While the FDA may have opened the biosimilar pipeline with its approval of Sandoz Inc.'s Zarxio Friday, a lot of heavy lifting has to be done before biosimilars are a viable market in the U.S. Read More
CTI Biopharma Corp.'s pacritinib hit the primary endpoint in the first phase III study evaluating the next-generation JAK2/FLT3 multikinase inhibitor in myelofibrosis patients, with top-line data also showing benefit in a subset currently not helped by marketed JAK2 inhibitor Jakafi (ruxolitinib), findings that could provide crucial differentiation in the marketplace. Read More
Sucampo Pharmaceuticals Inc. is returning to R-Tech Ueno Ltd. all licenses for the eye drug unoprostone isopropyl in the wake of a phase III study in which the drug failed to meet its primary endpoint of improving mean retinal sensitivity in people with retinitis pigmentosa (RP) vs. a placebo with statistical significance. Read More
SHANGHAI – Six months after London-based Glaxosmithkline plc officially apologized to the Chinese government for bribing non-government personnel, a GSK spokesperson confirmed to BioWorld Today that more than 100 employees have left the China office for violating the company's code of conduct. Read More
HONG KONG – New antibiotic agents are urgently needed to overcome the burgeoning problem of antimicrobial resistance in infectious bacteria, but novel agents alone may not be sufficient to prevent a return to the dark days of the pre-antimicrobial era, an infectious disease specialist has warned. Read More
LONDON – GW Pharma plc is poised to launch four U.S. phase III trials of its second cannabis-derived drug Epidiolex, in the treatment of childhood epilepsy. Read More
Inflection Biosciences Ltd., of Dublin, said it closed a second equity fundraising totaling €725,000 (US$786,700) from new and existing private investors. Read More
Cormedix Inc., of Bedminster, N.J. extended to April 30 the expiration date for all publicly traded warrants, which can be exchanged for company shares (NYSE:CRMD) at differing times, based on their membership in one of two tranches. The warrants had previously been set to expire March 24. Read More
Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, completed enrollment in TELESTAR, its pivotal phase III trial of telotristat etiprate for patients with carcinoid syndrome. Read More