Recon: FDA upheaval prompts some biotechs to move early trials abroad; AZ’s Imfinzi combo boosts bladder cancer survival in late-stage trial

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

In Focus: US

What the Trump administration wants in its next FDA leader (STAT)
Makary exit may temporarily lift biotech sentiment but FDA leadership vacuum looms (Reuters)
Post-Hoc: What brought down the FDA commissioner (Endpoints)
Biogen to advance experimental Alzheimer's drug despite mid-stage trial miss (Reuters)
What Does Declining Average Commissioner Term Length Say About US FDA’s Future? (Pink Sheet)
PhRMA CEO Backs Parts Of Makary’s US FDA Agenda As Diamantas’ Onboarding Continues (Pink Sheet)

In Focus: International

Tests in Italy, Spain come back negative in global hunt for hantavirus (Reuters)
Bain-backed Tanabe Pharma targets three new drug launches a year in Japan (Reuters)
Upheaval at FDA pushes some biotech firms to move early trials out of US (Reuters)
The curious absence of pharma CEOs on Trump’s China trip (Reuters)
Merck KGaA's clients are stockpiling due to Iran war, supporting guidance boost (Endpoints)
EU Member States To Gain Power to Mandate Medicine Supply From December 2027 (Pink Sheet)

Pharma & Biotech

Regenxbio's Duchenne study succeeded. Will it be enough to convince the FDA? (Endpoints)
EyePoint's late-stage eye drug trials to continue after safety panel review (Reuters)
US cancer clinics scramble to get experimental Revolution Medicines pancreatic cancer drug (Reuters)
AstraZeneca's Imfinzi with pre-surgery drug boosts survival in bladder cancer trial (Reuters)
Takeda's $1.3B savings drive to impact 4,500 roles in '26 (Fierce Pharma)
BeOne's Venclexta challenger Beqalzi nets FDA approval as first BCL-2 for mantle cell lymphoma (Fierce Pharma)
Merck KGaA looks to M&A to bolster its 'rather slim' pipeline (Fierce Pharma)
Novo, Lilly tout respective early response and weight loss maintenance data as GLP-1 rivalry intensifies (Fierce Pharma)
After an apparent cure, a gene editing company struggles to repeat the magic (Endpoints)
Valneva to cut up to 15% of jobs as reduced travel hits vaccine demand (Endpoints)
Behind Galapagos’ transformation into Lakefront Biotherapeutics (Endpoints)
Tessera says infusion edits 85% of blood cells, pointing to off-the-shelf sickle cell fix (Endpoints)
How Patient Urgency Drove 25+ Companies Into Rett Syndrome Drug Development (Pink Sheet)

Medtech

4 medtech manufacturers recall kits over problem with Medline syringes (MedTech Dive)
J&J launches improved Shockwave catheter (MedTech Dive)
FDA Issues Final Guidance For Patient-Matched Orthopedic Surgical Guides (MedTech Insight)
AstraZeneca Joins Pharma’s Agentic AI Race With Three-Year Owkin Deal (MedTech Insight)

Food & Nutrition

Sara Lee owner to invest $1B in US business (Food Dive)
Cantaloupe outbreak declared over (Food Safety News)

Government, Regulatory & Legal

Officials say $1.3 billion in Medicaid money to California will be deferred over suspicions of fraud (STAT)
Hantavirus risk remains low, CDC says, citing its ‘playbook’ response (STAT)
The hantavirus is a wake-up call. Will the Trump administration answer it? (STAT)
CVS unit Omnicare wins court approval for $250 million sale to GenieRx (Reuters)
Using AI in addiction medicine could be particularly risky (STAT)
Easing medical costs a positive for health insurers, but real test lies ahead, analysts say (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.