BioMarin Pharmaceutical today announced that the FDA granted KUVAN(R) (sapropterin dihydrochloride) Powder for Oral Solution and Tablets a six-month pediatric exclusivity extension. The FDA action extends KUVAN's market exclusivity to June 2015 and is based on studies submitted in response to a written request by the FDA to investigate the use of KUVAN in pediatric patients from birth to age 6
Bristol-Myers Squibb Company announced today the submission of a new drug application (NDA) on April 4, 2014 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz®, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective.
Across parts of Iraq, medical teams in white coats and gloves again roam the streets giving children polio vaccines and marking the walls of their homes, fighting a resurgent virus once more taking advantage of the country's turmoil.
Two new studies describe the latest achievements in growing body parts in a lab and transplanting them into people, this time with nostrils and vaginas. Windpipes, bladders, blood vessels and other structures have previously been created in part from a patient's own cells and then implanted.
Ian C. Read, chairman and CEO of Pfizer, Inc, was elected chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA) at the trade association’s annual meeting. Also elected were Kenneth C. Frazier, chairman, president and CEO of Merck & Co, Inc., as chairman-elect of the PhRMA Board of Directors, and George A. Scangos, Ph.D., CEO of Biogen Idec, as Board treasurer.
Moberg Pharma AB has entered into a definitive agreement with Oracain II Aps (Denmark) to acquire all assets and global rights to a novel and patent pending oral formulation of the proven substance bupivacaine, for the treatment of pain in the oral cavity.
Concerns about electronic cigarettes, including flavors and marketing that could appeal to young people, underscore the need to regulate the fast-growing industry, according to a Congressional report released Monday.
FIFA's medical chief is "really not happy" with drug-testing plans for the World Cup in Brazil because samples taken from players must be flown across the Atlantic for analysis at a laboratory in Switzerland, which could slow results.
Shares of Adamas Pharmaceuticals rose Thursday after the drug developer's initial public offering raised $48 million.
As GranuFlo lawsuits stemming from the 2012 recall of GranuFlo and NaturaLyte dialysis concentrates continue to move forward in the U.S., Bernstein Liebhard LLP notes that Fresenius Medical Care has announced a new NaturaLyte recall in Canada.
Guerbet announced that Lipiodol® was approved by the US Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act indicated for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC).
Rampant misinformation about Zohydro ER continues to be reported by the media and echoed in Washington D.C. and some states' capitals. These inaccurate and misleading statements are often made without proper context, and are intended to be sensational, to create fear or to generate headlines.
Biotech and Internet stocks tumbled again Thursday, and the broader market followed. After a two-day respite, investors again started dumping shares of cutting-edge drug companies and other industries that have soared over the past year.
Maine's severe restrictions on opioid painkillers for Medicaid patients, requiring many to instead seek alternative pain management treatment for the past year, have sharply reduced the number of people obtaining highly addictive medications blamed for drug abuse and deaths around the nation.