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  • A preliminary FDA review of Nesina, or alogliptin, showed a numerical increase in heart failure hospitalizations but not a statistically significant increase. Even so, some analysts expect the FDA to treat all drugs in the class the same way. "We believe the FDA will likely view the risk as likely to be a class effect and apply changes to all approved drugs in the...

  • WASHINGTON, April 14- AstraZeneca Plc's diabetes drug Onglyza should include new safety information about the risk of heart failure, a U.S. Food and Drug Administration advisory panel concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory panels but typically does so. A preliminary FDA review of the drug published on Friday noted an...

  • WASHINGTON, April 14- AstraZeneca Plc's diabetes drug Onglyza should include new safety information about the risk of heart failure, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted overwhelmingly that the drug's label should be changed to add information about an increased heart failure risk, but did not...

  • April 13- An intravenous blood clot preventer developed by The Medicines Co should be approved by the U.S. Food and Drug Administration, FDA staff reviewers concluded. The FDA rejected the blood thinner in April last year, after its reviewers took issue with the way a pivotal trial, called Champion- Phoenix, was conducted, and asked the company to reanalyze its...

  • CHICAGO, April 10- Sales of human antibiotics in the United States for use in livestock jumped by 20 percent between 2009 and 2013, federal regulators said on Friday, although recent statements by producers suggest those figures could be dropping. Companies such as Tyson Foods Inc and Perdue Farms have said in the past year, however, they have either reduced or...

  • April 10- Swedish Match AB should not be allowed to alter the warning label on its snus smokeless tobacco products to claim they are less harmful than cigarettes, an advisory panel to the U.S. Food and Drug Administration concluded on Friday. Stockholm- based Swedish Match is seeking FDA approval to remove warnings about mouth cancer, gum disease and tooth loss...

  • April 10- Swedish Match AB should not be allowed to alter the warning label on its snus smokeless tobacco products to claim they are less harmful than cigarettes, an advisory panel to the U.S. Food and Drug Administration concluded on Friday.

  • CHICAGO, April 10- Sales of medically important antibiotics in the United States for use in livestock jumped by 20 percent between 2009 and 2013, federal regulators reported on Friday, data that is sure to fuel concern that bacteria infecting humans could grow more resistant to the drugs. The U.S. Food and Drug Administration reported that domestic sales and...

  • U.S. meat industry buying more human antibiotics -FDA Friday, 10 Apr 2015 | 11:39 AM ET

    CHICAGO, April 10- Sales of medically important antibiotics in the United States for use in livestock jumped by 20 percent between 2009 and 2013, federal regulators reported on Friday, data that is sure to feed the national debate about the growth of drug-resistant bacteria. The U.S. Food and Drug Administration reported that domestic sales and distribution...

  • April 10- AstraZeneca Plc's diabetes drug Onglyza may be associated with an increased rate of death, according to a preliminary review of data by the U.S. Food and Drug Administration. The FDA's report, posted on the agency's website on Friday, comes ahead of an April 14 meeting of an FDA advisory panel to discuss the drug's safety. The FDA said the causes of death...

  • Britain's FTSE nears record high as Shire shines Friday, 10 Apr 2015 | 9:11 AM ET

    *FTSE 100 up 0.5 pct, near record highs. The FTSE 100 rose 0.5 percent to 7,051.07 points, close to a record 7,065.08 points reached in March. Shire shares rose 5.2 percent, the biggest gain on the FTSE 100, from a U.S. Food and Drug Administration decision to grant a priority review to its application for lifitegrast, a dry-eye disease treatment.

  • FDA stayed silent on hazardous diet pills: Report Wednesday, 8 Apr 2015 | 11:50 AM ET
    A Vitamin Shoppe store in New York.

    FDA never publicized that popular supplements contain a chemical nearly identical to amphetamine. New York Times reports.

  • April 7- Denmark's Novo Nordisk A/S said the U.S. Food and Drug Administration accepted a resubmitted application for its key insulin drug, Tresiba, based on interim analysis data from a clinical trial. Tresiba, already available outside the United States, was rebuffed by the FDA two years ago on concerns that the drug could be linked to higher rates of heart...

  • April 7- Denmark's Novo Nordisk said the U.S. Food and Drug Administration accepted a resubmitted application for its insulin drug, Tresiba.

  • April 7- Hospira Inc, which agreed in February to be bought by Pfizer Inc, said the U.S. Food and Drug Administration had sent it another warning letter detailing violations in standard drug manufacturing practices at one of its facilities. Hospira's response to the FDA's concerns lacked "sufficient corrective actions", the agency said. However, the FDA warned in...

  • WASHINGTON, April 7- The U.S. Food and Drug Administration said on Tuesday it is concerned that a Swedish Match AB proposal to soften warnings on its snus smokeless tobacco products would not accurately reflect the risks associated with snus use. Stockholm- based Swedish Match is seeking FDA approval of language stating that its snus products are less risky...

  • Hospira gets FDA warning letter for Italian facility Tuesday, 7 Apr 2015 | 11:12 AM ET

    April 7- Hospira Inc, which agreed in February to be acquired by Pfizer Inc, said it received a warning letter from the U.S. Food and Drug Administration related to its manufacturing facility in Liscate, Italy.

  • April 6- Ocular Therapeutix Inc said its lead eye drug failed to meet one of the main goals in a second late-stage study. Both endpoints needed to be met for the trial to be considered successful, Ocular Therapeutix said. The company said it plans to meet the U.S. Food and Drug Administration to discuss the trial results.

  • Online breast milk may not be 100% human milk Monday, 6 Apr 2015 | 10:20 AM ET
    A previous study conducted by Nationwide Children's Hospital found that of the 102 samples they bought and tested, 75 percent were contaminated with disease-causing bacteria.

    NBC News reports on a study that finds some breast milk sold online actually contains cow's milk.

  • WASHINGTON, April 2- In a decision that could reshape U.S. tobacco regulation, a health advisory panel will vote next week on whether Swedish Match AB, a Stockholm- based maker of smokeless tobacco products known as snus, can claim they are less harmful than cigarettes. The closely watched vote could pave the way for the first Food and Drug Administration approval...