Celltrion Inc. and Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin (trastuzumab).
Generon Presents Positive Phase III Results Of F-627 In Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Generon BioMed Holding Ltd. announced at the annual San Antonio Breast Cancer Symposium (SABCS) positive results from a placebo-controlled trial with F-627, a recombinant human Granulocyte Colony Stimulating Factor protein, designed using Generon’s Dikine technology platform.
Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending an expanded indication for Kisqali (ribociclib), the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent, superior and sustained efficacy compared to endocrine therapy alone.
Roche’s Tecentriq will get a speedy review by U.S. regulators in a tough-to-treat form of breast cancer, seeking to be the first company to have an immunotherapy win approval in this indication.
In the wake of a Complete Response Letter issued by the U.S. FDA, Trevana Inc. is slashing one-third of the company’s workforce. Merrimack Pharmaceuticals Inc. is undertaking a corporate restructuring that included the reduction of 60 percent workforce.
An immunotherapy cocktail from Roche helped slow an aggressive type of breast cancer where new treatments have proven elusive.
The U.S. Food and Drug Administration approved Pfizer Inc.’s Talzenna (talazoparib) for an advanced form of breast cancer.
Mersana Therapeutics Inc. announced that the U.S. Food and Drug Administration lifted the partial clinical hold on the Phase 1 study of the experimental cancer drug XMT-1522.
Novartis’ efforts to tackle an elusive gene mutation behind tough-to-treat breast cancer were rewarded as the Swiss drugmaker said one of its investigational medicines slowed disease progression.