Recon: FDA approves Protagonist and Takeda’s drug for rare blood cancer; Lilly to buy Merida for up to $2.88B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA approves Takeda, Protagonist drug as first treatment for rare blood disorder (Endpoints) (STAT)
- FDA approves Lilly's Mounjaro to reduce cardiovascular risk (Reuters) (Lilly)
- FDA approves Roivant therapy for rare autoimmune disease (STAT)
- FDA green lights Priovant drug for rare skin disease (BioPharma Dive) (FDA)
- On the 'cusp,' PharmaEssentia gains FDA label expansion for Besremi (Fierce Pharma)
- FDA scraps program that paid bonuses for completing speedy drug reviews (Pink Sheet)
- FDA grants CorTec second breakthrough device designation for brain-computer interface (Medtech Insight)
- As quantitative medicine initiative grows, FDA wants help maintaining stakeholder interest (Pink Sheet)
- Rare disease, trial modeling pilots will ‘graduate,’ expand in PDUFA VIII (Pink Sheet)
In Focus: International
- BioXcel files for bankruptcy, will sell assets to Teva for up to $125M (BioSpace)
- MHRA directs NHS to review cobalt-chrome modular-neck hip implants from five makers (Medtech Insight)
- Abbott wins CE mark for new LAA closure device (MedTech Dive)
- Global-first approval recommendations in Japan for gefurulimab, anselamimab (Pink Sheet)
- Booming weight-loss drug demand in Brazil fuels thriving black market and health fears (Reuters)
- China poses increasing security risk as US biotech innovation edge erodes (BioSpace)
Pharma & Biotech
- Lilly to buy Merida Biosciences for up to $2.88 billion in autoimmune drug push (Reuters) (Bloomberg)
- Samsung Biologics to launch takeover bid for PolyPeptide in September (Reuters)
- Daiichi Sankyo to give commercial team a makeover; Novo Nordisk's GPCR partner finds CMO (Endpoints)
- Novartis pushes ahead with its IL-6 inhibitor despite Novo's failure (Endpoints)
- AstraZeneca's relaxin pill shows promise in mid-stage heart failure trial (Endpoints)
- BioNTech, Genentech terminate Phase 2 of personalized mRNA cancer vaccine (Endpoints)
- CRISPR Therapeutics to pursue highest dose of its lipid lowering gene editing therapy (Endpoints)
- Roche bets $1B+ on DualityBio's ADC tech to tackle payload resistance (Endpoints)
- Cytokinetics details trial win for what could be its next approval (STAT) (Endpoints)
- Future of AstraZeneca’s gene silencer in heart disease uncertain after trial failure (Endpoints) (STAT)
Medtech
- J&J’s latest Impella recall tied to 3 deaths, 37 injuries (MedTech Dive) (Medtech Insight)
- Medtronic recalls pH monitoring capsule linked to 184 serious injuries (MedTech Dive)
- Epitel, Prapela are first to win READI-Home spots as FDA eyes home-care devices (Medtech Insight)
- Diagnosing more, for less: The promise of ‘near-perfect’ long-read genomics (Medtech Insight)
- More LifeVest PMA preemption (Drug & Device Law)
Food & Nutrition
- US officials tie cyclospora outbreak involving iceberg lettuce to 3 more states (AP News)
- Abbott targets wary parents with liquid whole milk formula (Bloomberg)
- USDA cyclospora research projects shelved amid funding cuts and relocations (Politico) (Reuters)
Government & Legal
- A couple months in, impacts of US government's GLP-1 pilot program take shape (Endpoints)
- Vaccines take center stage at federal autism advisory committee (STAT)
- Pharma's legal battle over Medicare negotiations reaches 'dead end' (Endpoints)
- We quit the CDC last year. The problems we protested remain (STAT)
- RFK Jr.’s health department leads Trump’s push to add politicals to the federal workforce (Politico)
- Sydnexis takes critique of SYD-101 complete response letter to FDA chief counsel (Pink Sheet)
- Making the case for Medicare coverage: Lilly study finds Zepbound looks cost effective (Pink Sheet)
- Pharma industry stares down biggest patent cliff in decades (Wall Street Journal)
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.
