G1 Therapeutics Inc., of Research Triangle Park, N.C., entered a clinical trial collaboration with Astrazeneca plc, of Cambridge, U.K., to test G1's CDK4/6 inhibitor, G1T-38 with Astrazeneca's EGFR tyrosine kinase inhibitor, Tagrisso (osimertinib), in patients with EGFR mutation-positive non-small-cell lung cancer. Read More
Dynamk Capital, of Englewood Cliffs, N.J., a new life sciences venture capital fund, said it invested $500,000 in New York-based Envisagenics Inc., leading the firm's $2.25 million seed round. Read More
Dova Pharmaceuticals Inc., of Durham, N.C., said the NDA for avatrombopag has been accepted for filing and has been granted priority review by the FDA with a PDUFA date of May 21, 2018. Read More
HONG KONG – Hong Kong-based Lee's Pharmaceutical Holdings Ltd. has signed a co-development deal with Beijing Shenogen Pharma Group Ltd. to combine Lee's PD-L1 antibody with Shenogen's lead traditional Chinese medicine-derived small-molecule drug. Read More
LONDON – The U.K. is seeking to dispel the clouds of Brexit uncertainty with a new industrial strategy that, in addition to promising a conducive business and regulatory environment, includes a side serving of targeted support for life sciences. Read More
Receptor tyrosine kinases (RTKs) are one of the biopharma industry's most familiar frenemies. Aberrant RTK signaling is a driver in many forms of cancer, and is targeted by dozens of inhibitors. Read More
DUBLIN – Shares in Auris Medical AG (Nasdaq:EARS) plummeted more than 60 percent during premarket trading Tuesday on news that its lead drug candidate, AM-111, missed the primary endpoint of a phase III trial, called Healos, in patients who experienced sudden deafness. Read More
Phaserx Inc. CEO Robert Overell told BioWorld the firm has paused its lead, preclinical effort in intracellular enzyme replacement therapy (iERT) as the search continues for "a strategic transaction, including a potential merger" to advance the pipeline. "The goal is to get this technology and these programs into the hands of a group who can adequately capitalize it and capitalize on it," he said. Read More
LONDON – Substandard and falsified drugs in every therapeutic category, both high- and low-cost, patented and generic, are infiltrating pharmaceutical supply chains worldwide, according to the first analysis of reports to the World Health Organization's (WHO) global surveillance system. Read More
Cincinnati-based Cinrx Pharma LLC, a company advancing four early stage candidates for gastrointestinal, cardiovascular and dermatologic indications, has completed a $10 million series B financing backed by both current and new investors. The company, led in part by a roster of former executives of Teva Pharmaceutical Industries Ltd., expects to file investigational new drug applications for all four candidates in the first half of 2018. Read More
SHANGHAI – When Beyondspring Pharmaceuticals Inc., a clinical-stage immuno-oncology biopharma started its U.S.-China development strategy for lead candidate plinabulin, getting a first-in-class drug past China's regulators was an unwieldy prospect, often taking years longer than the U.S. But after China's most recent round of regulatory reforms, things are looking up considerably. Read More
