BioSpace News Archive

Orphazyme A/S, a late-stage biopharmaceutical company, announced a restructuring intended to enable the company to advance its corporate strategy and the development of arimoclomol for Niemann-Pick disease type C.

Long-term safety data from a study of adults with moderate-to-severe atopic dermatitis treated with Dupixent will be added to the Dupixent Summary of Product Characteristics following a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Idorsia Ltd announced the initiation of the Phase 3 registration study “SOS-AMI” to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia’s P2Y12 receptor antagonist, in suspected acute myocardial infarction.

Polyphor AG announced that its global Phase III study, FORTRESS, evaluating balixafortide in combination with eribulin for the treatment of patients with HER2 negative, locally recurrent or metastatic breast cancer, did not meet its co-primary endpoint.

Transgene, a biotech company that designs and develops virus-based immunotherapeutics against cancer, announces that the first UK patient has been enrolled in the Phase I clinical trial of TG4050, Transgene’s innovative individualized cancer immunotherapy, currently being evaluated in HPV-negative head and neck cancer patients.

Exelixis, Inc. and Ipsen announced that COSMIC-312, the ongoing phase 3 pivotal trial evaluating cabozantinib in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma, met one of the primary endpoints, demonstrating significant improvement in progression-free survival at the planned primary analysis.

Eurofins Scientific, a global scientific leader in bioanalytical testing, announces that its subsidiary Eurofins Clinical Testing US Holdings, Inc. has entered into an agreement to acquire DNA Diagnostics Center, a leader in consumer genetic testing.

Targovax ASA, announces that Victor Levitsky, Chief Scientific Officer of Targovax, is invited to present at the 4th Annual Next Gen Immuno-Oncology Virtual Congress-US Edition.

In positive topline results from the Phase 2/3 MEDLEY trial, nirsevimab showed a similar safety and tolerability profile compared to palivizumab when administered to preterm infants or those with chronic lung disease or congenital heart disease entering their first respiratory syncytial virus season.3 Safety and tolerability were assessed by the occurrence of all treatment emergent adverse events and treatment emergent serious adverse events.

Orphazyme A/S, a late-stage biopharmaceutical company, announced 24-month interim results of an open-label extension trial, providing efficacy and safety data for its investigational treatment arimoclomol in Niemann-Pick disease type C for up to 36 months.