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Biotech and Pharmaceuticals Medicine

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  • Abbvie gets U.S. FDA approval for Hep C drug Friday, 24 Jul 2015 | 11:42 AM ET

    July 24- The U.S. Food and Drug Administration approved Abbvie Inc's treatment that targets the most common genotype, or genetic makeup, of hepatitis C virus. The drug, Technivie, was approved for the treatment of hepatitis C virus genotype 4 infections, the regulator said on Friday. The drug is approved for use in combination with the compound, ribavirin, for the...

  • How effective is new malaria vaccine? Friday, 24 Jul 2015 | 11:40 AM ET
    How effective is new malaria vaccine?

    Suki Virji, analyst for Scrip Intelligence, discusses the malaria vaccine developed by GlaxoSmithKline, which has received a "green light" by the European Medicines Agency.

  • LONDON, July 24- AstraZeneca is dipping its toe in the biosimilars market, as a way to make future cancer drug cocktails more affordable, by linking with a Japanese group to develop a copy of Roche's blockbuster medicine Avastin. FKB-- itself a tie-up between Fujifilm and Kyowa Hakko Kirin-- commenced a Phase I clinical trial of its copy of Avastin, called FKB238, in...

  • *Sanofi/ Regeneron PCSK9 drug Praluent endorsed by EMA. *Praluent to compete with Amgen's rival product Repatha. LONDON, July 24- A new type of cholesterol drug from Sanofi and Regeneron Pharmaceuticals won a green light from European regulators on Friday, two months behind a rival product from Amgen.

  • July 24- Sales of Biogen Inc's roster of multiple sclerosis drugs failed to meet analysts' expectation, prompting the company to slash its full-year profit and sales forecast. Tecfidera's sales were $833 million in the second quarter ended June 30, well below Wall Street's estimate of about $933 million, according to Evercore ISI. Sales of Biogen's injectable...

  • LONDON, July 24- A new type of cholesterol drug from Sanofi and Regeneron Pharmaceuticals won a green light from European regulators on Friday, two months behind a rival product from Amgen. Amgen's Repatha was formally approved by the European Commission on Tuesday after a positive EMA opinion in May and Praluent is likely to be cleared by the Commission after a...

  • *EU regulators back GSK's Mosquirix for babies in Africa. LONDON, July 24- The world's first malaria vaccine got a green light on Friday from European drugs regulators who recommended it as safe and effective to use in babies in Africa at risk of the mosquito-borne disease. Mosquirix, also known as RTS, S and part-funded by the Bill& Melinda Gates Foundation, will now...

  • Blood testing goes digital: CEO Friday, 24 Jul 2015 | 4:30 AM ET
    Blood testing goes digital: CEO

    Yossi Pollak, chief executive officer at Sight Diagnostics, explains how computer algorithms make blood testing more efficient.

  • LONDON, July 24- The world's first malaria vaccine got a green light on Friday from European drugs regulators who recommended it should be licensed for use in babies in Africa at risk of the mosquito-borne disease. Recommendations for a drug licence made by the European Medicines Agency are normally endorsed by the European Commission within a couple of...

  • NEW YORK— Shares of Sunesis Pharmaceuticals plunged in aftermarket trading Thursday after the company said it will focus on trying to get its blood cancer drug Qinprezo on the market in Europe because regulators in the U.S. won't approve it based on available data. The Food and Drug Administration doesn't support a filing, Sunesis said. Sunesis shares fell...

  • Rise in autism may be due to semantics: Study Thursday, 23 Jul 2015 | 10:27 AM ET
    Autism

    A new study suggests the idea that more kids are being diagnosed with autism due to reclassification of the issue, NBC reports.

  • Agriculture Secretary Tom Vilsack told the House Agriculture Committee at a hearing on Wednesday. Developing a vaccine targeted to the H5N2 virus that has killed 48 million birds since early March in 15 states, including hardest-hit Iowa, Minnesota and Nebraska, is one aspect of planning for a potential recurrence of the bird flu, Vilsack said.

  • Waking the sleep disorder market Wednesday, 22 Jul 2015 | 4:40 AM ET
    Waking the sleep disorder market

    Gilad Glick, CEO of Itamar Medical, explains how his home-test product is trying to cure sleep disorder and heart problems.

  • DES MOINES, Iowa— One of the first Iowa turkey farms where bird flu was found is getting close to the time at which birds can be restocked, but most of the 77 farms affected are still weeks away from introduction of new flocks, Iowa Department of Agriculture officials said Tuesday. The bird flu outbreak began in Iowa in mid-April. One turkey farm in Calhoun County will...

  • Bristol-Myers says HIV drug gets FDA incentives Tuesday, 21 Jul 2015 | 1:13 PM ET

    The Food and Drug Administration designated the drug BMS-663068 as a breakthrough treatment, so Bristol-Myers Squibb Co. will get extra meetings with the FDA and earlier communication with scientists as it studies the drug. There are six classes of HIV drugs, according to the National Institutes of Health, and patients are typically treated with drugs from...

  • July 21- Novavax Inc said its experimental Ebola vaccine induced a substantial immune response to the deadly infection in an early-stage trial involving 230 healthy adults. Potential partners include the Biomedical Advanced Research and Development Authority, a division of U.S. Department of Health and Human Services, which Novavax is already working...

  • Europe approves Amgen's first-in-class cholesterol drug Tuesday, 21 Jul 2015 | 10:49 AM ET

    WASHINGTON— Amgen on Tuesday received European approval for its first-of-a-kind cholesterol drug that lowers levels of the artery-clogging substance more than older drugs that have been prescribed for decades. The U.S. Food and Drug Administration is scheduled to make a decision on a similar drug from Sanofi and Regeneron Pharmaceuticals this Friday.

  • BRIEF-NOVAVAX INC SAYS POSITIVE TOP-LINE DATA FROM PHASE 1. *Positive top-line data from phase 1 trial of ebola virus glycoprotein recombinant nanoparticle vaccine candidate adjuvanted with matrix-m. *Trial demonstrated that ebola GP vaccine was highly immunogenic, well-tolerated and resulted in significant antigen dose-sparing.

  • July 21- Amgen Inc said the European commission approved its keenly anticipated cholesterol fighting drug, Repatha. The approval covers patients with a genetic predisposition to high cholesterol, those on maximum doses of statins and those who cannot realize enough benefit from them, the biotechnology company said on Tuesday. The drug is part of a new class of...

  • Tekmira Pharmaceuticals Corp. said last month that an experimental Ebola treatment that it was developing would probably fail in a clinical trial. The Canadian company says it will focus on experimental treatments for the hepatitis B virus and will change its name to Arbutus Biopharma Corp.. Other companies in the field included NewLink Genetics Corp.,...