Recon: Lilly to broaden expanded access for unapproved obesity drug; Jazz to withdraw second-line SCLC indication for Zepzelca
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Eli Lilly to allow more patients to apply for special access to unapproved obesity drug (STAT)
- Jazz to withdraw Zepzelca with FDA in second-line small cell lung cancer (Fierce Pharma)
- Merck's anti-TL1A antibody scores a win in hidradenitis suppurativa, fails in a rare lung disease (Endpoints)
- Medicare eliminates key pathways used by ‘breakthrough’ devices for extra payments (STAT)
- The latest orphan drug exemptions may not be warranted, analysis finds (STAT)
- California Supreme Court sides with Gilead in ‘duty’ to innovate case (STAT)
In Focus: International
- Moderna begins first human trial of Bundibugyo Ebola vaccine (Reuters)
- Treatment trials for Ebola strain behind Congo outbreak show promise, WHO says (Reuters)
- India pharma sector to miss 2030 sales target amid tariff and shipping woes, trade body says (Reuters)
- Gerresheimer sheds pair of pharma packaging units in deal valued at €1.5B (Fierce Pharma)
- Bayer eyes German launch of stroke drug despite spending cuts in the country (Endpoints)
Pharma & Biotech
- Pfizer beats earnings estimates, targets $2.5 billion in additional cost cuts (Reuters)
- J&J pharma leader to retire (BioPharma Dive) (J&J)
- US officials want to counter China’s pharma rise, but pricing policies may be doing the opposite (Pink Sheet)
- Work ethic becomes a flashpoint as China's biotech pace quickens (Endpoints)
- Merck's anti-TL1A antibody scores a win in hidradenitis suppurativa, fails in a rare lung disease (Endpoints)
- Pathos AI to license experimental breast cancer drug from China's Jiangsu Alphamab Biopharmaceutical (Reuters)
- Merck posts better-than-expected second-quarter results on Keytruda strength (Reuters)
- Otsuka’s Voyxact stabilizes IgAN patients’ kidney function decline to normal levels (Fierce Pharma)
- Rhythm's drug shows promise for brain tumor-related weight condition in small study (Reuters)
- Vertex unfazed by competitive IgAN space as FDA verdict looms (BioSpace)
- Alnylam plunges as earnings deliver ‘one-two punch’ (BioPharma Dive)
- Pathos AI signs two deals, plans to raise Series E at $3B valuation (Endpoints)
- Eli Lilly ripe for stock split after obesity drug-fueled rally (Bloomberg)
- Pfizer raises sales guidance on high demand for older drugs (Bloomberg)
Medtech
- Revvity raises annual profit, revenue forecasts on strong diagnostics demand (Reuters)
- Henry Schein removes 3 longtime execs in leadership shakeup (MedTech Dive)
- Smith & Nephew sales growth to slow on knee implant demand (Bloomberg)
- Akido is expanding AI for patient intake and diagnoses across 100 clinics (Endpoints)
- Siemens Healthineers names new head of the Americas (MedTech Dive)
- I’m using not-FDA-approved software to manage my diabetes. I’ve never felt better (STAT)
Food & Nutrition
- Michigan reports first US deaths in cyclosporiasis outbreak (Reuters)
- Afghan child malnutrition surges as aid cuts force clinics to turn families away, WFP says (Reuters)
Government & Legal
- Medicare finalizes 2.3% hospital inpatient pay raise for 2027 (MedTech Dive)
- A single US measles outbreak can cost millions of dollars, study estimates (Reuters)
- RFK Jr. interview sparks corrections on vaccines, pandemics and measles (Endpoints)
- As Trump administration pushes court-ordered mental health care, a new report raises questions (STAT)
- Kennedy and Oz call Medicaid cuts ‘myths.’ It’s more complicated than that (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.
