Crenezumab, an anti-amyloid β (Abeta) antibody which Genentech in-licensed from AC Immune SA, failed to reach the primary endpoint of two phase II studies in Alzheimer's disease, but the drug has demonstrated tantalizing signs of efficacy in patients at the milder end of the Alzheimer's spectrum. Read More
Following Astrazeneca plc's decision to return fostamatinib rights to Rigel Pharmaceuticals Inc. last year, Rigel is pushing ahead with twin phase III studies of the oral spleen tyrosine kinase (SYK) inhibitor in patients with the tough-to-beat bleeding disorder, immune thrombocytopenic purpura (ITP). Read More
SHANGHAI – HD Biosciences Co. Ltd. has signed an agreement to co-develop drugs with two research centers at Marshall University. The deal was struck after three years of informal collaboration between both sides, and with an eye to entering the clinic in the next two years. The focus of the alliance is to provide innovative medicines for unmet medical needs, particularly cancer and kidney fibrosis, in both China and the U.S. Read More
LONDON – The deals go on for Immunocore Ltd., which has signed Eli Lilly and Co. as the fourth partner in little over a year for its Immtac T-cell receptor technology. Read More
Researcher John Lambris has devoted his career of more than 30 years to exploring the human complement system. His lab at the University of Pennsylvania, where Lambris serves as professor of research medicine in the department of pathology and laboratory medicine, was among the first in the world to map the critical sites on the human C3 protein that are responsible for its many functions and to define its complex binding dynamics to various C3 natural ligands. Read More
Xencor Inc. at the end of 2013 raised $70 million with its initial public offering. The funds were targeted to support clinical development of FC-engineered antibody candidates XmAb5871 and XmAb7195. Read More
The FDA released a draft guidance on informed consent that, when finalized, will update a guidance issued in 1998. The draft describes general requirements, basic and additional elements of informed consent, documentation, and responsibilities of the FDA, sponsor, investigator and institutional review board. Read More
Immatics Biotechnologies GmbH, of Tuebingen, Germany, said it received €22 million (US$29.77 million) to complete a series D financing round. Read More
Cara Therapeutics Inc., of Shelton, Conn., said it earned a $500,000 milestone payment from Maruishi Pharmaceutical Co. Ltd., of Osaka, Japan, for the completion of its phase I trial of the I.V. formulation of Cara's kappa opioid agonist, CR845, in Japan. Read More
Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., reported interim data from the phase IV PRISM II study, showing that treatment with Nuedexta (dextromethorphan hydrobromide) substantially reduced symptoms of pseudobulbar affect (PBA) in patients with Alzheimer's. Read More
Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., said the FDA has granted breakthrough therapy designation to nintedanib, a tyrosine kinase inhibitor, currently under FDA review. Read More