Vertex Pharmaceuticals Inc. faced the music on Incivek (telaprevir), slashing 370 jobs – 15 percent of its work force – after patients turned from the flagging hepatitis C virus (HCV) drug to newer therapies. Revenues from Incivek plummeted to $85.6 million in the third quarter from $254.3 million during the same period a year earlier. Read More
Not if, but when and how. That’s the conclusion most biopharmaceutical executives have today when it comes to developing a global strategy – increasingly focused on Asia. Read More
Although opioid-induced constipation (OIC) has gotten most of the press in recent years, Charleston Laboratories Inc. may be about to change all that, given Phase III success with CL-108, which provides the pain relief of hydrocodone without the side effects that are even more prevalent: nausea and vomiting (OINV). Read More
The regulatory experts who gathered in Europe from all over the world to consider a global standard for naming biosimilars got such an earful of contradictory views that they’re likely to hold at least one more public forum before they recommend an international nonproprietary naming (INN) scheme for the follow-on biologics. Read More
A new Series D financing round worth $35 million will support Calithera Biosciences Inc.’s Phase I study of its cancer candidate, CB-839. The compound is designed to block cancer cell growth through inhibition of glutaminase. In preclinical studies, Calithera showed potent and selective activity of CB-839 against multiple tumor types. Read More
LONDON – A genomewide association study of people with Alzheimer’s disease has delivered a haul of 19 regions of the genome that are significantly associated with that disease, including 11 that have been linked with Alzheimer’s for the first time. Read More
Early stage fragment antibody developer Numab AG has regained control of a drug development program in severe asthma it originally licensed to Sucampo Pharmaceuticals Inc. more than two years ago and is now seeking Series A funding to take forward that molecule, ND003, as well as a second drug candidate, ND007, which is in development for autoimmune indications. Read More
• Pharmalink AB, of Stockholm, said Busulipo, a conditioning agent for use in cancer patients prior to hematopoietic stem cell transplantation, received orphan drug designation from the FDA. Read More
• Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., provided an update on the status of its Phase III trial with lead candidate Firdapse (amifampridine phosphase) for the treatment of Lambert-Eaton myasthenic syndrome. Read More
• Incelldx Inc., of Menlo Park, Calif., said it entered a deal with Bristol-Myers Squibb Co., of New York, related to the development of an assay for potential application of a molecular companion diagnostic intended to identify patients likely to benefit from treatment with a BMS drug currently in development. Read More
• Merck & Co. Inc., of Whitehouse Station, N.J., presented interim data from a Phase Ib trial of MK-3475, for non-small-cell lung cancer at the World Conference on Lung Cancer in Sydney. Read More