To mitigate shortages of Mylan NV's Epipen (epinephrine), the FDA Tuesday extended the expiration date of specific lots of the company's 0.3 mg auto-injectors by four months beyond the labeled expiration date. The change beyond the approved 20-month shelf life was based on stability data provided by Mylan, of Hertfordshire, U.K. Read More
Recombinetics Inc., of St. Paul, Minn., focused on gene-editing solutions for human health and animal agriculture, said it completed a $34 million series A financing round. Proceeds will be used to accelerate new research and development and build out the business development, product marketing and management team to take advantage of licensing and co-development opportunities. Read More
Cersci Therapeutics Inc., of Dallas, said it received notice from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) that it has been awarded a phase I small business technology transfer (STTR) grant totaling over $220,000. The funds will support the preclinical development of small molecules for the treatment of migraine. Read More
An NIH workshop aimed at promoting the efficient development and regulation of gene therapies highlighted a crucial bottleneck for the field Tuesday, as policy members of the rare disease community raised substantial questions about how to value and pay for the therapies. With three gene therapies already approved in the U.S. and a growing queue of new ones in development, panelists painted a picture of financial and institutional innovation struggling to keep pace with medical innovation. Read More
Two-year-old Drugcendr Inc. became the latest biopharma to take a stab at pancreatic cancer by advancing lead compound, CEND-1, into a phase I trial in individuals with metastatic pancreatic ductal adenocarcinoma (PDAC) undergoing combination therapy with Abraxane (nab-paclitaxel, Celgene Corp.) and gemcitabine. Read More
When it comes to developing new antibacterials, "FDA approval is no longer the finish line because it doesn't result in sales," Kevin Outterson, executive director of Carb-X, said at an FDA workshop on developing nontraditional therapies for bacterial infections. Read More
HONG KONG – Jiangsu Hengrui Medicine Co. Ltd. said the China National Drug Administration (CNDA) granted a conditional approval to its self-developed compound pyrotinib for treating HER2-positive breast cancer. The approval was based on clinical data from phase II studies, demonstrating China's effort in marketing domestic innovative drugs faster. Read More
HONG KONG – China purged about 40 provincial and local officials, including top staff of China's drug watchdog, after a meeting of the Politburo Standing Committee, led by President Xi Jinping, who pledged to punish rabies vaccine maker Changchun Changsheng Bio-technology Co., of Jilin Province, for stirring up fears for public health. Read More
