Recon: Lilly produces billions of weight-loss pills ahead of FDA approval; Philips gets FDA warning letter over issues at 3 facilities
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US Fires Top Health Official Who Opposed Widely Used Covid Shot (Bloomberg)
- Lilly partners with Nvidia on AI supercomputer to speed up drug development (Reuters)
- Lilly Makes Billions of Weight-Loss Pills Before US Approval (Bloomberg)
- CSL Plunges to 7-Year Low After US Vaccine Slump Hits Seqirus (Bloomberg)
- FDA rejects Eylea HD for ongoing manufacturing issues (Fierce Pharma)
- US FDA flags quality issues at three Philips' facilities (Reuters) (Bloomberg)
- US appeals court revives $2.5 billion opioid lawsuit in West Virginia (Reuters)
- Global security is impossible without sufficient support for global health (STAT)
- UK gives drugmakers more time to consider exiting medicine rebate scheme (Endpoints)
- Novartis shares fall as generics dent blockbuster heart drug (Reuters)
- Canada poised to lose measles elimination status, a possible harbinger of more disease outbreaks (Reuters)
- As Novo buyout anniversary nears, CDMO Catalent refines brand to highlight 'missions that matter' (Fierce Pharma)
- Miriam Merad’s 20-year quest to understand one cell is starting to rewrite the rules of cancer immunotherapy (STAT)
- America needs a trusted national patient registry for leucovorin and autism (STAT)
- Psychedelic-like therapy posts encouraging early data, as regulators clear at-home testing (STAT)
- GSK to license Empirico’s COPD candidate for $85M upfront (Endpoints)
- Novartis could sell more drugs through direct-to-patient service (Endpoints)
- Regeneron discloses CRL; AbbVie stops work on Dragonfly asset (Endpoints)
- GHO Capital gets $2.9B for fourth healthcare PE fund (Endpoints)
- Startup launches with $80M and a plan to teach the immune system to make better Tregs (Endpoints)
- Organon CEO exits after internal probe over 'channel stuffing' to boost sales (Endpoints)
- 'Poor children of very rich parents': How Verily plans to grow out of Alphabet's shadow (Endpoints)
- Gerresheimer appoints Uwe Röhrhoff as new interim CEO (Reuters)
- Merck-Eisai's kidney cancer drug combo shows mixed results in late-stage study (Reuters)
- BioMarin resigned to ending journey with hemophilia A gene therapy Roctavian, seeks divestiture amid sales struggle (Fierce Pharma)
- After lupus nephritis nod, Roche keeps Gazyva momentum rolling with phase 3 win in another kidney condition (Fierce Pharma)
- Eli Lilly teams up with basketball legend Shaquille O'Neal to take sleep apnea awareness campaign to new heights (Fierce Pharma)
- Olympus execs talk about import alert, GI robot and AI (MedTech Dive)
- Medtronic links renal denervation to 3-year blood pressure reduction (MedTech Dive)
- Health systems are racing to adopt AI. But can they prove its value? (MedTech Dive)
- When SNAP benefits run out, ‘people can die,’ say health experts (STAT)
- Meat costs continue to surge (Food Dive)
- Blue Cross plans to target doctors for overcharging. Physicians are furious (STAT)
- Cigna says it will move to end drug rebates beginning in 2027 (Endpoints)
- UnitedHealth Sees 2026 Growth as It Navigates Historic Meltdown (Bloomberg)
- Texas sues Tylenol makers J&J and Kenvue, claiming they hid drug's autism risks (Reuters)
- Onshoring Drug Manufacturing: Insights from FDA’s PreCheck Initiative and Public Meeting (FDA Law Blog)
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