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  • FDA OKs Cubist antibiotic for serious infections Friday, 19 Dec 2014 | 6:34 PM ET

    WASHINGTON, D.C.— The Food and Drug Administration has approved a new combination medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved this year. The approval of Zerbaxa is the second antibiotic approval this year for Cubist Pharmaceuticals, which agreed earlier this month to be acquired for $8.4...

  • FDA approves AbbVie combo hepatitis C treatment Friday, 19 Dec 2014 | 3:35 PM ET

    TRENTON, N.J.— Patients with chronic hepatitis C have a new option for treating the liver-damaging virus, with the approval of a combination treatment developed by AbbVie. The Food and Drug Administration on Friday approved the sale of a packaged treatment called Viekira Pak made by AbbVie Inc. of North Chicago, Illinois. It includes a combination pill, which...

  • 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.

  • AstraZeneca cancer drug, companion test approved Friday, 19 Dec 2014 | 1:24 PM ET

    TRENTON, N.J.— U.S. regulators on Friday granted accelerated approval to the first in a new class of targeted drugs for ovarian cancer, Lynparza from British drugmaker AstraZeneca PLC. The Food and Drug Administration also approved a companion diagnostic test from Myriad Genetics Inc. of Salt Lake City called BRACAnalysis CDx. Richard Pazdur, director of the...

  • 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...

  • Alcohol calorie counts to be on menus by next year Wednesday, 17 Dec 2014 | 12:54 AM ET

    WASHINGTON— Don't want to be confronted with the number of calories in that margarita or craft beer? New menu labeling rules from the Food and Drug Administration will require chain restaurants with 20 or more outlets to list the amount of calories in alcoholic drinks, along with other foods, on menus by next November. "Alcoholic beverages are a key contributor to...

  • 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...

  • FDA panel says newer HIV tests effective Tuesday, 2 Dec 2014 | 5:00 PM ET

    Dec 2- Newer methods to test donated blood samples for HIV infections are effective, a panel of experts at the U.S. Food and Drug Administration concluded, in a move that could limit the ban on donations by men who have had sex with other men. The FDA's ban, in place for about three decades, disallows donations from men who have had sex with even one man since 1977, as they...