Syenza News — health technology assessment, market access and health economics
Medicare drug price negotiation: CMS sets permanent rules
The final rule also covers a temporary price floor for small biotech drugs and Part D plan payments to dispensing entities. #SyenzaNews #DrugPricing #MarketAccess
Recent Posts
Zepbound and Foundayo telehealth access via Hims & Hers
Nov 9
M72 tuberculosis vaccine approval in Indonesia: BPOM weighs a fast track
Nov 6
Refixia Nonacog Beta Pegol: INFARMED Recommends Funding for Children Under 12 With Haemophilia B
Nov 6
Recent Zolgensma safety concerns: what Novartis has reported
Nov 6
Dupilumab Chronic Spontaneous Urticaria: G-BA Finds No Proven Added Benefit
Nov 6Syenza's Top Picks
Orphan Medical Devices Pilot Closes With 13 Positive Status Opinions
Oct 28, 2026
FDA Grants Accelerated Approval to Voceryq for Recurrent Respiratory Papillomatosis
Nov 2, 2026
Migraine Medicines in Portugal: Patients Pay 61% of the Outpatient Bill
Nov 2, 2026
Innovation Growth Theory: Bonvillian on Solow, Romer and Talent
Nov 2, 2026
Labor Department Finalizes PBM Fee Disclosure Rule for Large Self-Insured Plans
Oct 30, 2026
Lancet Authors Make the Case for an EU Medical Device Agency
Oct 30, 2026
Latest News
Artificial Intelligence And Machine Learning Free account
State AI Liability in Health Care: Lawsuits Test Insurers, Apps and Chatbots
A Congressional Research Service sidebar maps the state lawsuits over AI in health care, from insurer claim denials to wellness apps and chatbots.
Europe Free account
EMA Mid-Year Report 2026: Reform, Supply and the First Joint Clinical Assessment
The EMA mid-year report 2026 records 485 scientific advice requests in the first half, the first joint clinical assessment under the HTA Regulation and progress on the new pharmaceutical law. #SyenzaNews #MarketAccess
Clinical Practice
Truqap prostate cancer withdrawal: AstraZeneca pulls EU bid
“Truqap prostate cancer withdrawal: AstraZeneca pulled its EU bid for newly diagnosed use after EMA raised benefit-risk concerns.” #SyenzaNews #MarketAccess
Cardiovascular And Metabolic Diseases
Mayo Clinic’s TV question for the home blood pressure monitor
A Mayo Clinic cardiologist’s TV-set question makes the case for a home blood pressure monitor, with a caution on device reliability and home data in the chart.
Cost Effectiveness Analysis Free account
Second Cochlear Implant Now Covered for Adults in the Netherlands
The Dutch health institute Zorginstituut Nederland has concluded that a second cochlear implant for adults with severe hearing loss in both ears belongs in the basic health package. #SyenzaNews #MarketAccess
Clinical Guidelines And Protocols
Global Drug Regulators Summit in Seoul Takes Up AI and Animal Testing Alternatives
The Ministry of Food and Drug Safety hosts ICMRA, the international coalition of medicines regulators, in Seoul from 3 to 6 November 2026, with AI rules and alternatives to animal testing on the agenda. #SyenzaNews #MarketAccess #drugregulation
Clinical Practice Free account
FDA Potency Assurance Guidance: What It Asks of Cell and Gene Therapy Makers
FDA has finalized its potency assurance guidance for cell and gene therapy products. It covers lot-release testing, potency assays, acceptance criteria and how sponsors should build a strategy from the IND stage onward. #SyenzaNews #CellAndGeneTherapy #FDA
Diseases
Generic lenacapavir HIV prevention gets FDA tentative approval
Dr. Reddy’s has FDA tentative approval for generic lenacapavir HIV prevention, priced at US$40 per person per year across 120 countries. #SyenzaNews #HIVprevention #MarketAccess
Asia Free account
PBS Strategic Agreements: What Government and Industry Told Patients Before the Next Deal
Australia’s PBS strategic agreements with the medicines industry expire on 30 June 2027. At a 23 October webinar, the health department, GBMA and Medicines Australia explained what the deals cover, how patients can feed in, and where industry says they have fallen short on access. #SyenzaNews #MarketAccess #HTA #PBS #Australia
Clinical Practice Free account
EMA Opens Deanxit Safety Review Over Movement and Memory Side Effects
EMA’s safety committee has opened a Deanxit safety review at Belgium’s request, after reports of movement disorders and memory problems with the flupentixol/melitracen combination. The Belgian agency also questioned the benefit of combining the two substances. #SyenzaNews #Pharmacovigilance #EMA #MentalHealth
Value Science Weekly
The week in health technology assessment, market access and health economics — what moved, and what it means.
