Government Agencies FDA

  • The committee, which convened to advise the FDA on whether to approve the drug, voted unanimously that the treatment has no more effect on the disease than a placebo over a two-year period. The FDA is not obliged to follow the advice of its advisory committees but typically does so. The company subsequently initiated a new late-stage trial which it said...

  • The FDA confirmed on Wednesday that Dr. Farkas was seen as the leading voice within the FDA arguing against the approval of the drug and the author of a scathing critique of the company's application. Suntrust Robinson Humphrey said Farkas's departure at this juncture would further indicate that there is turmoil within the FDA on what to do with eteplirsen.

  • Heather Bresch, CEO Mylan

    Mylan CEO Heather Bresch will appear at a Sept. 21 congressional hearing over price increases of EpiPen.

  • Mylan CEO Heather Bresch and an official from the Food and Drug Administration will testify before the House Oversight and Government Reform Committee. Jason Chaffetz of Utah, and the top Democrat, Rep. Elijah Cummings of Maryland, said they also will examine ways to encourage greater competition in the EpiPen market.

  • Sept 14- Shire Plc said the United States Food and Drug Administration approved its treatment for patients with primary immunodeficiency, a group of genetic disorders in which part of the body's immune system is missing or functions improperly.

  • The FDA staff, in a preliminary review, expressed concerns about the collection and interpretation of data from a post-marketing study on the controversial drug. In March 2015, the FDA left the warning on the label, following the recommendation of an advisory committee to wait for the outcome of the study in more than 8,000 adult smokers. However, FDA staff...

  • The FDA staff, in a preliminary review, expressed concerns about the collection and interpretation of data from a post-marketing study on the controversial drug. In March 2015, the FDA left the warning on the label, following the recommendation of an advisory committee to wait for the outcome of the study in more than 8,000 adult smokers. However, FDA staff...

  • Last year, the FDA decided to keep the black box warning on the label, following the recommendation of an advisory committee in October 2014 to wait for the outcome of the additional study. However, FDA staff has disputed the results, saying the interview methodology may have been inadequate in capturing the nuances of severe neuropsychiatric side-effects.

  • Sept 12- U.S. Food and Drug Administration scientists have expressed concerns about a post-marketing study of Pfizer Inc's drug Chantix, which is aimed at helping smokers quit, according to documents posted on the regulator's website on Monday. The concerns are related to the trial design and data interpretation of the study, called Eagles, in more than 8,000...

  • The Israeli drugmaker, in a webcast overview of its generics medicines business, said it plans to meet with the U.S. Food and Drug Administration about potentially re-submitting Teva's U.S. marketing application for the device. The FDA in February declined to approve the product, citing dosage problems. Sigurdur Olafsson, Teva's head of global generic...

  • WASHINGTON, Sept 8- On April 5, 2012, a criminal investigator from the Food and Drug Administration named Robert West charged into an oncology clinic in Greenville, Tennessee. West told Posey Sen she was guilty of buying counterfeit drugs and looked like a "deer in the headlights," court records say. Earlier that year, managers at the FDA's Maryland- based Office of...

  • WASHINGTON, Sept 8- On April 5, 2012, a criminal investigator from the Food and Drug Administration named Robert West charged into an oncology clinic in Greenville, Tennessee. West told Posey Sen she was guilty of buying counterfeit drugs and looked like a "deer in the headlights," court records say. Earlier that year, managers at the FDA's Maryland- based Office of...

  • A scientist at Gilead Sciences analyzes patient antibody levels at the Gilead laboratory in Foster City, Calif.

    Gilead Sciences rose Tuesday after it was upgraded, citing confidence in the prospects for Gilead's HIV treatments among other factors.

  • Sept 6- Tonix Pharmaceuticals Holding Corp said it would stop developing its drug for fibromyalgia and focus on a late-stage trial testing the treatment in patients with post-traumatic stress disorder. If the drug succeeds in a late-stage trial in PTSD patients and is approved by the U.S. Food and Drug Administration, it would be the first new treatment for the...

  • Theresa Michele, director of the FDA's division of nonprescription drug products, told reporters on a conference call. FDA spokeswoman Andrea Fischer and Brian Sansoni, of the American Cleaning Institute, which represents multiple cleaning products companies, were unable to identify the products most affected by Friday's ruling. The FDA had proposed...

  • Theresa Michele, director of the FDA's division of nonprescription drug products, told reporters on a conference call. "A small quantity of our bar soap in Puerto Rico, where FDA rules also apply, is being reformulated," he said. The American Cleaning Institute, which represents cleaning products companies, including Dial Corp, a unit of Germany's Henkel, Ecolab Inc...

  • The FDA deferred by a year its ruling on three additional ingredients used in consumer wash products- benzalkonium chloride, benzethonium chloride and chloroxylenol- to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be sold...

  • Sept 2- The U.S. Food and Drug Administration on Friday halted the sale of some antibacterial over-the-counter hand and body wash products, saying they were not more effective than plain soap and water in preventing illnesses and reducing the spread of infections. The ruling applies to products containing one or more of 19 ingredients, including triclosan and...

  • NEW YORK, Sept 1- Teva Pharmaceutical Industries on Thursday lost a third patent for its top-selling multiple sclerosis treatment as U.S. patent officials ruled that Copaxone did not deserve legal protection, bringing rivals one step closer toward selling generic versions. According to U.S. Food and Drug Administration data, Copaxone had been protected by...

  • NEW YORK, Sept 1- U.S. patent officials on Thursday invalidated a third patent for Teva Pharmaceutical Industries' $4 billion multiple sclerosis treatment Copaxone, saying it did not deserve legal protection, after cancelling two other patents on the drug last week. According to U.S. Food and Drug Administration data, Copaxone had been protected by five patents...