Three years after a new drug application was first submitted for leukemia drug omacetaxine mepesuccinate, during which the product moved twice into different hands via M&A transactions, the FDA granted a long-awaited nod Friday. Read More
The hot-potato history of the drug candidate that carries the strongest hope for sickle-cell disease (SCD) patients goes back more than two decades, but investors hope the buck will stop with Adventrx Pharmaceuticals Inc. – and plenty of bucks lie ahead, should ANX-188 win at last in upcoming Phase III trials. Read More
Researchers at the Yale University School of Medicine have shown that an antibody that was originally isolated from a mouse model of lupus may be useful as a targeted cancer therapy. Read More
In a two-day meeting that begins this morning, the FDA's Drug Safety and Risk Management (DSaRM) Advisory Committee (adcom) will examine the potential impact of rescheduling hydrocodone combination products – those mixed with other analgesics or as an antitussive – from Schedule III to II, similar to hydrocodone alone. Read More
Merck & Co. Inc., of Whitehouse Station, N.J., shrugged off the worst effects of the August 2012 loss of market exclusivity for its blockbuster drug Singulair (montelukast sodium) in the U.S. Read More
• Pharmaxis Ltd., of Sydney, Australia, said the National Institute for Health and Clinical Excellence in the UK issued a positive recommendation in its final appraisal determination for Bronchitol (mannitol dry powder for inhalation), approved to treat adult cystic fibrosis patients as an add-on therapy to best standard of care. Read More
• Galena Biopharma Inc., of Lake Oswego, Ore., said data from a Phase I/II study showed that NeuVax (nelipepimut-S or E75) decreased circulating tumor cells in 16 of 26 breast cancer patients during vaccine treatment. Read More
• BioMarin Pharmaceutical Inc., of Novato, Calif., reported a GAAP net loss of $5.4 million, or $0.04 per share for the third quarter of 2012, compared to a GAAP net loss of $17.7 million, or 0.16 per share, for the third quarter of 2011. Read More
Scientists from Stanford University have published data disputing the idea that disease relapse is due to cells with stem cell-like properties. Read More
