2+ day, 20+ hour ago   (545+ words) There's been a lot of talk about forging closer ties between Europe and Canada in response to the US' aggressive disruption of international trade. Now, two senior figures in Canada's life sciences sector have said they see scope for greater…...

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, 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…...

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…...

5+ day, 22+ hour ago   (526+ words) The FDA has gone against the advice of its own expert advisors and approved AstraZeneca's Etcamah as a frontline treatment for breast cancer. Oral selective oestrogen receptor degrader (SERD) Etcamah (camizestrant) has been cleared in the US for use in…...

1+ week, 3+ 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…...

2+ week, 5+ day ago   (227+ words) As clinical trials become more complex, sponsors face growing pressure to reach more representative patient populations while reducing participation burden and keeping studies moving without adding strain to sites. In the third episode of our PSCS leadership discussion series, developed…...

2+ week, 5+ day ago   (354+ words) Roche’s Genentech has agreed a deal worth up to $2.3 billion to develop and sell Hanmi Pharmaceutical’s experimental obesity drug HM17321, as the US-based drugmaker looks to explore treatments that can preserve muscle alongside weight loss. Genentech will pay Hanmi $190 million upfront…...

2+ week, 5+ day ago   (371+ words) GSK has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Hibsago (bepirovirsen), an antisense oligonucleotide (ASO), as a functional cure in chronic hepatitis B (CHB) virus infection in adult patients who have received at least six…...