Recon: FDA names new acting CDER, CBER heads; Supreme Court denies pharma’s challenge to IRA price negotiations

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• Supreme Court rejects challenge to Medicare drug price negotiation (STAT)
• Trump to announce discount drug pricing expansion, White House official says (Reuters)
• US Supreme Court turns away Eli Lilly's challenge to whistleblower law (Reuters)
• FDA leadership shakeup widens following Makary’s departure (STAT)
• US health department withdraws vaccine advisory panel charter (Reuters)
• How to restore credibility to the CDC’s vaccine advisory committee (STAT)
• One Day at a Time: FDA’s New AI-Informed Inspection Pilot and What It Means for Industry (FDA Law Blog)

In Focus: International

• The China question is tearing biotech apart (STAT)
• Sanofi says rare lung disease drug outperforms standard care in trial (Reuters)
• UK advocacy groups threaten court action over a key provision in the pharma trade deal with the US (STAT)
• The hantavirus outbreak is prompting Covid flashbacks — including the conspiracies (STAT)
• Britain gets experimental drug from Japan to bolster hantavirus response (Reuters)
• In Ebola outbreak, a number of Americans in the Congo believed to have had exposure to suspected cases (STAT)
• Health workers race to contain Congo's fast-spreading Ebola outbreak (Reuters)
• Roche, Medicines Patent Pool sign deal to expand access to influenza drug (Reuters)

Pharma & Biotech

• Merck's drug helps uterine cancer patients live longer in late-stage trial (Reuters)
• After key trial fail, Regeneron reaches $125M Parabilis deal for hard-to-catch drug targets (Endpoints)
• AstraZeneca's blood pressure pill approved, but competition could be around the corner (Endpoints)
• Bristol Myers looks at Houston for potential $1B manufacturing plant (Fierce Pharma)

Medtech

• Boston Scientific buys $1.5B stake in TAVR developer MiRus (MedTech Dive)
• Natera wins FDA approval for companion diagnostic (MedTech Dive)
• Embecta closes Owen Mumford acquisition for up to $201M (MedTech Dive)
• Dexcom to add 2 board directors with activist investor Elliott (MedTech Dive)
• Carl Zeiss says restructuring could affect up to 1,000 jobs (MedTech Dive)

Food & Nutrition

• FDA names safety vet acting head of food (Food Dive)
• Grocery inflation hits highest level since mid-2023 (Food Dive)

Government, Regulatory & Legal

• US states reject anti-vaccine bills as public health groups fight MAHA (Reuters)
• Adult dies of hantavirus in Colorado, state health officials say (Reuters)
• Trump's psychedelic drug order boosts investor interest with promise of faster reviews (Reuters)
• UnitedHealth falls after Berkshire sells stake in health insurer (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.