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  • Dec 22- The U.S. Food and Drug Administration approved Bristol-Myers Squibb Co's skin cancer drug, more than three months before the scheduled review date. The drug is the second PD-1 inhibitor to be approved by the FDA, the first being Merck& Co Inc's Keytruda in September. The FDA was scheduled to review the drug on March 30.

  • FDA approves Bristol-Myer's skin cancer drug Monday, 22 Dec 2014 | 2:32 PM ET

    Dec 22- The U.S. Food and Drug Administration granted an accelerated approval to Bristol-Myers Squibb Co's drug for an advanced form of skin cancer. The drug, Opdivo, inhibits the action of the protein PD-1, which prevents the body's immune system from attacking melanoma tumors. The FDA's approval comes well before its scheduled review date of March 30.

  • Dec 22- The U.S. Food and Drug Administration approved Biocryst Pharmaceuticals Inc's intravenous flu drug, sending the company's shares up nearly 10 percent in premarket trading. The single-dose drug is for adults who have acute uncomplicated influenza and may be unable to swallow pills, such as Gilead Sciences Inc's Tamiflu, or inhale GlaxoSmithKline...

  • FDA approves BioCryst's flu shot Monday, 22 Dec 2014 | 5:04 AM ET

    Dec 22- The U.S. Food and Drug Administration approved Biocryst Pharmaceuticals Inc's single-dose flu shot on Monday, for use in adults with acute uncomplicated influenza. The drug was developed under a $234.8 million contract from Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services.

  • Dec 19- U.S. health regulators on Friday approved AbbVie's all-oral treatment for hepatitis C, and the company said the drug would cost $83,319 for a typical 12- week plan, a bit below its huge selling competitor Solvadi from Gilead Sciences. AbbVie's newly approved regimen is also less costly than Gilead's newest one-pill regimen that combines Sovaldi with...

  • Dec 19- U.S. health regulators on Friday approved AbbVie's all-oral treatment for hepatitis C, providing the first competition for Gilead Sciences huge selling and expensive medicine for the liver-destroying virus. The AbbVie regimen consists of four different anti-viral drugs to be taken as three pills in the morning and one in the evening.

  • Dec 19- AstraZeneca Plc's ovarian cancer drug has been granted an accelerated approval by the U.S. health regulator, a day after it was approved by the European Commission. An advisory panel to the U.S. Food and Drug Administration had voted in June against granting an accelerated approval to the drug, Lynparza, citing inadequate data. Lynparza aims to treat...

  • US STOCKS-Futures edge higher after two-day rally Friday, 19 Dec 2014 | 7:34 AM ET

    *Brent edges above $60 a barrel. *Brent crude oil rose above $60 a barrel on Friday, recovering from near a 5-1/ 2- year low while WTI crude advanced 1.7 percent to $55.02. *Cerus Corp shares jumped 13.6 percent to $7 before the opening bell after the company said the U.S. Food and Drug Administration approved its blood transfusion device for platelets.

  • UPDATE 1-Pozen says FDA rejects lead drug again Wednesday, 17 Dec 2014 | 8:18 AM ET

    Dec 17- Pozen Inc said two versions of its experimental heart drug were rejected for the second time by the U.S. Food and Drug Administration, which again cited deficiencies in the manufacturing plant of a supplier of an active ingredient. Pozen's shares fell nearly 23 percent to $6.99 in premarket trading on Wednesday. Pozen, which first received the rejection...

  • Dec 17- Pozen Inc said two versions of its experimental heart drug were rejected for the second time by the U.S. Food and Drug Administration, which cited deficiencies in the manufacturing plant of a supplier of an active ingredient. Pozen's shares fell 19 percent to $7.30 in premarket trading on Wednesday. The two drugs, PA8140 and PA32540, are being evaluated for...

  • Dec 16- Salix Pharmaceuticals Ltd said it would clear excess inventory by the end of 2015, a year earlier than it had forecast, sending its shares up about 6 percent premarket. The company forecast a profit of $3.10- $4.10 per share on total net product revenue of $1.25- $1.35 billion for 2015.. Salix also said the U.S. Food and Drug Administration has delayed a...

  • Salix to fix inventory pile-up by end of 2015 Tuesday, 16 Dec 2014 | 7:25 AM ET

    Dec 16- Salix Pharmaceuticals Ltd said it would cut sales to wholesalers to fix an inventory issue related to three key drugs, and withdrew its forecast for the fourth quarter. The company said it expects to fix the inventory issue by the end of 2015.. Salix also said the U.S. Food and Drug Administration has delayed a decision on the extended approval of Salix's...

  • Dec 11- Pfizer Inc's antipsychotic Geodon and generic versions of the drug can trigger a potentially fatal skin reaction, the U.S. Food and Drug Administration warned on Thursday. A new warning has been added to the drug's label to describe the condition- known as Drug Reaction with Eosinophilia and Systemic Symptoms- which may start as a rash and spread all over.

  • Arca's potential Ebola drug gets "orphan drug status" Wednesday, 10 Dec 2014 | 11:19 AM ET

    Dec 10- Arca Biopharma Inc said the U.S. Food and Drug Administration granted its experimental drug orphan drug status as a potential treatment for viral hemorrhagic fever after exposure to the Ebola virus. The Westminster, Colorado- based company, whose stock rose about 11 percent on Wednesday, joins a list of drugmakers looking for ways to fight the largest...

  • LONDON, Dec 10- Drugmakers are finally getting more bang for their scientific buck, with the rate of return on pharmaceutical research and development increasing for the first time since 2010.. So far this year the U.S. Food and Drug Administration, which acts as gatekeeper to the world's biggest market, has approved 35 new products, up from 27 in the whole of 2013...

  • Dec 8- Medical device maker Stryker Corp will pay the U.S. government $80 million to settle criminal and civil charges that its OtisMed Corp subsidiary sold devices used in knee replacement surgery without approval from the U.S. Food and Drug Administration. The company sold more than 18,000 OtisKnee cutting guides- which are designed to help surgeons make...

  • Dec 8- Medical device maker Stryker Corp will pay the U.S. government $80 million to settle charges that its OtisMed Corp subsidiary sold devices used in knee replacement surgery without approval from the U.S. Food and Drug Administration. The company sold more than 18,000 OtisKnee cutting guides- which are designed to help surgeons make accurate bone cuts in...

  • NEW YORK, Dec 8- U.S. health regulators estimate that consumers will suffer up to $5.27 billion in "lost pleasure" over 20 years when calorie counts on restaurant menus discourage people from ordering french fries, brownies and other high-calorie favorites. The FDA said the analysis balances the benefits to consumers when calorie information leads them to eat...

  • Dec 3- U.S. health regulators on Wednesday approved an Amgen Inc drug that helps the immune system fight a rare type of leukemia, more than five months ahead of the expected decision date. Anthony Stein, professor of hematology at City of Hope outside Los Angeles who worked on clinical trials of blinatumomab, called the approval "very important" for patients.

  • Dec 2- The U.S. Food and Drug Administration changed the rules governing how prescription drugs and biologics used during pregnancy and breastfeeding are labeled. The decision, which has been in the works since 2008, will impact more than 6 million pregnancies in the United States involving women who, on average, need to take three to five prescription drugs...