Aztherapies Inc.'s new phase III approach in Alzheimer's disease (AD), ALZT-OP1, combines two well-characterized small molecules in optimized form – inhaled mast cell stabilizer cromolyn and orally given ibuprofen – for a multimodal attack of the condition at an early stage, tamping down "the big fire that's burning in the brain," Chief Medical Officer (CMO) Karen Reeves told BioWorld. Formerly with New York-based Pfizer Inc., Reeves was not the first to characterize AD as a "ticking time bomb." Read More
Aveo Oncology Inc. and Kyowa Kirin Co. Ltd. amended their 2006 license agreement so that Kyowa Kirin can buy back the non-oncology rights of tivozanib in Aveo territories, including the U.S. and the EU, while Aveo retains U.S. rights in cancer. Read More
Fresh off a second quarter featuring what Exelixis Inc. CEO Michael Morrissey called "strong momentum" for its lead product, Cabometyx (cabozantinib), the California company has inked a multimillion-dollar oncology deal with Bangalore, India-based Aurigene Discovery Technologies Ltd., a small-molecule specialist owned by Dr. Reddy's Laboratories Ltd. Read More
"It's a rare window into seeing how the FDA makes decisions because the proceedings are open unlike many of the other decisions they make," Audrey Zhang, a medical student at the New York University School of Medicine, said on why she decided to embark on crunching the numbers from 376 votes by FDA advisory committee meetings from 2008 to 2015. Read More
LONDON – Predictimmune Ltd. has raised a £10 million (US$12.2 million) series B round, enabling it to accelerate commercialization of its prognostic test for inflammatory bowel disease (IBD) in the U.S. and Europe. Read More
Fasten your seatbelts. The U.S. biosimilar market is about to take off. That's the message the FDA seems to be signaling with its fiscal 2020 BsUFA fees, which go into effect Oct. 1. Read More
Scientists from University Hospital Freiburg and the NIH have created mice that combine "microbiota and pathogens at all body sites and the tractable genetics of C57BL/6 mice." Read More
Vanda Pharmaceuticals Inc., of Washington, reported that combined net sales from Hetlioz (tasimelteon) and Fanapt (iloperidone) were $59.1 million in the second quarter, representing a 24% increase from $47.7 million in the first quarter and a 25% increase from $47.4 million in the second quarter of 2018. Read More
Arocell AB, of Uppsala, Sweden, said it entered a collaboration with the Dana Faber Cancer Institute to evaluate Arocell's TK 210 ELISA assay on CDK4/6 inhibitor-treated patients. Read More
Hemostemix Inc., of Calgary, Alberta, said it entered a loan agreement with J.M. Wood Investments Ltd. (JMWI) for a secured loan in an aggregate principal amount of up to $2 million. Read More
