Science and Enterprise

Tag: FDA

  • FDA Approves Type 2 Diabetes Drug, Orders More Studies

    The U.S. Food and Drug Administration approved on Friday the drug canagliflozin, taken in tablet form to improve control of blood glucose by adults with type 2 diabetes. Canagliflozin is marketed under the name Invokana by Janssen Pharmaceuticals Inc. in Raritan, New Jersey, a division of Johnson & Johnson. Mary Parks, who directs FDA’s metabolism…

  • Accelerator Offers Mobile Medical App Regulatory Guide

    Rock Health, a health care start-up accelerator in San Francisco, prepared an online guide to help developers of medical apps for mobile devices better understand the Food and Drug Administration’s review processes. The guide is written as an online slide presentation, viewable below and available through SlideShare. The need for the guide is growing, says…

  • Review: Energy Drinks Pose Hypertension, Heart Rhythm Risks

    A review of recent studies indicates consuming energy drinks with added caffeine can lead to heart rhythm disturbances and higher blood pressure. The team led by University of the Pacific pharmacologist Sachin Shah, presented its findings yesterday at a meeting of the American Heart Association in New Orleans. Shah, with colleagues from David Grant Medical…

  • Tests Show Many Laser Pointers Giving Off Excessive Power

    In tests by researchers at National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland, many laser pointers on the market, including most pointers with a green beam, emitted more power than allowed by federal regulations. The team led by Joshua Hadler, NIST’s laser safety officer, reported on the tests today at the International Laser…

  • Symbols and Calorie Labels Influence Restaurant Choices

    Economists at University of Illinois in Urbana and Oklahoma State University in Stillwater found the combination of calorie counts and stoplight symbols had the most influence on choices made by restaurant diners. The team led by Illinois’s Brenna Ellison (pictured right) published its findings in a recent issue of the International Journal of Behavioral Nutrition…

  • Mylan Acquires Generic Injectables Manufacturer for $1.6B

    Mylan Inc., a producer of generic and specialty branded drugs in Pittsburgh, will acquire Agila Specialties in Bangalore, India, a developer of generic inectable drugs and division of Strides Arcolab Ltd. Mylan will pay $1.6 billion cash for Agila Specialties, with up to $250 million in contingent payments possible later on. Mylan offers some 1,100…

  • Pharmas Recall Anemia Drug for Dialysis Patients

    Affymax Inc. in Palo Alto, California and Takeda Pharmaceuticals Company in Osaka, Japan are recalling its drug Omontys in the U.S. after reported cases of anaphylaxis, a serious and life-threatening allergic reaction. The recall is being coordinated with the U.S. Food and Drug Administration. Omontys, the branded form of the drug peginesatide, is a synthetic…

  • Merck, Samsung to Collaborate on Biosimilars

    The pharmaceutical company Merck & Co. in New Jersey and Samsung Bioepis Co. in Seoul, South Korea agreed on a deal for licensing and taking to market non-branded biologic therapies called biosimilars. While the companies released an outline of the financial arrangements, the dollar amount of the agreement was not disclosed. Biosimilars are treatments and…

  • Roche, Biotech to Partner on Growth Hormone Disorders

    The Swiss pharmaceutical company Roche will license a compound developed by biotechnology company Chiasma Inc., based in New York and Jerusalem, to treat the hormonal disease acromegaly and neuroendocrine tumors. The deal has a total potential value to Chiasma of $595 million. Chiasma develops drugs for oral administration previously available in injection form. The company’s…

  • Challenge Seeks Discontinued Drugs to Treat Rare Diseases

    A new challenge on InnoCentive asks for ideas on repurposing drugs no longer in development as therapies for rare diseases other than cancer. The sponsor of the competition, an unnamed biopharmaceutical company, will award a total purse of $10,000 to the best proposals. The deadline for submissions is 11 March 2013 (free registration required). Rare…