2+ day, 16+ hour ago   (489+ words) AbbVie's Qulipta has become the first oral CGRP inhibitor to show efficacy in a phase 3 study involving women with menstrual migraine, which is severe and tends to resist current treatments. Qulipta (atogepant) has already become a blockbuster treatment after being…...

4+ day, 9+ hour ago   (548+ words) Michael Davis and Karim Mikhail. HHS has moved to firm up the leadership at the FDA after a long period of uncertainty and disruption, upgrading the heads of the agency's centres governing drugs and biologics from acting to permanent status....

4+ day, 10+ 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…...

5+ day, 5+ hour ago   (195+ words) With 18+ data-led presentations on complement-based modalities including siRNA, gene therapies, novel biologics and small molecules, this 10th Anniversary forum will share the latest breakthroughs and strategies within complement science, enabling you to progress your own therapeutic pipeline with confidence. Take a…...

6+ day, 8+ 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…...

6+ day, 10+ hour ago   (536+ words) An NHS trust in the UK has become the first site in Europe to offer Roche's experimental drug trontinemab to patients enrolled in a large-scale trial to see if it can delay or prevent Alzheimer's disease. The phase 3 PrevenTRON study…...

1+ week, 3+ 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…...

1+ week, 4+ day ago   (496+ words) PMV Pharma is preparing to file for approval of its oral p53 protein reactivator drug rezatopopt in the first quarter of 2027, after reporting positive results in a phase 2 trial in ovarian cancer. That schedule means Princeton, New Jersey-based PMV has a…...

1+ week, 4+ day ago   (499+ words) The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has followed through on plans to roll out regional 'sandboxes' for NHS innovations, to operate alongside its centralised initiatives, via a partnership with Manchester University NHS Foundation Trust (MFT). MHRA's first…...

1+ week, 4+ day ago   (474+ words) Over the past decade, immuno-oncology proved a crucial point: given the right direction, the human immune system can recognise and destroy cancer cells. Therapies like checkpoint inhibitors and first-generation CAR-T cells transformed how we think about treatment. But as these…...