Recon: BD pledges $19B US investment; McKesson, CD&R to buy Option Care for $5.8B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA delays Novo’s hemophilia A drug review over factory issues (Endpoints) (Fierce Pharma)
- New York declares first US measles disaster emergency since 2025 surge (Reuters)
- Trump says US will help Russia after Siberia plague institute death (Reuters)
- FDA gene therapy office head needs people, technical, regulatory skills, CBER chief says (Pink Sheet)
- AstraZeneca opens new global strategic R&D center in USA (The Pharma Letter)
- Why the FDA should not approve an ineffective multicancer screening test (STAT)
- How Trump’s America First policy hit the Ebola response in Congo (Reuters)
In Focus: International
- No plague cases detected in Siberia, Russia says, and locals play down scare (Reuters)
- More sponsors to qualify as UK expands fast-track pathway for approving phase 1 trials (Pink Sheet)
- Global regulators seek common standards for non-animal drug testing (Pink Sheet)
- Zambia to sign $1.5 billion US health pact after resolving differences over data-sharing (Reuters)
- Forbion gets Lilly's backing in Dutch VC's largest-ever fundraising haul (Endpoints) (Fierce Biotech)
- Indonesia's candidate for WHO chief calls on US to rejoin agency (Reuters)
- Russian govt to speed supplies of foreign innovative orphan and original drugs (The Pharma Letter)
- Shionogi’s Zokovea for COVID-19 among new EU approvals (Pink Sheet)
- Kenya confirms first Ebola case imported from Congo after man dies in Nairobi (Reuters)
- Bangladesh considers dengue vaccine trials as outbreak worsens (Reuters)
Pharma & Biotech
- McKesson, CD&R to buy Option Care in $5.8 billion deal (Bloomberg) (McKesson)
- Shionogi to pay $2B for IntraBio, a commercial rare disease biotech (Endpoints) (BioPharma Dive)
- Ofichem to acquire USA-based Kinentia Biosciences (The Pharma Letter)
- Lilly doubles down on Gate alliance to unlock new drug class with another $870M+ in biobucks (BioSpace) (The Pharma Letter)
- Genentech parts ways with a key AI leader in latest high-profile exit (Endpoints)
- Vaxcyte's pneumococcal vaccine succeeds in phase 3, stock surges (Endpoints) (BioPharma Dive)
- Genmab, AbbVie blood cancer drug combo cuts risk of progression or death in late-stage study (Reuters) (Endpoints)
- Epicrispr reports muscle gains in early FSHD trial (The Pharma Letter)
- Proposed nuclear safety rules threaten to stall Novartis’ Pluvicto expansion (Fierce Pharma)
- ArriVent's cancer pill fails to 'meaningfully' delay disease progression, shares dive (Reuters)
Medtech
- Becton Dickinson pledges $19 billion US investment in deal with government (Reuters)
- UK government unconditionally backs ambitious MHRA AI regulation plans (Medtech Insight) (Reuters)
- UltraSight raises $24 million to expand AI-guided echocardiography to non-specialist ICU staff (Medtech Insight)
Food & Nutrition
- FDA announces plan to address Cyclospora on fresh produce (Food Safety News)
- US among countries to back regional food safety strategy (Food Safety News)
- PepsiCo, Monster, Reliance win reprieve on 'energy drink' label ban in India (Reuters)
Government & Legal
- CDC’s foreign offices begin to shutter (Politico)
- Judges skewer HHS arguments in hearing over Medicare Advantage audits lawsuit (STAT)
- New Trump regulations would clean up health care pricing disclosures (STAT)
- Most Americans support switch to Medicare for all health insurance (Reuters)
- Texas pediatricians face Paxton investigations for vaccinating children (New York Times)
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.
