Mixed data from a phase II trial in October 2014 may have presaged Eleven Biotherapeutics Inc.'s phase III top-line failure in severe allergic conjunctivitis (pink eye) with the interleukin-1 signaling inhibitor EBI-005 (isunakinra), which also proved a dud in the late-stage experiment for dry eye disease in May 2015. Read More

LONDON – A volunteer who was taken ill in the phase I trial of BIA 10-2474 – designed to target pain relief by acting on cannabinoid receptors – has died, according to Bial-Portela & Ca. SA, while five others remain hospitalized. Read More

DUBLIN – Faced with the high cost of completing phase III development for its Parkinson's disease drug, tozadenant (SYN115), Biotie Therapies Oyj opted to fold now and agree to a $363 million cash bid from Acorda Therapeutics Inc., rather than hold out in the hope that its value would rise later on the back of positive data. Read More

The Supreme Court agreed Friday to take up a case that could dilute the lethal potential of the inter partes review (IPR) as practiced by the Patent Trial and Appeal Board (PTAB). Read More

HONG KONG – South Korea's Samsung Bioepis Co. Ltd. got the first EU approval for biosimilar etanercept, a win that opens up the European market for a company that is working to become a global top-tier biosimilar maker. Read More

A lack of reliable, timely and easy-to-access data is restricting the FDA's ability to stay on top of safety issues that it commits to tracking following expedited approval of new drugs, according to a report published by the Government Accountability Office (GAO) that examined both fast track and breakthrough designations. Read More

HONG KONG — Chinese researchers have discovered that an antifungal drug can efficiently block bacterial virulence due to Staphylococcus aureus infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA) strains of the bacterium, in mouse models of infection, they reported in the Jan. 18, 2015, edition of Nature Chemical Biology. Read More

LONDON – U.K. newco Centauri Therapeutics Ltd. has acquired the alphamer anti-infective technology inspired by Nobel Laureate and inventor of the polymerase chain reaction Kary Mullis, and raised £3 million (US$4.3 million) to complete preclinical development of the lead compound. Read More

Oncobiologics Inc., of Cranbury, N.J, filed to raise up to $115 million in an IPO. The number of shares and share price have not yet been disclosed. Oncobiologics, which develops biosimilar therapeutics – lead phase III-ready candidates ONS-3010 and ONS-1045 are biosimilar versions of Humira (adalimumab, Abbvie Inc.) and Avastin (bevacizumab, Roche AG), respectively – seeks a listing on Nasdaq under the ticker ONS. Read More

Respirerx Pharmaceuticals Inc., of Gen Rock, N.J., said it reached agreement with the Medications Development Program of the National Institute of Drug Abuse (NIDA) to conduct research on its compounds CX717 and CX1739. NIDA will evaluate the company's ampakine compounds in a series of preclinical pharmacologic, pharmacokinetic and toxicologic protocols to determine their potential effectiveness for the treatment of drug abuse and addiction. Read More

Cellceutix Corp., of Beverly, Mass., said the briefing book with data collected during the phase I trial of Kevetrin for various advanced solid tumors has already been submitted to the FDA in advance of the meeting to discuss the planned phase II trial in advanced ovarian cancer. Kevetrin enhances activity of p53, a key tumor suppressor protein, in both wild-type and mutant p53-expressing tumors, the company said. Read More