Recon: Hikma prevails in Supreme Court 'skinny label' case; UK’s NICE backs AbbVie’s ovarian cancer drug Elahere

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

In Focus: US

• Acting US FDA chief meets with rare disease groups to mend fences (Reuters)
• Trump administration to strip job protections of top NIH officials, grants staff (STAT)
• Supreme Court sides with Hikma in 'skinny label' case (Endpoints)
• FDA Issues Final Guidance for Content of Human Factors Information in Medical Device Submissions (FDA Law Blog)
• GLP-1 drugs may have a beneficial effect across many types of cancer (Reuters)

In Focus: International

• Roche chairman likens US tariff policy to 'blackmail' (Reuters)
• Germany’s health-spending plan has consequences as Lilly, Boehringer scale back (Endpoints)
• British drug-cost watchdog recommends use of AbbVie's ovarian cancer therapy (Reuters)
• US equipment, experts arrive at Kenya Ebola facility despite court order, protests (Reuters)
• Brazil Tightens Surveillance Of GLP-1 Agonists (Pink Sheet)
• EU Pilot Shows 70-Day Multinational Trial Approvals Possible, EFPIA Calls For Consistency (Pink Sheet)

Pharma & Biotech

• ADC Therapeutics plunges after patient deaths in blood cancer drug trial (Reuters)
• Grail’s multi-cancer early detection trial was negative. But as an oncologist, I see more to this story (STAT)
• Alnylam to partner with Inceptive Nucleics for AI foundation models for RNAi therapeutics (STAT)
• HaloMD faces lawsuit alleging No Surprises Act middleman used ‘sham letter,’ misleading data (STAT)
• Does Revolution Medicines’ pancreatic cancer drug have even greater potential? (STAT)
• Parabilis Medicines charts $413M IPO to back peptide pipeline (Endpoints)
• ADC biotech Ona Therapeutics secures $86.6M in Series B raise (Endpoints)
• 'It's still working': More are living with cancer as era of targeted drugs takes hold (Reuters)

Medtech

• Medtronic seeks clearance for Hugo surgical robot in more indications (MedTech Dive)
• Edwards gets FDA approval for surgical tricuspid valve (MedTech Dive)
• Medtronic boosts revenue by nearly double digits in Q4 (MedTech Dive)
• MiniMed expands Abbott partnership to add dual glucose-ketone sensor (MedTech Dive)
• Nuwellis Push To Expand Aquadex Pediatric Use Backed By Real-World Evidence (MedTech Insight)
• Fractyl’s One-Time Procedure Shows Durable Weight Control A Year After GLP-1 Withdrawal (MedTech Insight)
• Abiomed’s Impella Franchise Faces Mounting Safety Questions As FDA Issues Third Alert In Weeks (MedTech Insight)
• Diabetes tech companies are racing toward ‘fully closed loop’ devices. But automation comes with trade-offs. (MedTech Dive)

Food & Nutrition

• Top ultra-processed food researchers call for sweeping policy change: ‘The system is rigged’ (STAT)
• Flesh-eating screwworm confirmed in Texas calf as parasite crosses border from Mexico (Reuters)

Government, Regulatory & Legal

• US senators question Big Tobacco on lobbying related to FDA policy shift (Reuters)
• Online care is caught in the crossfire as states crack down on corporate medicine (STAT)
• Lawmakers promised cancer patients would be protected from Medicaid cuts. Now CMS says otherwise (STAT)
• Atherectomy Overuse In Office-Based Labs Draws Medicare Scrutiny In New Watchdog Report (MedTech Insight)

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.