Specialist Payment Models: Triple the Cardiac Testing, No Difference in Outcomes

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have opened a public consultation on a draft EMRN data standards framework, the governance document that will shape how the European medicines regulatory network adopts, creates, updates, and implements data standards for human and veterinary medicines. The draft, published under reference EMA/185661/2026 and dated 1 July 2026, is open for comment from 17 August to 18 September 2026. Responses go through an EUSurvey form linked in the consultation […]

Hanmi Pharm has signed a licensing deal with Genentech for its novel obesity candidate HM17321, worth up to $2.3 billion. The UCN2 analog is designed to cut weight while preserving lean muscle mass, a gap GLP-1 therapies have not filled. #SyenzaNews #biotechnology #drugdevelopment #MarketAccess

Weill Cornell researchers have proposed ASTRA, a multi-agent system that would delegate routine clinical trial work to AI agents while human experts keep the final say on clinical and regulatory decisions.

The European Commission has approved Trodelvy plus Keytruda for first-line metastatic triple-negative breast cancer, making Trodelvy the first ADC-based backbone across PD-L1 status.

A new consensus framework grades dehiscence, infection, seroma, and haematoma in a single score, with strong agreement across 60 specialists.

Portugal medicinal cannabis exports reached 66,305 kg in the first half of 2026, according to INFARMED, already 83% of the 79,883 kg shipped across all of 2025. The country’s medicines regulator published the figures in its mid-year report on the sector, which also shows cultivation and manufacturing licences easing back after several years of rapid expansion. Portugal began regulating medicinal cannabis in 2018, when the Assembly of the Republic approved a law covering marketing authorisations, prescribing and pharmacy dispensing. A […]

💊 Can generic medicines deliver €300 million in savings for Portugal?

Portugal is targeting major cost reductions in its healthcare system by accelerating the uptake of generic medicines, aiming to improve affordability and sustainability. This move highlights strategic efforts in market access and cost-effectiveness within the pharmaceutical sector.

Read the full analysis to see what it means for stakeholders.
#SyenzaNews #pharmaceuticals #MarketAccess #costeffectiveness

Merck and Moderna’s individualized neoantigen therapy intismeran has cleared its first Phase 3, beating KEYTRUDA alone in resected high-risk melanoma. The open question now is how payers value a medicine made for one patient at a time.

🔑 How is South Africa’s SEP adjustment safeguarding pharma supply security?

The latest Single Exit Price adjustment seeks to balance affordability with manufacturer sustainability, helping to stabilise medicine availability amid economic pressures.

Read the full analysis to see what it means for pricing, supply chains and market access.

#SyenzaNews #pharmaceuticals #regulatoryaffairs #MarketAccess #healthcarepolicy

The FDA has opened a public consultation on regulating generative AI medical devices, proposing a two-axis risk framework and a competency-based approach to premarket review. Comments close 19 October 2026.