2+ day, 22+ hour ago   (562+ words) Bayer has won FDA approval for oral HER2 inhibitor Hyrnuo as a first-line treatment for advanced HER2-mutant non-small cell lung cancer (NSCLC), just a year after it was cleared as a second-line option. Hyrnuo (sevabertinib) has been cleared for earlier use…...

3+ day, 20+ hour ago   (548+ words) BMS CAR-T scientists at work. Bristol Myers Squibb's GPRC5D-directed CAR-T therapy, arlocabtagene autoleucel (arlo-cel), has shown activity in a phase 2 trial that could underpin future filings for blood cancer multiple myeloma. The pivotal QUINTESSENTIAL trial of the potentially first-in-class CAR-T…...

3+ day, 19+ hour ago   (427+ words) Amgen's fast-growing cancer immunotherapy Imdelltra could move into the first-line setting in small cell lung cancer (SCLC), after delivering as a dual regimen with AstraZeneca's Imfinzi in the DeLLphi-305 study. The trial compared the combination as a first-line maintenance therapy…...

3+ day, 21+ hour ago   (616+ words) The FDA has started a priority review of AstraZeneca's IL-33-targeting antibody tozorakimab for chronic obstructive pulmonary disease (COPD), setting up a decision on the would-be blockbuster in the first quarter of 2027. It's an indicator of AZ's excitement about tozorakimab that…...

3+ day, 23+ hour ago   (565+ words) An AI-powered imaging tool developed by Brainomix has been used to enrich data from a phase 2a trial of Endeavor BioMedicines' hedgehog pathway inhibitor taladegib, in development for idiopathic pulmonary fibrosis (IPF). The post hoc analysis of the study showed that…...

4+ day, 19+ hour ago   (552+ words) Swiss biotech Pharvaris has reported positive data from a phase 3 trial of its drug for hereditary angioedema (HAE), setting up marketing applications next year. The drug – an extended-release formulation of bradykinin B2 receptor antagonist deucrictibant – achieved an 83% reduction compared to placebo…...

4+ day, 22+ hour ago   (809+ words) Drug development is an inherently risky endeavour, with the average probability of approval for a drug entering Phase I studies now sitting at just 6.7%. While much of this can be attributed to lack of efficacy, factors such as poor clinical…...

5+ day, 21+ hour ago   (603+ words) The EU Health Technology Assessment (HTA) Regulation became applicable on 12th January 2025, marking a fundamental shift in how clinical evidence for new health technologies is assessed across Europe. Until recently, however, much of the discussion around the JCA has focused on…...

5+ day, 20+ hour ago   (399+ words) Novo Nordisk has opted to discontinue two late-stage trials of IL-6 inhibitor ziltivekimab in heart failure, after an interim look at the data suggested they would be unlikely to show a positive result. The revelation – first reported by Endpoints – affects the…...

1+ week, 2+ day ago   (446+ words) Akeso and Summit's PD-1xVEGF drug ivonescimab has improved overall survival (OS) in another phase 3 trial, this time when used as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC). The results come from the HARMONi-2 trial carried out…...