With "solid, convincing evidence that the speculations will actually be realized" in hand, Kite Pharma Inc.'s chief medical officer (CMO), David Chang, told BioWorld Today that the company – just as it hit the primary endpoint in the pivotal trial – will meet the targeted filing of the BLA for its lead chimeric antigen receptor (CAR) T-cell candidate, axicabtagene ciloleucel. Read More

Accera Inc.'s metabolic-focused Alzheimer's candidate, AC-1204, has foundered in the company's phase III NOURISH AD trial, failing to deliver statistically significant improvements in memory and cognition vs. placebo for people with mild to moderate Alzheimer's disease. A reformulation of the drug between a successful phase II trial and the phase III study yielded suboptimal exposure, contributing to the lack of efficacy, the company said. Read More

As the biopharma industry paused on Rare Disease Day to assess its progress and consider the plight of patients still waiting for therapeutic options, two players at opposite ends of the U.S. took the field in Duchenne muscular dystrophy (DMD). Boston-based Exonics Therapeutics Inc. is plying CRISPR/Cas9 gene editing technology with a goal of correcting the mutations that cause DMD and other neuromuscular diseases. Read More

A study by Chinese researchers has identified a key suppressor of apoptosis in nonalcoholic steatohepatitis (NASH), and then showed that a small peptide segment derived from it ameliorated the currently untreatable liver disease in mice and nonhuman primates. Read More

To say that the discovery leading to Aobiome LLC's approach to treat disease by targeting the microbiome came via an unconventional method is an understatement. As the story goes, founder David Whitlock, a Massachusetts Institute of Technology chemist, during a stroll at a local farm, began wondering why horses rolled around in the dirt. Read More

The FDA posted a warning letter Tuesday that cited contamination problems with sterile drugs at a Pfizer Inc. plant that's expected to delay approval of a Copaxone (glatiramer acetate, Teva Pharmaceutical Industries Inc.) 40-mg generic developed by Momenta Pharmaceuticals Inc. and Sandoz Inc. Read More

Corbus Pharmaceuticals Holdings Inc., of Norwood, Mass., is raising net proceeds of about $27.1 million through the sale of 3.9 million shares of its common stock in a registered direct offering. Read More

Amarin Corp. plc, of Bedminster, N.J., reported fourth-quarter revenue of $38.7 million, including $38.4 million from net revenue on U.S. sales of triglyceride-lowering drug Vascepa (icosapent ethyl). Read More

Immune Pharmaceuticals Inc., of New York, said it broadened enrollment criteria based on data from three patients who have completed treatment to date in its 10-patient, open-label study of bertilimumab in bullous pemphigoid (BP). Read More

Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA accepted the NDA and granted priority review for SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia (TD). Read More