IQWiG: No Added Benefit for Darolutamide Over Apalutamide Without Direct Comparative Data
IQWiG has concluded that darolutamide offers no proven added benefit over apalutamide for metastatic hormone-sensitive prostate cancer.
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NICE Expands Cancer and Dermatology Options With Three Major Recommendations Across DLBCL, Myeloma, and Chronic Hand Eczema
NICE has issued three major recommendations expanding access to Columvi-GemOx for DLBCL, talquetamab for relapsed myeloma, and delgocitinib for chronic hand eczema.
Vietnam Targets 2026 Rollout of Free Annual Health Checks and Expanded Insurance Coverage
Doctors providing check-ups with a sign announcing free annual health checks and expanded insurance. Vietnam Sets Ambitious 2026 Plan for Free Annual Health Checks, Expanded Coverage, and System-Wide Reform Vietnam is preparing to deliver one of its most far-reaching public-health reforms in decades, a nationwide guarantee of one free annual health check or screening for … Read more
Biogen’s High-Dose Nusinersen Wins CHMP Backing for Enhanced SMA Treatment
Biogen has earned a positive CHMP opinion for its high-dose nusinersen regimen, supported by strong DEVOTE study results showing major motor improvements and reduced mortality risk in SMA patients.
J&J’s $3B Halda Deal Sets Up $50B Oncology Push
J&J is acquiring Halda Therapeutics for $3.05B, gaining a precision prostate cancer therapy and a breakthrough induced-proximity platform.
Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 10, 2025
The Week’s Biggest Shifts in Payer Strategy This week’s policy and access landscape was defined by a sweeping overhaul of U.S. Medicaid drug pricing and a widening push toward value-driven reimbursement models. CMS’ newly announced GENEROUS model, paired with Most Favored Nation (MFN) pricing agreements for GLP-1s, marks a structural shift that will reshape affordability … Read more
UK VPAG DECISION DEADLINE EXTENDED AGAIN
The UK and ABPI have agreed to a third extension of the VPAG withdrawal deadline, moving it to December 16, 2025.
Cidara Therapeutics Stock sky-Rockets on $9B Merck buyout
Merck’s $9.2 billion acquisition of Cidara brings CD388, a Phase 3 long-acting influenza antiviral, into its pipeline while adding the Cloudbreak® drug-Fc conjugate platform for future oncology and infectious-disease programs.
ICER Releases Draft Scope on COVID-19 Vaccines
The Institute for Clinical and Economic Review (ICER) has posted a draft scoping document outlining its plans to assess the long-term clinical and economic value of updated COVID-19 vaccines.
TLV Endorses Keytruda Combo for Advanced Cervical Cancer with Cost-Effectiveness Caveats
Sweden’s TLV has published its health economic assessment of Merck’s Keytruda for locally advanced cervical cancer, finding clear efficacy benefits when added to chemoradiation. However, the agency warns that cost-effectiveness hinges on price transparency and real-world survival durability.