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February 27, 2025
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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.
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