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  • Feb 17- Israel's VBL Therapeutics Inc said it would stop developing its experimental inflammatory drug to fight ulcerative colitis and psoriasis, sending its shares tumbling 45 percent before the bell. Separately, the biotechnology company said the U.S. Food and Drug Administration lifted a partial hold on another drug that is being tested to treat an...

  • FDA lifts hold on VBL's lead drug Tuesday, 17 Feb 2015 | 7:54 AM ET

    Feb 17- Israel's VBL Therapeutics Inc said the U.S. Food and Drug Administration lifted a partial hold on its experimental drug to treat an aggressive form of brain cancer. The drug, VB-111, is being evaluated in a late-stage study for use in recurrent glioblastoma. The hold was imposed by the agency in July, pending additional data.

  • Supporters of Sprout's drug say women's sexual disorders have been overlooked for too long by regulators at the Food and Drug Administration. But the Food and Drug Administration has already twice rejected the drug because of lackluster effectiveness and side effects including fatigue, dizziness and nausea. "Women deserve equal treatment when it comes to...

  • UPDATE 1-FDA approves Eisai's thyroid cancer drug Friday, 13 Feb 2015 | 10:34 AM ET

    Feb 13- The U.S. Food and Drug Administration said it approved Japan's Eisai Co Ltd's drug to treat the most common form of thyroid cancer more than two months ahead of the review date. The FDA was slated to make a decision on Lenvima by April 14. Lenvima will be sold in the United States by Woodcliff Lake, New Jersey- based Eisai Inc, a unit of Tokyo- based Eisai.

  • FDA approves Eisai's thyroid cancer drug Friday, 13 Feb 2015 | 10:04 AM ET

    Feb 13- The U.S. Food and Drug Administration said it approved Japan's Eisai Co Ltd's drug to treat the most common form of thyroid cancer. The drug, Lenvima, was cleared for use in patients with progressive, differentiated thyroid cancer who have not adequately responded to radioactive iodine therapy, the FDA said in a statement. DTC is a cancerous growth of the...

  • Hamburg, 59, is one of the longest-serving FDA commissioners in the modern era. In a note to staff, Hamburg said it was "with very mixed emotions" that she planned to step down at the end of March and that her tenure as FDA chief "has been the most rewarding of my career." Stephen Ostroff, the FDA's chief scientist, will fill Hamburg's position until a new commissioner is...

  • FDA spokeswoman Stephanie Yao declined to comment. Hamburg, 59, is one of the longest-serving FDA commissioners in the modern era. Stephen Ostroff, the FDA's chief scientist, will fill Hamburg's position until a new commissioner is named, said a second person familiar with the matter.

  • FOOD AND DRUG ADMINISTRATION COMMISSIONER MARGARET HAMBURG TO STEP DOWN-SOURCE.

  • Feb 4- The U.S. Food and Drug Administration has approved Cohera Medical Inc's tissue adhesive for internal use during surgery, the first approval of its kind. The product, TissuGlu, is used to connect flaps of tissue made during surgery to remove excess fat and skin or to restore weakened or separated abdominal muscles. Using the synthetic adhesive will help...

  • Feb 3- The U.S. Food and Drug Administration on Tuesday said it had approved Pfizer Inc's experimental breast cancer drug Ibrance, a regulatory decision that came more than two months earlier than expected. Wall Street has considered the drug, whose chemical name is palbociclib, to be one of the most promising medicines in Pfizer's development pipeline.

  • HHS wants power to negotiate specialty drug prices Monday, 2 Feb 2015 | 4:25 PM ET
    U.S. Secretary of Health and Human Services Sylvia Burwell.

    The $1.08 trillion budget sought by federal health officials includes a request they be able to negotiate some drug prices for Medicare.

  • Feb 2- The U.S. Food and Drug Administration approved a drug developed by Eli Lilly and Co and Boehringer Ingelheim Pharmaceuticals Inc to improve blood sugar control in type-2 diabetes patients, the companies said. "Half of people with type-2 diabetes do not achieve recommended blood sugar control, making new treatment options more important than ever," Eli...

  • Feb 2- The U.S. Food and Drug Administration approved a drug developed by Eli Lilly and Co and privately held Boehringer Ingelheim Pharmaceuticals Inc to improve blood sugar control in type-2 diabetes patients, the companies said.

  • Feb 2- The U.S. Food and Drug Administration has designated BlueBird Bio Inc's blood disorder drug a breakthrough therapy, speeding up the treatment's development process. The company's shares rose nearly 7 percent in premarket trading. Breakthrough therapy designation is based on initial trial data and granted to drugs with the potential to treat serious...

  • Obama seeks $215 million for 'precision medicine' Friday, 30 Jan 2015 | 6:00 AM ET
    President Barack Obama delivers the State of the Union address on January 20, 2015 in the House Chamber of the U.S. Capitol in Washington.

    President Obama will dedicate $215 million in his budget request to a program that will target the underlying cause of disease.

  • UPDATE 1-U.S. FDA approves Bristol-Myers, J&J HIV pills Thursday, 29 Jan 2015 | 6:35 PM ET

    Jan 29- The U.S. Food and Drug Administration on Thursday approved two fixed-dose HIV pills that combine protease inhibitors- one made by Bristol-Myers Squibb Co and the other by Johnson& Johnson- both with a boosting agent produced by Gilead Sciences Inc.. Bristol-Myers said its drug, Evotaz, is a once-daily pill containing Reyataz, also known as atazanavir, a...

  • U.S. FDA approves Bristol-Myers' HIV drug Thursday, 29 Jan 2015 | 5:44 PM ET

    Jan 29- The U.S. Food and Drug Administration has approved the sale of Evotaz, a once-daily combination pill to treat HIV made by Bristol-Myers Squibb Co, the company said on Thursday. The new drug combines Reyataz, also known as atazanavir, a Bristol-Myers' protease inhibitor, with cobicistat, a boosting agent produced by Gilead Sciences Inc..

  • The regulator's decision, which comes in over two months ahead of its review date, represents a fourth indication for the drug, sold by Johnson& Johnson and Pharmacyclics Inc. Although WM occurs only in up to 1,500 patients in the United States each year, the approval highlights the strength of the Imbruvica franchise, Roth Capital Partner's Joseph Pantginis...

  • FDA expands use of Imbruvica to treat rare form of cancer Thursday, 29 Jan 2015 | 11:29 AM ET

    Jan 29- The U.S. Food and Drug Administration said it cleared an expanded use of Imbruvica to treat Waldenström's macroglobulinemia, a rare form of cancer that begins in the body's immune system. The approval represents a fourth indication for the drug, sold by Johnson& Johnson and Pharmacyclics Inc, since its initial approval in November 2013.

  • WASHINGTON, Jan 28- U.S. lawmakers proposed a bill on Wednesday that would create a single food safety agency by bringing together the oversight functions of the Food and Drug Administration, U.S. Department of Agriculture and other agencies. Democratic Senator Richard Durbin from Illinois and Representative Rosa DeLauro, a Democrat from Connecticut, told...