Oncoinvent opens new facilities

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.

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.

FluMist, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age.

The company receives the Designation from the U.S. FDA for emilimogene sigulactibac for the treatment of skin wounds in SAVI patients.

The European Commission has granted Orphan Medicinal Product Designation (OMPD) to the company’s lead drug candidate CS1 in the rare disease Pulmonary Arterial Hypertension (PAH). “This designation offers significant advantages, including a 10-year market exclusivity period post-authorization and various benefits during the development process, facilitating our efforts to bring CS1 to patients with PAH in […]