Clinical Trials

The EMA's CHMP has backed Foundayo, a once-daily orforglipron tablet, for weight management and type 2 diabetes.

"EMA's draft reflection paper sets out how confirmatory platform trials should handle controls, randomisation, blinding and multiplicity. Comments are due 31 January 2027. #SyenzaNews #MarketAccess #ClinicalTrials"

Researchers and Allegheny County plan a $13.3 million trial of weekly semaglutide to reduce opioid and alcohol use and justice involvement.

The EMA has authorised Denosumab Ascend, a biosimilar of Xgeva. Here is what the assessment shows on safety, efficacy and use. #SyenzaNews #biotechnology #MarketAccess

OHE's A Dose of Economics explores why medicines made for one patient challenge regulation, payment and HTA.

The EU's ACT EU advice pilot for clinical trial applications becomes permanent in January 2027, with updated sponsor guidance.

A University of Minnesota model fine-tuned on routine clinical notes separated epileptic from psychogenic seizures with an AUC of up to 0.875, and helped neurologists lift their own accuracy by up to 14.3 percentage points. #SyenzaNews #epilepsy #AI #digitalhealth #MarketAccess

Novartis has won the first FDA approval for symptomatic dermographism. Rhapsido (remibrutinib) is now cleared for adults whose hives and itch stay uncontrolled on H1 antihistamines, with 29.3% of patients achieving complete hive resolution at Week 12 against 14.0% on placebo. #SyenzaNews #dermatology #MarketAccess

Genmab and AbbVie report topline Phase 3 results in which epcoritamab plus R-CHOP cut the risk of progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma, the first positive readout for a bispecific combination in the first-line setting. #SyenzaNews #DLBCL #bispecifics #oncology #MarketAccess

Vaxcyte's VAX-31 met every prespecified primary endpoint in the OPUS-1 Phase 3 trial in adults, including superiority for the three serotypes unique to the vaccine. The 31-valent candidate now heads toward a BLA filing in 2028. #SyenzaNews #vaccines #pneumococcal #MarketAccess

Jaypirca becomes the first non-covalent BTK inhibitor cleared for previously untreated CLL/SLL in the United States. BRUIN CLL-313 showed a hazard ratio of 0.20 against bendamustine plus rituximab, but the comparator is not the drug class that dominates first-line care. #SyenzaNews #MarketAccess #oncology #CLL

Clinical trials authorised across the EU and EEA fell 13.5% between the pre-pandemic years and 2022 to 2025, and the drop lands hardest on academic sponsors. Biologics now feature in nearly half of all new trials. #SyenzaNews #clinicaltrials #HTA #MarketAccess