An elevated placebo response matching the efficacy of experimental schizophrenia drug ITI-007 in a phase III trial sent shares of its developer, Intra-Cellular Therapies Inc., (NASDAQ:ITCI) down 63.6 percent to close at $15.42 on Thursday. Read More
Amgen Inc. took a global exclusive license, with an option on a second, to develop and commercialize cardiovascular treatments using the subcutaneous RNAi delivery platform developed by Arrowhead Pharmaceuticals Inc. Read More
Researchers from the University of California at San Francisco reported that they have engineered T cells to both hone to targets of their choice, and set off gene expression programs of the researchers' choosing. Read More
Waiting until almost the 11th hour, Congress passed a continuing resolution (CR) late Wednesday that will keep the U.S. government running through the first 10 weeks of fiscal 2017. Read More
SILVER SPRING, Md. – Can the development of antimicrobials and susceptibility tests be coordinated more effectively? Yes, according to attendees of an FDA workshop Thursday on challenges and opportunities for getting clearance for antimicrobial susceptibility tests (ASTs) shortly after antimicrobial drug approval. Read More
The FDA awarded a label expansion for Roche Holding AG's cobas EGFR mutation test to be used as a companion diagnostic with London-based Astrazeneca plc's non-small-cell lung cancer (NSCLC) treatment, Tagrisso (osimertinib), an approval that brings together two firms competing in the NSCLC treatment market, which is slated to grow to about $7.9 billion in 2020, according to a report from Global Business Intelligence. Read More
Galmed Pharmaceuticals Ltd., of Tel Aviv, Israel, said it raised approximately $5 million under an at-the-market (ATM) financing executed by Cantor Fitzgerald. Read More
Abbvie Inc., of North Chicago, said it strengthened its manufacturing capabilities following the opening of a small-molecule active pharmaceutical ingredient (API) facility at a Singapore manufacturing site. Read More
Eisai Inc., of Woodcliff Lake, N.J., said it started a randomized phase III study that will evaluate the efficacy and safety of two regimens containing Eisai's multiple receptor tyrosine kinase inhibitor lenvatinib, marketed in the U.S. as Lenvima. One combination will add lenvatinib to anti-PD-1 immunotherapy Keytruda (pembrolizumab, Merck & Co. Inc.) and the other will test lenvatinib in combination with everolimus, both vs. Sutent (sunitinib, Pfizer Inc.), in patients with advanced renal cell carcinoma in the first-line setting. The CLEAR study is designed to assess the potential of those combinations to extend progression-free survival. Read More
Sorrento Therapeutics Inc., of San Diego, named Miranda Toledano executive vice president of corporate development and president of LA Cell, Sorrento's joint venture with City of Hope. Read More
