The FDA prohibited Ranbaxy Laboratories Ltd., from manufacturing and distributing active pharmaceutical ingredients (API) from its facility in Toansa, India, for FDA-regulated drug products, making the Toansa facility subject to certain terms of a consent decree of permanent injunction entered against the pharma in January 2012. Read More
Cytrx Corp., of Los Angeles, said it started a Phase II trial to determine preliminary efficacy and safety of aldoxorubicin in HIV-infected patients with Kaposi’s sarcoma (KS). Read More
Biolinerx Ltd., of Jerusalem, said the FDA confirmed orphan drug designation for BL-8040, in combination with granulocyte colony-stimulating factor, as a treatment for stem cell mobilization prior to an autologous or allogeneic transplantation. Read More
Researchers have reported new insights into the genetic and neural mechanisms that underlie schizophrenia, and how the disease is related to other neurodevelopmental disorders at the cellular level. Read More
Cleveland Biolabs Inc. (CBLI) learned the hard way that there are limits to how much the U.S. government is willing to spend to develop drugs it hopes it will never use. Read More
After pocketing a $70 million milestone payment from partner Astrazeneca plc in November following the FDA’s acceptance of the new drug application (NDA) for lead compound naloxegol, Nektar Therapeutics Inc. turned to the public markets in a big way to advance its internal programs. Read More
IP Group plc is raising £75 million (US$124.5 million) in new funding and, in an unrelated move, acquiring Fusion IP plc outright in a stock-based deal that values the latter firm at £87.8 million. Read More
Pfizer Inc., of New York, reported top-line results from a Phase III study of ALO-02 (oxycodone hydrochloride/naltrexone hydrochloride extended-release capsules) in patients with moderate to severe chronic low back pain, showing that the drug met the primary efficacy endpoint. Read More
