Risk-based quality management (RBQM) and data quality oversight software company Cluepoints launches its latest application, the medical & safety review (MSR), to simplify and streamline the medical analysis of study data through user-friendly dashboards, data manipulation and cleaning, query management and full transparency over the data history.

Johnson & Johnson Innovative Medicine (formerly Janssen) has announced the long-term phase 3 results from its cartitude-4 study, which evaluated treatment CARVYTKI in patients with relapsed or lenalidomiderefractory multiple myeloma after one prior line of therapy.

Etranacogene dezaparvovec (hemgenix), the first gene therapy approved in Europe for the treatment of severe and moderately severe haemophilia B in adult patients, has been approved for national reimbursement by the Spanish Interministerial Pricing Commission for Pharmaceuticals (CIPM).

Ars pharmaceuticals has been granted approval by the us food and drug administration (fda) for their epinephrine nasal spray, neffy, to be used as treatment of type 1 allergic reactions including anaphylaxis.

Accelerated approval has been granted for Gilead science’s livdelzi (seladelpar) to treat primary biliary cholangitis (pbc) by the US Food and Drug Administration (FDA).

Accord healthcare have recently announced that NICE have recommended the first oral androgen deprivation therapy (adt) treatment for hormone-sensitive prostate cancer. Prostate cancer is the most common cancer in men across the uk.

This month, Verisense have announced that their digital biobank, with data from over one million people, is open for business.

Biotechnology company Levicept has announced positive results from its phase 2 trial into levi-04 for the treatment of osteoarthritis.

Calliditas therapeutics ab has recently announced that the phase 2b transform trial met its primary endpoint. The trial showed statistically significant improvement in alkaline phosphatase (alp) for both doses tested versus placebo. the trial evaluated setanaxib, a nox enzyme inhibitor, in patients with primary biliary cholangitis (pbc) and elevated liver stiffness.

Merck (known as MSDoutside of the US and Canada) has announced that its anti-pd-1 therapy, in combination with padcev (enfortuman vedotin-ejfv), has received a positive opinion from the European Medicines Agency (EMA)

Researchers at the UCLA Health jonsson comprehensive cancer center have announced that they are launching a first-of-its-kind clinical trial to evaluate the safety and effectiveness of a cancer vaccine. The vaccine targets h3 g34-mutant diffuse hemispheric glioma, an aggressive brain tumour typically found in adolescents and young people.

The National Institute for Health and Care excellence (NICE) have recommended adult patients in England or Wales with moderately or severely active ulcerative colitis (uc) who have not responded well to or cannot tolerate conventional or biological therapy including a tumour necrosis factor (tnf) alpha inhibitor the option of skyrizi (risankizumab).