Biotech and Pharmaceuticals Medicine

More

  • The death of the patient with a recurrent brain tumor was announced in a single bullet point in a series of slides as part of a filing with the U.S. Securities and Exchange Commission on Thursday. On Friday morning, the biotechnology company issued a statement saying it was still collecting and analyzing data on the third death, and had not reported it to the FDA.

  • The death of the patient with a recurrent brain tumor, was revealed as part of a series of slides in a U.S. Securities and Exchange filing late on Thursday. Ziopharm was not immediately available for comment, and the company's stock tumbled about 22 percent to $4.44 in premarket trading on Friday. Earlier this week, the U.S. Food and Drug administration lifted a...

  • July 13- Researchers have for the first time identified mechanisms that enable advanced melanoma to become resistant to a new class of drugs, known as immunotherapies, which work by enlisting the body's own immune system to fight the disease. "This will help us to better design the next generation of treatment," said Dr Antoni Ribas, director of the tumor...

  • July 13- Novartis AG's cheaper version of Amgen Inc's arthritis drug Enbrel is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. Novartis tested the drug, GP2015, in patients with plaque psoriasis but if approved by the FDA, it would be approved for all...

  • NEW YORK— Juno Therapeutics and its CEO, Hans E. Bishop, are being named in a lawsuit over whether the biotechnology company misled investors about the death of a patient in a key study involving its drug intended to treat leukemia. The suit was filed this week in United States District Court for the Western District of Washington in Seattle. The lawsuit arrives...

  • Juno Therapeutics CEO on FDA greenlight

    CNBC's Meg Tirrell speaks with Juno Therapeutics CEO Hans Bishop about the FDA's decision to take his company's immunotherapy trial off clinical hold.

  • July 12- Juno Therapeutics Inc said U.S. health regulators have removed a clinical hold on its cancer drug trial that was put in place last week following the death of three patients, sending its shares up about 28 percent in extended trading. Last week, the U.S. Food and Drug Administration halted the mid-stage trial of the company's genetically engineered...

  • July 12- Amgen Inc's cheaper version of AbbVie's top-selling arthritis drug Humira is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committee but typically does. The panel's conclusions were consistent with those...

  • July 12- Amgen Inc's cheaper version of AbbVie's top-selling arthritis drug Humira is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26-0 that the drug, ABP 501, was similar in potency and safety to the original and that there was no meaningful clinical...

  • One hot biotech

    Jeff Jonas, Sage Therapeutics CEO, discusses a new way to treat postpartum depression. With CNBC's Meg Tirrell.

  • July 12- Sage Therapeutics Inc said its lead drug alleviated symptoms of severe postpartum depression, meeting the main goal of a small mid-stage study and sending the company's shares soaring in morning trading. About one in seven women experience postpartum depression, a severe form of "baby blues" that eventually interferes with her ability to take care of...

  • July 12- Sage Therapeutics Inc said its drug alleviated symptoms of severe postpartum depression, meeting the main goal of a small mid-stage study and sending the company's shares soaring. About one in seven women experience postpartum depression, a severe form of "baby blues" that eventually interferes with her ability to take care of the baby and handle daily...

  • July 12- Sage Therapeutics Inc said its drug alleviated symptoms of severe postpartum depression, meeting the main goal of a small mid-stage study and sending the company's shares soaring. Up to one in seven women experience PPD, according to the American Psychological Association. "This is potentially one of the most important clinical findings in the...

  • July 12- Sage Therapeutics Inc said its experimental drug to treat severe postpartum depression met the main goal of alleviating symptoms more than a placebo in a mid-stage study. Postpartum depression, or the "baby blues," impacts some women after childbirth, and can have several manifestations including significant functional impairment, depressed mood...

  • July 11- The U.S. Food and Drug Administration on Monday approved Shire Plc's lifitegrast eye drops for treating signs and symptoms of dry eye disease, allowing the company to bring to market its most important pipeline medicine. Lifitegrast, which will be marketed as Xiidra in the United States, is expected to launch in the third quarter. It treats an eye disease...

  • July 8- Amgen Inc's version of AbbVie Inc's Humira arthritis drug, the world's top-selling medicine, appears similar in potency and safety to the original product, U.S. Food and Drug Administration staff members said on Friday. In two large Amgen studies, the Thousand Oaks, California- based company said it showed similar effectiveness to Humira.

  • July 8- Amgen Inc's version of AbbVie Inc's Humira arthritis drug, the world's top-selling medicine, appears similar in potency and safety to the original product, U.S. Food and Drug Administration staff members said on Friday. In two large Amgen-sponsored studies, the Thousand Oaks, California- based company said it showed similar effectiveness to Humira.

  • July 8- Amgen Inc's biosimilar form of AbbVie Inc's Humira arthritis drug, the world's top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration. The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers who will...

  • Elizabeth Holmes

    U.S. regulators have banned Elizabeth Holmes, the chief executive of Theranos, from owning or operating a laboratory for at least two years.

  • The U.S. Food and Drug Administration halted the trial after a patient died in May and two more died last week, Juno Chief Executive Officer Hans Bishop told reporters on a conference call. Seattle- based Juno said the deaths occurred after the chemotherapy agent fludarabine was added to the trial program. The company said it has proposed to the U.S. Food and Drug...