Nordic Pharmacovigilance Day

AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting based on the positive results from the DESTINY-Breast06 Phase III trial which compared Enhertu to chemotherapy.

The Board of Directors of Spago Nanomedical has decided that the company's resources will be focused on the development of Tumorad with the company's primary priority being the execution of the ongoing clinical study Tumorad-01 with the candidate drug 177Lu-SN201.

The board of directors of Senzime has resolved on a directed share issue of a maximum of 13 873 000 shares at the subscription price of SEK 6.20 per share.

Vicore Pharma Holding has announced an investment from Sanofi in Vicore through a commitment to subscribe for shares in the ongoing rights issue corresponding to a total of approximately USD 10 million.

Jay Detsky, radiation oncologist at Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, has presented initial cancer control outcomes from the UNITED trial (Unity-Based MR-Linac Guided Adaptive Radiotherapy for High Grade Glioma).

Cereno Scientific has signed an agreement with medical technology company Fluidda on Respiratory Imaging solutions, with the aim to visualize signs of reverse remodeling of lead drug candidate CS1 in Pulmonary Arterial Hypertension (PAH) in a clinical setting.