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Government Agencies FDA

  • WASHINGTON, June 21- The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from "gaming" the system to block or delay entry of generic rivals. FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA rules to place...

  • *Shares up 1.5 percent in London trading. The U.S. Food and Drug Administration green light for Mydayis follows good results for Shire's new hereditary angioedema drug and helps offset the setback of early generic competition to a Shire drug for ulcerative colitis. Shares in Dublin- based Shire rose 1.5 percent by 0800 GMT in London on Wednesday following the...

  • June 20- The U.S. Food and Drug Administration on Tuesday approved Shire Plc's long-acting therapy for attention deficit hyperactivity disorder, adding another treatment to its stock of drugs for the cognitive condition that affects millions of children. Dublin- based Shire's Adderall XR, which manages symptoms for up to 12 hours, is available in generic...

  • A pharmacy technician fills a prescription inside a Wal-Mart store in Trevose, Pa.

    Donald Trump plans to make good on drug pricing promises, but any action may be weeks away.

  • June 19- The U.S. Food and Drug Administration on Monday approved a new treatment for patients with acute bacterial skin infections, made by privately held Melinta Therapeutics. The drug, Baxdela, or delafloxacin, is designed to treat skin and skin structure infections caused by a range of bacteria, including methicillin-resistant staphylococcus aureus, or...

  • Shares of Seattle Genetics fell 14 percent to $55.50 in premarket trading. In December, the U.S. Food and Drug Administration had imposed a clinical hold on several early-stage studies testing vadastuximab talirine after six AML patients were identified with liver toxicity and four died. Seattle Genetics said it would consult the FDA regarding future plans...

  • June 19- Positive data on Clovis Oncology Inc's ovarian cancer drug, Rubraca, from a late-stage study could help the U.S. biotech widen the use of the therapy and differentiate it against rivals, the company said on Monday. Rubraca was granted accelerated approval last December by the U.S. Food and Drug Administration in patients whose cancer tested positive for...

  • June 19- Clovis Oncology Inc said its ovarian cancer drug Rubraca slowed disease progression in patients who had undergone initial treatment in a late-stage trial, paving the way for expanding the use of the therapy. Rubraca was granted accelerated approval last December by the U.S. Food and Drug Administration in patients whose cancer tested positive for...

  • June 19- Clovis Oncology Inc said its ovarian cancer drug Rubraca slowed disease progression in a late-stage trial involving patients with various gene mutations who had undergone initial therapy. The U.S. Food and Drug Administration last December granted Rubraca accelerated approval in patients whose tumors have a mutation called BRCA, and whose...

  • Adamis said the Food and Drug Administration also approved the brand name Symjepi. Mylan has faced severe criticism and congressional and legal investigations after it doubled the cost for a pair of EpiPens to $600, enraging consumers. "With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a...

  • Adamis said the Food and Drug Administration also approved the brand name Symjepi. "With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail and non-retail sectors of the epinephrine market," Adamis Chief Executive Dennis Carlo said in a statement.

  • Health-care reform should include 'faster' FDA on drug approvals: David Ricks

    CNBC's Meg Tirrell talks to David Ricks, CEO of Eli Lilly, about health-care reform live from the Piper Jaffray Heartland Summit.

  • June 14- Israel- based RedHill Biopharma Ltd said its experimental drug for the treatment of gastroenteritis met the main goal in a late-stage study. RedHill is still analyzing the dataset and plans to discuss the path to approval with the Food and Drug Administration, it added on Wednesday. Gastroenteritis is a very common illness in the United States, with...

  • PARIS, June 14- Sanofi announced plans to invest 600 million euros annually over the next two to three years in the field of biologics production, an area of strong growth potential. In March, the U.S. Food and Drug Administration approved Regeneron Pharmaceuticals and Sanofi's biologic drug for eczema, Dupixent, that will sell for a list price of $37,000 a year.

  • *FDA does not ask Coherus for additional trial. June 12- Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration declined to approve its biosimilar copy of Amgen Inc's blockbuster treatment, Neulasta, which is used to fight infections in cancer patients. The FDA last year declined to approve Novartis AG's copycat for Neulasta, while its...

  • *FDA does not ask Coherus for additional trial. June 12- Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration declined to approve its biosimilar copy of Amgen Inc's blockbuster treatment, Neulasta, which is used to fight infections in cancer patients. The FDA last year declined to approve Novartis AG's copycat for Neulasta, while its...

  • *FDA does not ask Coherus for additional trial. June 12- Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration did not approve its biosimilar version of Amgen Inc's blockbuster treatment, Neulasta, which fights infections in cancer patients. The FDA last year declined to approve Novartis AG's biosimilar copy of Neulasta, while Mylan NV and...

  • June 12- Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration denied the approval of its biosimilar for Amgen Inc's blockbuster treatment, Neulasta, which fights infections in cancer patients. The FDA's response comes as Amgen gears up for biosimilar competition for Neulasta, which generated about $4.6 billion in sales last year.

  • June 12- Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration denied the approval of its biosimilar for Amgen Inc's Neulasta, which fights infections in cancer patients.

  • WASHINGTON, June 8- The U.S. Food and Drug Administration said on Thursday it has asked Endo International Plc to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company's shares down more than 12 percent. Opioids were involved in more than 33,000 deaths in 2015 and opioid overdoses have quadrupled since 1999, according to the...