Keryx Biopharmaceuticals Inc.'s ferric citrate will go to market after approval Friday by the FDA, two days before the drug's Sunday PDUFA date. But the agency rescinded approval of the long-used trade name Zerenex, forcing the company to go back to the drawing board for a name that passes muster. Read More
LONDON – The World Health Organization (WHO) is moving ahead to test experimental Ebola treatments on patients in West Africa, in an unprecedented series of expedited trials of between five and 10 drugs that have been identified by an expert panel as having the potential to make an impact on the current outbreak. Read More
Merck & Co. Inc.'s FDA clearance, almost two months earlier than expected, of PD-1-targeting Keytruda (pembrolizumab) for melanoma holds the title for gaining the first U.S. approval of a drug in the class, but restrictions in the label have meant "a lot of head-scratching," said Robert Pierce, formerly director of Merck's anti-PD-1 development team. Read More
LONDON – An experimental treatment in a mouse model of multiple sclerosis has delivered promising results, raising hopes that similar treatments could help patients with that and other autoimmune conditions, such as type 1 diabetes, Graves' disease and systemic lupus erythematosus. Read More
Global pharma sales are on track to exceed $1 trillion for the first time in 2014 as drugmakers refine their abilities to explore new scientific opportunities and learn to let go of faltering projects earlier rather than later, according to analysis by CMR International, a Thomson Reuters business. Read More
Loxo Oncology Inc., of Stamford, Conn., closed its initial public offering of about 5.9 million shares, including 642,000 shares of common stock that were issued upon the exercise of the underwriters' overallotment option to purchase additional shares, at a price to the public of $13 per share. Read More
Oncomed Pharmaceuticals Inc., of Redwood City, Calif. said the FDA removed a partial clinical hold on a phase I trial of ipafricept, its Leverukusen, Germany-based Bayer AG-partnered Wnt pathway inhibitor, after providing the agency with safety and efficacy data and revised study protocols. Read More
Recro Pharma Inc., of Malvern, Pa., disclosed a clinical strategy update following findings from a prespecified interim analysis conducted on the initial half of patients who completed enrollment in the company's REC-13-012 trial testing intranasal dexmedetomidine, Dex-IN, in the treatment of acute postoperative pain following bunionectomy surgery on post-op day zero. Read More
Actavis plc, of Dublin, said the FDA accepted for filing the firm's ceftazidime-avibactam, its investigational antibiotic for the treatment of patients with complicated urinary tract Infections and complicated intra-abdominal infections, including those caused by multidrug-resistant gram-negative bacterial pathogens. Read More
Researchers from the University of California at San Diego have developed a red blood cell decoy that was able to soak up autoantibodies that cause autoimmune hemolytic anemia, where such antibodies attack the red blood cells. Read More
