In a stunning turn for its oncology drug, rociletinib (CO-1686), Clovis Oncology Inc. reported that the FDA wants additional clinical data to evaluate the efficacy of the 500 mg and 625 mg dose groups in the treatment of NSCLC patients with initial activating epidermal growth factor receptor mutations, as well as the dominant resistance mutation T790M. Read More
Almost four months ahead of the FDA Prescription Drug User Fee Act (PDUFA) goal date of March 9, 2016, the agency granted accelerated approval to Genmab A/S's anti-CD38 multiple myeloma antibody Darzalex (daratumumab) injection, administered as a single agent for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an IMiD agent. Read More
LONDON – World Health Organization (WHO) director general Margaret Chan has launched a global campaign to preserve the effectiveness of existing antibiotics by limiting their use and acknowledged the need for accompanying measures to create commercial incentives for pharmaceutical companies to develop new products. Read More
DUBLIN – Pierre Fabre SA is paying Array Biopharma Inc. $30 million up front plus up to $425 million more in milestones for European, Asian and Latin American rights to its phase III Mek inhibitor binimetinib and its phase III BRAF inhibitor encorafenib, thereby cleaning up the fallout from Novartis AG's purchase of Glaxosmithkline plc's oncology business. Read More
Baxalta Inc. expanded its hemophilia franchise with FDA approval of Adynovate (antihemophilic factor [recombinant], pegylated) to treat hemophilia A. The therapy, which was built around the company's existing treatment, Advate (octocog alfa, or antihemophilic factor [recombinant]), with pegylation technology from Nektar Therapeutics Inc., extends treatment times to twice-weekly dosing, compared to conventional therapy of three to four doses per week. Read More
Treatment with an antibody that is the mouse equivalent of bapineuzumab (Janssen Pharmaceuticals Inc. / Pfizer Inc.) not only failed to reduce the neuronal hyperactivity that is a physiological feature of Alzheimer's disease (AD), but actually worsened it. Read More
SAN FRANCISCO – New clinical data from Gilead Sciences Inc. and Bristol-Myers Squibb Co., presented at the American Association for the Study of Liver Diseases Annual Meeting added support to the drugmakers' cases for the efficacy of therapeutic combinations capable of battling HCV, especially among those patient with hard-to-treat cases. Read More
SAN FRANCISCO – Drugmakers targeting nonalcoholic steatohepatitis (NASH) unleashed a torrent of new data and plans at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in San Francisco over the weekend, including updates on late-stage studies and news of early progress on efforts to minimize reliance on invasive liver biopsies to identify patients with the disease. Read More
Titan Pharmaceuticals Inc., of South San Francisco, said it has added Proneura T3, an implantable triiodothyronine (T3) product for the treatment of hypothyroidism to its product development pipeline. Read More
Cellceutix Corp., of Beverly, Mass., said that, based upon ongoing laboratory studies, it intends to use docetaxel for the combination therapy arm in a planned phase II trial to treat patients with platinum-resistance ovarian cancer. Read More
Mina Therapeutics, of London, presented preclinical data on its MTL-CEBPA program in which the compound was shown to improve several markers of liver function in a rat model of liver failure. MTL-CEBPA is the first development candidate to emerge from Mina's RNA activation platform and the company is advancing the compound into clinical investigation in 2016 with an initial focus on patients with liver cancer and impaired liver function. Read More
