Whether it's perseverance or perseveration remains to be seen. But between the strong scientific evidence implicating amyloid beta in Alzheimer's disease (AD) and evidence of some progress in clinical trials, neither industry nor academia is willing to call it quits on pursuing amyloid beta as a target. Read More
DUBLIN – 2017 marks the year that the connection between European biotech and Nasdaq solidified into what now looks to be an unbreakable bond. As of Dec. 22, European biotechs engaged in drug development raised a record $2.75 billion in IPOs and follow-on offerings on the U.S. exchange, dwarfing the previous record total of $1.79 billion raised in 2015. European firms raised $949 million in eight IPOs and another $1.8 billion in 16 secondary offerings in the past year. Read More
HONG KONG – Nagoya, Japan-based Askat Inc. has signed a $1.2 billion licensing deal for two of its immune-oncology compounds with Arrys Therapeutics Inc., of Cambridge, Mass. Arrys was granted research, development and marketing rights for Askat's two prostaglandin E2 receptor 4 (EP4) antagonists, AAT-007 and AAT-008, in the global market excluding China. Read More
SHANGHAI – Zai Labs Ltd., of Shanghai, nabbed Greater China rights for FPA144, a first-in-class fibroblast growth factor (FGF) monoclonal antibody for gastric and gastro-esophageal junction cancer being developed globally by Five Prime Therapeutics Inc., of San Francisco. Read More
HONG KONG – Roivant Sciences Ltd., of Basel, Switzerland, has inked a $502.5 million deal for an autoimmune treatment developed by South Korea's Hanall Biopharma Co. Ltd. Read More
The FDA announced that Auromedics Pharma LLC, of East Windsor, N.J., has recalled one lot of Zyvox (linezolid) for injection due to the presence of white particulate matter identified as mold. The lot was distributed to hospitals between May 15 and Aug. 14, 2017, with an expiration date of August 2018, and the recall was prompted by the discovery of particulate matter in a single bag of the antibacterial. Linezolid is indicated for use in treatment of Gram-positive bacteria, such as nosocomial pneumonias. Read More
Aptose Biosciences Inc., of San Diego and Toronto, said the FDA granted orphan drug designation to its pan-FLT3/pan-BTK inhibitor, CG'806, for acute myeloid leukemia. The company intends to begin clinical trials in both acute myeloid leukemia and B-cell malignancies in 2018. Read More
Rezolute Inc., of Louisville, Colo., said it entered into a common stock purchase agreement with Lincoln Park Capital Fund LLC (LPC), and will now have the right and sole discretion to sell up to $10 million worth of shares to LPC over a 36-month period, subject to certain limitations. Rezolute says it will control the timing and amount of any future investment and LPC will be obligated to make purchases in accordance with the agreement. Proceeds will be used for operations and the development of product candidates and product collaborations. Read More
Cstone Pharmaceuticals Co. Ltd., of Suzhou, China, submitted an application for clinical trial approval to Human Research Ethics Committees of Linear Clinical Research Center in Australia for CS3006, a small-molecule inhibitor of mitogen-activated protein kinase. Read More
