Genexine Inc., of Seoul, South Korea, said the FDA granted orphan drug designation to GX-H9 to treat growth hormone deficiency. The next-generation recombinant human growth hormone is being studied in once-weekly and twice-monthly dosing schedules. The company is scheduled to present data this weekend in Tokyo at the 9th Biennial Asia Pacific Pediatric Endocrinology Society/50th Annual Japanese Society for Pediatric Endocrine Society Conference. Read More

NEW DELHI – Marking what may be a first, Mylan NV and Biocon Ltd. have submitted Mylan's biologics license application (BLA) to the FDA for a proposed biosimilar of branded trastuzumab, MYL-1401O, to treat certain forms of breast and gastric cancers. Read More

HONG KONG – China's health care sector is seeing a surge of mergers and acquisitions thanks to regulatory reforms that are expected to drive development. Case in point is Sciclone Pharmaceuticals Inc., a San Francisco-based drug developer that markets drugs in China. The company confirmed this month that it received an unsolicited $570 million acquisition offer. Read More

TOKYO – New drug approvals in Japan dropped to a five-year low in 2015, according to the latest report from the PMDA. While reviews are getting faster for standard products, reviews for priority products have grown increasingly longer. Read More

Most of the attention lavished on CRISPR is about its capacity to edit mammalian genes, but a study by New Zealand researchers has given new insight into the functions of CRISPR in bacteria. Read More