Debating whether drug and device companies should be able to discuss scientific information about the off-label uses of their products may be an interesting academic exercise for some, but access to that information could be a matter of life or death for patients whose only treatment options are off-label. Read More

HONG KONG – Newly capitalized, thanks to an IPO of its contract drug manufacturing arm that surged on its first day of trading, South Korea's Samsung Group is now looking to take a larger slice of the global biotechnology market pie. Read More

Currently, standard antidepressants – the selective serotonin reuptake inhibitors (SSRIs) – target serotonin. But serotonin is far from the only transmitter that is out of balance in depression. Read More

HALF MOON BAY, Calif. – The nascent "internet of things," (IoT) an evolving, borderless network of small, sensor-laden devices that is expected to transform at least some aspects of health care and clinical trials, holds great promise but also significant challenges that, for now, continue to stymie some of its potential, panelists at the Techonomy Health Roundtable said Wednesday. Read More

Gilead Sciences Inc.'s Vemlidy – better known as tenofovir alafenamide, or TAF – won FDA approval as expected for treating adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Read More

Cornerstone Pharmaceuticals Inc., of Cranbury, N.J., received a $10 million investment for a minority interest from IDT Corp., of Newark, N.J. Under the investment agreements, IDT has board representation, and IDT and its co-investors have the right to acquire a majority interest in Cornerstone, which develops oncology drugs. The company's lead compound, CPI-613, has generated encouraging preliminary results in early stage trials in patients with advanced pancreatic cancer, acute myeloid leukemia and T-cell lymphoma, IDT said. Read More

Redhill Biopharma Ltd., of Tel Aviv, Israel, said it concluded a type B meeting with the FDA on its chemistry, manufacturing and controls aspect of the RBH-105 phase III program. Subject to final minutes of the meeting, the FDA accepted the firm's manufacturing plan for an NDA to be submitted for the fixed-dose, oral combination therapy for the eradication of H. pylori infection, subject to positive results from the planned confirmatory phase III study. Read More

Halozyme Therapeutics Inc., of San Diego, and Genentech, a member of the Roche Group, of Basel, Switzerland, said they will collaborate on clinical studies evaluating up to eight different tumor types beginning next year. The first study will be a phase Ib/II open-label, multi-arm, randomized, global study, led by Genentech to evaluate its cancer immunotherapy, Tecentriq (atezolizumab), an anti-PD-L1 monoclonal antibody, in combination with Halozyme's investigational drug, PEGPH20, in six tumor types. Halozyme will supply its drug only for the Genentech study. Read More

Despite sliding past an interim futility analysis in February 2015, Anthera Pharmaceuticals Inc.'s blisibimod couldn't hit the phase III endpoint against systemic lupus erythematosus (SLE) in the trial called CHABLIS-SC1 – an "obviously disappointing" outcome that the firm's chief medical officer (CMO), William Shanahan, blamed on the high placebo response. Read More