Oncolys Biopharma Inc. joined the ranks of dealmakers in the oncolytic virus therapeutic space, given a boost by last year’s FDA go-ahead for the first agent, Imlygic (talimogene laherparepvec) for melanoma from Amgen Inc. Read More
SHANGHAI – Established in 2005, Beike Biotechnology Co. Ltd., of Shenzhen, is one of China’s pioneering stem cell providers and until just a few years ago was very active at treating patients with stem cells. But when the rules changed in 2012 forbidding charging patients for stem cell treatments, Beike had to do some strategic business model retooling. Read More
BEIJING – China is working on an improved naming system for biologics and biosimilars to better ensure drug safety and good drug administration, according to national authorities. And the system would bring the country closer to internationally recognized naming rules. Read More
Vaccination with a heat-killed soil bacterium both protected mice from colitis and protected them from the behavioral consequences of chronic stress, a team from the University of Colorado has found. The work potentially suggests “a way to lower risk for a number of diseases related to inappropriate inflammation,” Christopher Lowry told BioWorld Today. Read More
SHANGHAI – Sorrento Therapeutics Inc., of San Diego, reported that STI-004 proved to be safe and efficacious in both adult and adolescent patients suffering from allergic asthma when compared to placebo, successfully completing a combined phase II/III study in China. Read More
Electronic health records (EHRs) may or may not be ready for prime time, but a new FDA draft guidance for the use of EHRs in conjunction with clinical trials states that a study sponsor is responsible for ensuring that updates to a clinic’s EHR system will have no impact on the data transmitted to the sponsor from the clinical study site. Read More
Galapagos NV, of Mechelen, Belgium, issued 140,770 new ordinary shares on May 19 for a total capital increase of about €1.48 million (US$1.65 million). Read More
Otonomy Inc., of San Diego, said the Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through status and established a new billing code for Otiprio (ciprofloxacin otic suspension), a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement, which will become effective July 1. Read More
Acorda Therapeutics Inc., of Ardsley, N.Y., said it will discontinue development of Plumiaz (diazepam) nasal spray, in development for treating seizure clusters in epileptics, after data from an ongoing trial did not demonstrate the bioequivalence to Diastat rectal gel needed for filing a new drug application under the 505(b)(2) pathway. Read More
T cells from healthy blood donors could recognize cancer antigens that were not recognized by the patients' own T cells, and gene transfer of the T-cell receptor back to the patients' T cells allowed them to also recognize the cancer antigens, suggesting that outsourcing antigen recognition might be one path to cancer immunotherapy. Read More
