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Cerevance’s new phase 2 data suggests that its investigational Parkinson’s drug improves function without directly stimulating dopaminergic pathways. Read More
Akebia Therapeutics will have to conduct a new clinical trial if it wants to move its kidney disease drug vadadustat forward, the FDA said in a Complete Response Letter (CRL) denying approval for the investigational drug. Read More
Clovis Oncology’s Rubraca (Rucaparib) nearly halved the risk of disease progression in women with newly diagnosed advanced ovarian cancer following treatment combined with platinum-based chemotherapy. Read More
Roche has said its investigational monoclonal antibody, tiragolumab, combined with Tecentriq (atezolizumab) and chemotherapy did not meet the endpoints of overall survival or progression-free survival in a phase 3 study in patients with extensive-stage small-cell lung cancer (ES-SCLC). Read More
Sanofi and IGM Biosciences have signed an agreement to create, develop, manufacture and commercialize immunoglobulin M (IgM) antibody agonists against three oncology targets and three immunology/inflammation targets. Read More
Three antibodies directed at interleukins — inflammatory proteins associated with a number of skin disorders — posted positive phase 3 results and were touted at the annual meeting of the American Academy of Dermatology (AAD). Read More
The FDA has told MEI Pharma and Kyowa Kirin that they will need to provide more than results from a single-arm phase 2 study on their oral lymphoma drug candidate zandelisib to have it considered for the agency’s accelerated approval pathway. Read More
AstraZeneca’s checkpoint inhibitor Imfinzi (durvalumab) didn’t meet its primary endpoint of improving progression-free survival when compared with chemoradiotherapy (CRT) alone in the treatment of patients with locally advanced cervical cancer, the company said. Read More