Xcovery Inc. launched the phase III trial of X-396 (ensartinib), its lead ALK inhibitor, as a first-line treatment in patients with ALK+ non-small-cell lung cancer. The global, open-label, randomized eXalt3 study is expected to enroll approximately 400 patients to evaluate the efficacy and safety of X-396 head-to-head against Pfizer Inc.'s Xalkori (crizotinib). Read More
Computational-chemistry expert Schrödinger Inc. collaborated with his firm "as a co-founder almost," Morphic Therapeutic Inc. CEO Praveen Tipirneni told BioWorld Today, which should provide "an interesting advantage" in working with crystal structures to design oral integrin-targeting drugs. Read More
LONDON – Websites publishing details of payments from pharma companies to health care professionals have gone live as Europe presses the button on its version of the U.S. Sunshine Act, and makes information on money paid to individuals available for public scrutiny for the first time. Read More
Fear of drug-resistant superbugs continues to escalate across the globe, but the U.S. health system now has a new infection control weapon to use against one of the most threatening bacteria – carbapenem-resistant Enterobacteriaceae (CRE). Read More
Health Canada published final regulations in the Canada Gazette Part II requiring mandatory reporting by industry of drug shortages and discontinuations of sales and said it is on track to implement those regulations by spring 2017. Read More
Intercept Pharmaceuticals Inc., of New York, said it priced its public offering of $400 million aggregate principal amount of 3.25 percent convertible senior notes due 2023. Read More
Therapeuticsmd Inc., of Boca Raton, Fla., said it expects the new drug application for Yuvvexy, the conditionally approved trade name for the company's TX-004HR drug candidate, will be submitted to the FDA on or before July 15. Read More
Beigene Ltd., of Waltham, Mass., reported dosing the first patient in a phase I trial of BGB-3111, a Bruton's tyrosine kinase inhibitor, in combination with BGB-A317, a PD-1 antibody, for the treatment of various B-cell malignancies. The study is designed to assess the safety, tolerability, pharmacokinetics and antitumor activities of that combination in patients with B-cell lymphoid malignancies. BGB-3111 will be dosed orally and BGB-A317 will be administered intravenously every three weeks. It is anticipated that about 25 patients will be enrolled into the study. Read More
