotech (STAT)
- How to eliminate biotech zombies: Buy them (STAT)
- Novavax's quarterly loss shrinks as it ramps down spending on COVID vaccines (Reuters)
- Can Bill Anderson save Bayer? (Endpoints)
- Hansoh ends collaboration with Silence; Vir hunts for HBV drug partner (Endpoints)
- Merck mulls new site in Delaware; Granules India buys peptide CDMO (Endpoints)
- Kallyope quietly reports Phase 2 obesity data, begins mid-stage migraine trial (Endpoints)
- Startup working on oral antibodies shares early ulcerative colitis data (Endpoints)
- After rejection, Regeneron seeks accelerated approval of bispecific for only one of two types of lymphoma (Endpoints)
- AstraZeneca’s SERD hits primary endpoint in late-stage trial, but first-line potential remains uncertain (Endpoints)
- ‘Fear and uncertainty’: Biotech investors warn of impact from NIH research cuts (MedTech Dive)
- Teladoc reports $1B net loss as it works to turn around its business (Endpoints)
- Staar Surgical to lay off 115 people in California (MedTech Dive)
- CAP urges HHS to revoke lab developed test rule, citing Trump order (MedTech Dive)
- EU Law First Up As UK MHRA Reopens Work On Pre-Market Medtech Regulation (MedTech Insight)
- Seonix Bio’s Newly Launched Saliva-Based Genetic Test Aims To Shed Light On Glaucoma Risk Assessmentb (MedTech Insight)
- Government Cuts ‘Penny-Wise, Pound-Foolish,’ Rare Disease Advocates Fret (MedTech Insight)
- CDC will no longer process transgender data (STAT)
- There’s a better way to get drugs on the market: progressive approval (STAT)
- Medicare Advantage enrollment growth slows drastically (STAT)
- Texas measles outbreak marks first fatality as more cases reported (STAT)
- Trump administration takes aim at bird flu. For now, the cattle will have to wait (STAT)
- How ultra-processed foods captured the baby and toddler market (STAT)
- RFK Jr.’s dangerous misuse of ‘informed consent’ on vaccines (STAT)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
