FDA to review Bristol-Myers’ Opdivo for classical Hodgkin lymphoma
The agency will review the submission under priority review status which reduces the review time to six months from the standard 10 months. In May 2014, the FDA
Amberstone Biosciences has signed a partnership and licence agreement with Shanghai Henlius Biotech for conditionally activated T-cell engager candidates to treat solid tumours.
These include head and neck, anal, and cervical cancer, as well as anal, vaginal, penile, vulvar and cervical pre-cancerous neoplasias. PDS0101 is based on the company’s proprietary Versamune®
KAR5585 is being developed for the treatment of pulmonary arterial hypertension (PAH) and other rare diseases marked by extensive fibrosis. KAR5585 is a first-in-class, selective inhibitor of tryptophan
All 29 member states included in the decentralized procedures supported approval of the product. The authorities’ approval formally acknowledges that Synthon’s glatiramer acetate is regarded therapeutically equivalent to
The licensing agreement also encompasses rights for all therapeutic indications to cirmtuzumab, an anti-ROR1 monoclonal antibody that is currently in a clinical trial for patients with chronic lymphocytic