Recon: FDA approves drugs for Parkinson’s, bile duct cancer, rare soft tissue disease; Merck, Daiichi scrap application for ADC in lung cancer
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- AbbVie's next-gen dopamine therapy for Parkinson's gets FDA approval (Endpoints) (BioSpace)
- FDA approves Mirum’s drug for ultra-rare soft tissue disease (Endpoints) (Reuters)
- Elevar wins first FDA approval with second-line drug for bile duct cancer (Endpoints)
- Merck expands Welireg's use to broader set of kidney cancer patients (Endpoints)
- When is one trial enough? Drugmakers push FDA for greater clarity on draft guidance (Endpoints) (Pink Sheet)
- BsUFA IV agreement includes push to reduce revenue, cuts product development fees (Pink Sheet)
- Rosa Sherafat takes over FDA gene therapy clinical review office (Pink Sheet)
- Pioneer of China NewCo model sued in US over trade secret misuse, double-dealing (Fierce Biotech)
- At least five candidates vie to become the next WHO leader, as questions over US role loom (STAT)
In Focus: International
- Eli Lilly blasted for ‘promotional and emotive’ language in GLP-1 press release (Fierce Pharma)
- BioNTech to shutter three sites in Germany as no buyers emerge (Reuters)
- Endpoints, study duration: EMA sets out evidence bar for sickle cell, thalassemia drug approvals (Pink Sheet)
- ‘Not a numbers game’: EMA pushes back on FDA’s single pivotal trial default standard (Pink Sheet)
- UK to close regulatory gaps with £20m research push (Pink Sheet)
- Will EU pharma reform package limit appeal of smaller markets in US MFN era? (Pink Sheet)
- Is USTR German pricing probe turning reimbursement policy into a trade issue? (Pink Sheet)
- Japan addresses non-OTC legal gray area, but it’s not as simple as it looks (Pink Sheet)
- Another China biotech warning: Analysis shows China passes US in oncology approvals (Pink Sheet)
- UK set to miss out on off-patent drug savings, lobby group warns (Bloomberg)
Pharma & Biotech
- Merck, Daiichi end plans to seek speedy approval of lung cancer ADC (BioPharma Dive) (BioSpace)
- Merck pens $2.1B deal with China’s SciBrunch to chase KRAS G12D (Fierce Biotech) (Reuters)
- RNAi biotech City Therapeutics files for IPO (Endpoints)
- Tolerance continues thymus-focused deals with $560M pact for Tanabe's clinical-stage IL-33 drug (Fierce Biotech)
- Novo inks $1.3B Nanexa deal to unlock long-acting obesity injectables (Fierce Biotech)
- Indivior ends PAM drug collab with Addex ahead of Supernus merger (Fierce Biotech)
- Mirum's liver infection drug lowers virus levels in late-stage study (Reuters)
- Adicet Bio CAR-T sparks lupus remissions in early trial as ‘new era’ of autoimmune treatment approaches (Fierce Biotech)
- Novo does another small deal, this time with drug delivery biotech Nanexa (Endpoints)
- Licensing deals on generic versions of Roche flu drug aimed at preparing for pandemic (STAT)
Medtech
- Intuitive expands push into cardiac market with CE mark (MedTech Dive)
- New FDA guidance opens a common playbook for surgical robot makers (Medtech Insight)
- Another safety alert for Impella as Abiomed warns of controller failure (Medtech Insight)
- Reboot risk from React Health VOCSN ventilators prompts FDA early alert (Medtech Insight)
- Eli Lilly eyes $100 million Oura stake as smart-ring maker heads for IPO (Medtech Insight)
- Precision Neuroscience raises $250 million in Series D to advance brain-computer interface (Medtech Insight) (MedTech Dive)
- Roche outlines plans to move towards autonomous AI labs (Reuters)
- BD hires Arthur Hu as chief information and digital officer (MedTech Dive)
Food & Nutrition
- FDA warns three Northeast food importers about missing supplier verification programs (Food Safety News)
- Testing finds widespread microplastics, lower heavy metals in baby foods (Food Safety Magazine)
- In Senate hearing, FDA commissioner nominee says lack of resources will challenge GRAS reform (Food Safety Magazine)
- Raids, red labels and junk food curbs: India's food safety crackdown (Reuters)
Government & Legal
- Jury awards Nektar $90M in suit against Lilly (Endpoints)
- Trump administration uses rare authority to claw back nearly $1B in spending approved by Congress (AP News)
- Nothing to see here: FDA issues interchangeable biosimilars strategy document (FDA Law Blog)
- CDC vaccine policy recommendations grind to a halt under health secretary Kennedy (AP News)
- 'Zombified' CDC, hobbled by cuts, struggles to fulfill scientific mission (New York Times)
- RFK Jr.’s use of the National Center for Health Statistics will add confusion to measles deaths count (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.
