Industry & Policy News

[Argenx] Argenx announced that Japan’s Ministry of Health, Labour and Welfare approved VYVDURA for adults with chronic inflammatory demyelinating polyneuropathy.

[University of Auckland] Dr. Howe Mao has been awarded a $260,000 Clinical Research Training Fellowship to improve molecular understanding of pancreatic cancer.

[Nuvation Bio] Nuvation Bio announced that China’s National Medical Products Administration has approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not been previously treated with ROS1 tyrosine kinase inhibitors.

[Astellas Pharma] Astellas Pharma announced that China’s NMPA has approved VYLOYTM, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive.

[Amgen (BusinessWire)] Amgen announced that the UK’s Medicines and Healthcare products Regulatory Agency has granted a conditional marketing authorisation to IMDYLLTRA® for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after at least two prior lines of therapy, including platinum-based chemotherapy.

[Capricor Therapeutics] Capricor Therapeutics announced the completion of the submission of its Biologics License Application to the US FDA seeking full approval for deramiocel, an investigational cell therapy, to treat patients diagnosed with Duchenne muscular dystrophy cardiomyopathy.