Recon: AstraZeneca, BMS discuss merger; FDA broadens indication for Novartis’ Pluvicto
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA approves expanded indication for Pluvicto (The Pharma Letter)
- Michigan Supreme Court ruling allows probe into Lilly insulin pricing (STAT)
- Amgen discloses data breach involving patient health information (Reuters)
- UniQure welcomes possible adcomm for Huntington’s asset as regulatory ‘jitters’ spread through biopharma (BioSpace)
- Capricor CEO won’t rule out legal action against FDA after negative adcomm (BioSpace)
- Senate measure would block Trump plan to politicize federal grants, for now (STAT)
In Focus: International
- AstraZeneca, Bristol Myers in talks about merger (FT) (Reuters)
- BioNTech picks Guido Oelkers for new CEO (Fierce Biotech)
- GSK India first-quarter profit rises on steady vaccine demand (Reuters)
- Siemens Healthineers cuts revenue forecast on diagnostics weakness (Reuters)
- Congo's Ebola outbreak started at least in January, report shows (Reuters)
Pharma & Biotech
- Supernus, Indivior to merge and form CNS-focused drugmaker (Endpoints)
- Johnson & Johnson gains exclusive option to acquire Sail Bio (The Pharma Letter)
- Novo cardiovascular drug trial fail deals setback to bid to expand beyond obesity (Reuters)
- Xpovio mulligan in endometrial cancer comes up short as Karyopharm presses on in myelofibrosis (Fierce Pharma)
- Dash Bio nets $30M for 'Amazon Web Services of drug development' (Endpoints)
- Curium deepens radiopharma heft with up to $8 billion deal for Lantheus (Reuters)
- Apnimed raises $192M in IPO for potential 2027 sleep apnea drug launch (Endpoints)
- Ratio Therapeutics raises $70 million for radiopharma pipeline (The Pharma Letter)
- Latigo reports non-opioid pain drug succeeds in key trial (Endpoints)
- Latigo, BlossomHill launch US IPOs as biotech listings rebound (Reuters)
- Moderna delays norovirus vaccine trial readout because of too few infections (Endpoints)
Medtech
- KKR to take medical equipment maker Integer Holdings private in $5.7 billion deal (Reuters)
- Becton Dickinson issues recall on certain lots of needle sets used for emergency IV access (Reuters)
- Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity (BioSpace)
Food & Nutrition
- Cyclosporiasis cases in Michigan rise to 10,773 in ongoing outbreak (Reuters)
- Texas bans products containing synthetic THC forms (Texas Tribune)
- Americans are rethinking their love affair with plant milks (Bloomberg)
Government & Legal
- Drugmakers, retailers must face 'maximum strength' claim in decongestant false ad litigation in US (Reuters)
- Democrats file another lawsuit against Trump’s ACA rule (Modern Healthcare)
- Trump administration revises rebate pilot for 340B drug discount program, angering hospitals (STAT)
- RFK Jr. tells CNN host that constitutional rights take priority over public health (Politico)
- Sandoz agrees $450M settlement with 43 US states over antitrust claims (Reuters)
- In Nebraska, Americans begin to lose Medicaid under Trump's work rules (NPR)
- Congress ended surprise medical bills — doctors and insurers hate it (Politico)
- Medical monitoring and the limits to equity (Drug & Device Law)
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.
