Kitov Pharmaceuticals Holdings Ltd., of Tel Aviv, Israel, said lead drug candidate, KIT-302, met the FDA standards to establish six-month stability. The study, conducted by Kitov's manufacturing partner, Dexcel Pharma, showed that nine pivotal batches of KIT-302 – three in each dosage form (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg and 200 mg/2.5 mg) – met six-month stability criteria, enabling the inclusion of registration batches in the company's new drug application submission, planned for the first quarter of 2017. Read More
Xencor Inc., of Monrovia, Calif., said it completed an underwritten public offering of 5.27 million shares of its common stock at $24 each, including 687,750 shares sold following the full exercise of an option previously granted to the underwriters to purchase additional shares of common stock. The gross proceeds were approximately $126.5 million with the net proceeds to be used for working capital and general corporate purposes, including additional investments in advancing its lead compound XmAb 5871 through later stages of clinical development and additional investment in its immune-oncology pipeline and technology. Read More
Cascadian Therapeutics Inc., of Seattle, said that following a meeting with the FDA and discussions with their external steering committee, it has amended the HER2CLIMB phase II trial of tucatinib (also known as ONT-380) by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support registration. Read More
The 21st Century Cures Act needed three days to get through a procedural vote and a final vote on the floor of the U.S. Senate, but the legislation performed well on arrival, passing by a margin of 94-5 to the applause of the life science industries. The bill, which would pump $500 million into the FDA's coffers and $6.3 billion into the NIH account, needs only President Obama's signature to become law, providing what proponents say will be a new era of hope for patients afflicted by a variety of diseases, including cancer. Read More
LONDON – A new frontier has opened up in the search for Alzheimer's therapies, with researchers at Massachusetts Institute of Technology reporting they can reduce beta amyloid plaques in mouse models using lights flickering at specific frequencies to stimulate neural circuits. Read More
One month after shares of Anthera Pharmaceuticals Inc. (NASDAQ:ANTH) took a 30 percent haircut following a phase III miss by blisibimod in the lead indication of systemic lupus erythematosus (SLE), investors did an about-face on maturing data from the phase BRIGHT-SC proof-of-concept study of the same agent in individuals with IgA nephropathy (IgAN), also known as Berger's disease. Read More
SHANGHAI – Shanghai-based Hutchison Medipharma Co. Ltd. presented phase I data for epitinib at the World Conference on Lung Cancer in Vienna showing that epitinib is a safe EGFR inhibitor with the ability to cross the blood-brain barrier (BBB). Read More
DUBLIN – Neurimmune AG and TVM Capital Life Science formed a joint venture, AL-S Pharma AG, a single-asset play that will take on a preclinical Neurimmune program in amyotrophic lateral sclerosis (ALS). Read More
HONG KONG – Sanofi SA entered a strategic alliance with Taiwan's JHL Biotech, Inc. which could provide a cash infusion and speed up the commercialization of JHL Biotech's biosimilar drugs in China. Read More
