The FDA's refusal to accept a new drug application for PTC Therapeutics Inc.'s Duchenne muscular dystrophy (DMD) candidate Translarna (ataluren) left the company pondering next steps as its shares (NASDAQ:PTCT) plunged, falling 61.6 percent, or $17.42, to close at $10.84 on Tuesday. Read More

SHANGHAI – Impact Therapeutics Inc., a China-based biotech dedicated to the discovery and development of new drugs, has received $10 million in series B financing from five investors to support the virtual firm's lead candidate, a poly ADP-ribose polymerase (PARP) inhibitor that may have the potential to be best in class in China, if not globally. Read More

The candidate that may become not only the first-ever topical nitric-oxide (NO) macromolecule approved but also the first new chemical entity for acne in 20 years took one more step toward potential marketing as Novan Inc. kicked off its phase III program with topical gel SB204. Read More

HONG KONG – New results from researchers at the University of Kyoto in Japan suggest that pancreatic exocrine tissue, which is primarily involved in digestion, could also play an important role in the development of diabetes, a key finding that could lead to new treatments for the disease, including the potential for stem cell-based therapies. Read More

Oncbiomune Pharmaceuticals Inc. is pressing ahead with a phase II trial of Proscavax, its therapeutic vaccine to treat prostate cancer, after preliminary data from a small phase I trial showed the treatment was safe and suggested initial indications of efficacy. Read More

HONG KONG – South Korea's Samsung conglomerate is pouring tens of millions into Middle East respiratory syndrome (MERS) research, less than a year after an oversight at one of the company's hospitals facilitated the spread of the deadly virus. Read More

WASHINGTON – The Obama administration's bid to place cardiologist Robert Califf into the FDA commissioner's office continued to encounter strong headwinds on the Senate floor Tuesday as two senators offered impassioned pleas to their colleagues to come to grips with what is often described as an epidemic of opioid addiction. . Read More

Redwood Pharma AB, of Stockholm, completed a SEK6.6 million (US$800,000) private placement to fund development of its lead product candidate, RP101, for the treatment of chronic dry eye disease. The active substance has been successfully tested in two phase II studies and will now be tested in combination with Intelligel, the company's drug delivery system. That technology was obtained through an exclusive, worldwide license from Broda Technologies Co. Ltd., of Shanghai. Read More

Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported net product revenues from sales of leukemia drug Iclusig (ponatinib) were $33.3 million for the fourth quarter of 2015, an increase of 56 percent from the fourth quarter of 2014. For the year, revenues were $112.5 million, an increase of 102 percent over 2014 product revenues.  Read More

Amarantus Bioscience Holdings Inc., of San Francisco, said it completed the growth and testing components of its confirmatory engineering run, positioning the company to be ready to supply its Engineered Skin Substitute for a planned phase II study of the autologous cell product's use in treating full thickness thermal burns covering more than 50 percent of the body. Read More

Cytodyn Inc., of Vancouver, British Columbia, submitted to the FDA a protocol for a phase III monotherapy trial and the top-line report for its phase IIb monotherapy trial of PRO 140 to treat patients with HIV. Read More