Government Agencies FDA

  • NEW YORK, Sept 1- U.S. patent officials on Thursday invalidated a third patent covering Teva Pharmaceutical Industries' $4 billion multiple sclerosis treatment Copaxone, after cancelling two other patents on the drug last week. The ruling came in a challenge at the U.S. According to the U.S. Food and Drug Administration, Copaxone is protected by five patents in...

  • Aug 31- The U.S. Food and Drug Administration on Wednesday strengthened warnings about the danger of combining opioid painkillers or cough medicines containing opioids with benzodiazepines, a common class of sedatives. "It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used...

  • Aug 31- Blood-testing firm Theranos Inc said it voluntarily withdrew a request to the U.S. Food and Drug Administration for emergency clearance of its Zika-virus blood test. Theranos made the decision after the FDA said the company did not include proper patient safeguards in a study, the Wall Street Journal reported, citing people familiar with the matter.

  • WASHINGTON, Aug 30- The U.S. Food and Drug Administration on Tuesday approved Novartis AG's biosimilar version of Amgen Inc's arthritis drug Enbrel. The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions including rheumatoid arthritis and plaque psoriasis, a skin condition. "We are committed to bringing Erelzi...

  • Emanuel: Goverment regulation needed to keep drug prices reasonable

    Dr. Ezekiel Emanuel, University of Pennsylvania Chair of Medical Ethics & Health Policy, weighs in on the drug pricing debate in the wake of Mylan's EpiPen pricing saga.

  • Rx drug price mess

    Dr. Josh Sharfstein, Johns Hopkins University and Former FDA official, discusses the role of the FDA in drug pricing and competition in the pharmaceutical space.

  • *Locally transmitted cases in Florida are mounting. Through last week, the United States reported 2,517 Zika cases, 29 of which were likely acquired locally in Florida through mosquito bites and the rest brought in by travelers, the U.S. Centers for Disease Control and Prevention said. With FDA approval, Roche's test now can be used to screen patients exhibiting...

  • CHICAGO/ TAMPA, Fla., Aug 26- The U.S. Food and Drug Administration recommended on Friday that all blood donated in the United States and its territories be tested for Zika virus, as it moves to prevent transmission of the virus through the blood supply. The agency said its decision to expand blood screening in the United States was based on concerns about more cases...

  • CHICAGO, Aug 26- The U.S. Food and Drug Administration recommended on Friday that all blood donated in the United States and its territories be tested for Zika virus, as it moves to prevent transmission of the virus through the blood supply. The agency said its move to expand blood screening in the United States was based on concerns about increasing cases of local...

  • Aug 26- The U.S. Food and Drug Administration recommended on Friday that all blood donated in the United States and its territories be tested for Zika virus, as it moves to prevent transmission of the virus through the blood supply. The agency's move to expand its previous guideline for blood screening comes after Florida officials on Tuesday announced the...

  • The agency's move to expand its previous guideline for blood screening comes after Florida officials on Tuesday announced the first case of Zika transmitted by mosquitoes in Pinellas County, some 265 miles from Miami, where the first locally transmitted U.S. cases were reported. The FDA last month ordered blood banks in Florida's two most densely populated...

  • The agency's move to expand its previous guideline for blood screening comes after Florida officials on Tuesday announced the first case of Zika transmitted by mosquitoes in Pinellas County near Miami, where the first locally transmitted U.S. cases were reported. The FDA last month ordered blood banks in Florida's two most densely populated counties-...

  • The VC case for drug pricing

    James Thornton, venture capital investor, discusses Mylan CEO Heather Bresch's explanation for the pricing of the EpiPen. CNBC Contributor Bill George, former CEO of Medtronic, and Darnisha Harrison, Ennaid Therapeutics CEO, weigh in.

  • Ennaid CEO on cutting through the FDA's red tape

    CNBC Contributor Bill George, former CEO of Medtronic, and Darnisha Harrison, Ennaid Therapeutics CEO, discuss the controversy surrounding Mylan's pricing of the EpiPen and the FDA's guidelines for drug development.

  • Corpse toe tag

    CNBC and NBC NY found thousands of FDA safety reports where deaths were classified as less serious injuries and equipment malfunctions.

  • Aug 18- The U.S. Food and Drug Administration has widened the use of Edwards Lifesciences Corp's heart valves to patients at intermediate risk of complications if they underwent open heart surgery. The devices, Sapien XT and Sapien 3, have already been approved for use in patients unlikely to survive open-heart surgery or are at high risk for complications.

  • Increased oversight of medical devices needed?

    Medical companies are misclassifying thousand of patient fatalities as injuries. NBC's Chris Glorosio reports.

  • Intrexon CEO on Zika: We're working closely with FDA

    Intrexon CEO Randal Kirk shares his take on combating Zika.

  • Aug 10- Heron Therapeutics Inc's twice-rejected long-acting injection to prevent chemotherapy-induced nausea and vomiting was finally approved by the U.S. Food and Drug Administration, marking the biotech's first regulatory approval. The Redwood City, California- based company's shares rose as much as 21 percent to $24 on Wednesday.

  • Aug 10- Heron Therapeutics Inc's twice-rejected long-acting injection to prevent chemotherapy-induced nausea and vomiting was finally approved by the U.S. Food and Drug Administration, marking the biotech's first regulatory approval. The Redwood City, California- based company's shares were up 17 percent at $23.35 in premarket trading on Wednesday.