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Government Agencies FDA

  • Aug 17- The U.S. Food and Drug Administration on Thursday expanded the use of Lynparza, sold by AstraZeneca Plc and Merck& Co Inc, to include ongoing treatment of patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. The agency also approved a new two-tablet regimen for the drug, regardless of whether patients test positive...

  • Emulate chip

    This emerging biotech movement promises to radically overhaul the arduous process of bringing new drugs, foods and cosmetics to market.

  • Aug 10- Perrigo Co Plc's shares surged as much as 20.4 percent on Thursday after the drugmaker surprised Wall Street with strong quarterly generic drug sales due to new product launches and raised its full-year adjusted profit forecast. The business of selling generic drugs in the United States has suffered as the Food and Drug Administration expedites the...

  • An Impossible Burger, which resembles meat but is made of plant products, on the grill in the company’s lab in Redwood City, Calif., Dec. 23, 2016.

    Impossible Foods wants the Food and Drug Administration to confirm that the ingredient is safe to eat, N.Y. Times reports.

  • WASHINGTON, Aug 8- Hot on the heels of its proposal to lower nicotine levels in cigarettes, the U.S. Food and Drug Administration announced plans on Tuesday for an education campaign to discourage use of electronic cigarettes among youth. Its new policy "aims to strike a careful balance between the regulation of all tobacco products, and the opportunity to...

  • Aug 8- Hot on the heels of its proposal to lower nicotine levels in cigarettes, the U.S. Food and Drug Administration on Tuesday announced plans for an education campaign to discourage use of electronic cigarettes among youth. Its new policy "aims to strike a careful balance between the regulation of all tobacco products, and the opportunity to encourage...

  • LONDON, Aug 7- Investors are betting on a little-known biotech company to supply Big Tobacco with low-nicotine cigarettes, but so far its technology is unproven. Shares in New York- based 22nd Century Group have soared 80 percent to a three-year high since late last month, when the U.S. Food and Drug Administration proposed cutting the nicotine levels in...

  • Sickle cell disease is a lifelong disorder in which red blood cells, normally round, are crescent- (or sickle-) shaped, due to abnormal hemoglobin. This can impede blood flow.

    Emmaus Medical CEO Dr. Yutaka Niihara spent much of his career developing Endari, a recently approved FDA drug to treat sickle cell anemia.

  • Aug 3- The U.S. Food and Drug Administration on Thursday approved AbbVie Inc's drug to treat certain adults with chronic hepatitis C. Mavyret is the only 8- week duration treatment approved for all hepatitis C genotypes, the FDA said. An estimated 2.7 million to 3.9 million people in the United States have chronic hepatitis C infection, according to the Centers...

  • 2 factors driving the generics market: Wells Fargo Securities' David Maris

    David Maris, Wells Fargo Securities, discusses the outlook for generic drug companies in the pharmaceutical sector.

  • Aug 3- The U.S. Senate on Thursday passed a bill allowing the Food and Drug Administration to continue collecting fees from drug companies to review new product applications. The Senate passed the bill by a vote of 94-1.. Separately, the Senate passed a so-called right-to-try bill designed to allow terminally ill patients access to unapproved medications and...

  • U.S. SENATE VOTES 94-1 TO RENEW LAW ALLOWING FOOD AND DRUG ADMINISTRATION TO COLLECT FEES FROM DRUG COMPANIES.

  • *Idhifa to have monthly list price of $24,872. Aug 1- The U.S. Food and Drug Administration on Tuesday approved Celgene Corp and Agios Pharmaceuticals Inc's oral treatment for acute myeloid leukemia patients with a rare genetic mutation. The drug, Idhifa, will have a monthly list price of $24,872, Celgene said in an email, noting that the median time on therapy for...

  • July 31- There were more deaths in patients taking Johnson& Johnson's experimental rheumatoid arthritis drug sirukumab than among those taking a placebo, staff reviewers for the U.S. Food and Drug Administration said in a report published Monday. The FDA is not obliged to follow the advice of its advisers but typically does so. It was published on the FDA's...

  • July 31- There were more deaths in patients taking Johnson& Johnson's experimental rheumatoid arthritis drug sirukumab than among those taking a placebo, staff reviewers for the U.S. Food and Drug Administration said in a report published Monday. The FDA is not obliged to follow the advice of its advisors but typically does so. It was published on the FDA's...

  • How to contain costs in 'golden era of medicine': PhRMA CEO

    Stephen Ubl, Pharmaceutical Research and Manufacturers of America president & CEO, talks about ways to control drug prices so patients can benefit from lower costs.

  • PARIS, July 31- France's Sanofi raised its 2017 earnings forecast, citing strong second-quarter growth in consumer healthcare, vaccines and its Genzyme unit and said it was encouraged by U.S. uptake of eczema drug Dupixent. In March, the U.S. Food and Drug Administration approved Regeneron Pharmaceuticals' and Sanofi's biologic drug for atopic dermatitis- also...

  • PARIS, July 31- French drugmaker Sanofi raised its 2017 outlook on the back of strong growth at its consumer healthcare, vaccines and Genzyme arms in the second quarter, and said it was encouraged by the uptake of a key new eczema drug in the United States. In March, the U.S. Food and Drug Administration approved Regeneron Pharmaceuticals and Sanofi's biologic drug...

  • Shares of major tobacco companies in the United States and UK slumped in heavy trading volume after the proposal was unveiled by the head of the U.S. Food and Drug Administration, with the world's biggest producers losing about $26 billion of market value. The FDA cannot reduce nicotine levels to zero, nor can it ban cigarettes. But Gottlieb said the agency would...

  • FDA staffers, in a review released earlier this week, said the experimental hepatitis B vaccine is effective, but that there were more deaths and serious heart problems in patients given the vaccine than in those who took a rival product. The FDA is not bound to follow the advice of its advisory panels but typically does so. If the FDA approves the vaccine, peak sales...