Recon: FDA to reduce number of studies needed for most drugs; CDC advisers delay vote on hepatitis B vaccine

• Trump has ‘shaken the hell’ out of the 80-year research pact between the government and universities. What now? (STAT)
• Top Senate health leader calls CDC vaccine panel ‘totally discredited’ (STAT)
• FDA to lower number of trials required for approval of drugs, other medical products (STAT)
• Exclusive: Trump administration pushes end-of-term deadline for ‘most favored nation’ promises (Endpoints)
• Prasad's claim of 10 Covid vaccine deaths may be an overcount, FDA sources say (Endpoints)
• FDA names Tracy Beth Høeg, who helped lead Covid shot investigation, as acting CDER chief (Endpoints)

• In reciprocal licensing pact with Kelun, Crescent's PD-1xVEGF heads to China (Endpoints)
• ARCH, Lilly Asia Ventures return to back US-China startup SciNeuro (Endpoints)
• Novo Nordisk gears up for December Ozempic launch in India, sources say (Reuters)
• US signs pact with Kenya under 'America First' global health plan (Reuters)
• UK MHRA’s Medtech Regulatory Update Must Keep Future EU MDR Changes In Mind (MedTech Insight)

• A single shot of HPV vaccine may be enough to fight cervical cancer, study finds (STAT)
• Paradigm Health, seeking to use AI to enroll clinical trials, partners with Roche (STAT)
• Nationwide Children’s gene therapy shows early promise after Taysha pullback (Endpoints)
• Mark Cuban seeks Trump’s backing for drug fee relief to spur generics manufacturing (Reuters)

• Women can self-test at home for cervical cancer virus, new guidelines say (Reuters)
• Medtronic’s Hugo surgical robot earns FDA clearance (MedTech Dive)
• Medtronic launches insulin delivery system with Abbott-made sensor (MedTech Dive)
• Akura Medical raises $53M to advance thrombectomy portfolio (MedTech Dive)
• PitchBook: AI tuck-in deals to drive M&A acceleration in 2026 (MedTech Dive)
• Medtronic names Jeb Denny as chief medical officer for acute care and monitoring (MedTech Dive)
• Truvian Secures FDA Clearance For Benchtop Blood-Testing System, Eyes Full Launch H2 2026 (MedTech Insight)

• European Union Reaches a Deal to Allow Gene Editing in Farming (Bloomberg)
• The chemistry of comfort: Inside the rise of nostalgic snacks (Food Dive)

• What West Virginia teens lost when CDC cuts ended their fight against Big Tobacco (STAT)
• CDC vaccine advisers appear likely to recommend delaying hepatitis B vaccine birth dose (STAT)
• Daiichi Sankyo avoids payout in long-running patent dispute with Pfizer’s Seagen (Endpoints)
• Obamacare premium spikes could drive off enrollees, most want subsidy extension, KFF finds (Reuters)
• Change To Medicare Diabetes Supply Payments Raises Access And Pricing Concerns (MedTech Insight)
• FDA’s Tobacco Civil Money Penalty Authority, cont’d: Not Backing Down (FDA Law Blog)