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Biotech and Pharmaceuticals Medicine

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  • UPDATE 1-Bellerophon's heart device fails study Monday, 27 Jul 2015 | 7:31 AM ET

    July 27- Bellerophon Therapeutics Inc said its implantable heart device failed to prevent heart failure in patients in a large study, casting doubts over an approval for the device in Europe. The device, Bioabsorbable Cardiac Matrix, was licensed to Bellerophon by BioLineRx Ltd in 2009.. BioLineRx's U.S.-listed shares fell 18 percent to $1.76 in premarket...

  • Bellerophon's heart device fails study Monday, 27 Jul 2015 | 6:36 AM ET

    July 27- Bellerophon Therapeutics Inc said its implantable heart device failed to prevent heart failure in patients in a large study, casting doubts over an approval for the device in Europe. The device, Bioabsorbable Cardiac Matrix, was tested in 303 patients who had already suffered a heart attack. The device was licensed to Bellerophon by BioLineRx Ltd in...

  • July 24- The U.S. Food and Drug Administration on Friday approved two treatments for less common forms of hepatitis C virus infections. The regulator cleared AbbVie Inc's Technivie, which targets HCV genotype 4 infections, and Bristol-Myers Squibb Co's Daklinza, used to treat HCV genotype 3 infections. Technivie, includes the same cocktail of drugs that...

  • WASHINGTON, July 24- The U.S. Food and Drug Administration approved a potent new cholesterol-lowering drug from Sanofi SA and Regeneron Pharmaceuticals Inc on Friday but limited its approved use to patients with a hereditary form of the condition and those with cardiovascular disease. The FDA ruling came just hours after European regulators recommended...

  • July 24- The U.S. Food and Drug Administration approved Novartis AG's oral pill to treat the most common form of advanced skin cancer. Roche Holding AG's Erivedge was the first pill to be approved in 2012 by the FDA for the condition. One in five Americans are likely to develop skin cancer in their lifetime, according to the American Academy of Dermatology.

  • July 24- The U.S. Food and Drug Administration approved AbbVie Inc's treatment that targets hepatitis C virus with the rarest genotype, or genetic makeup. The three drugs included in Technivie are also in Viekira Pak, AbbVie's treatment for genotype 1 hep C virus infection. Separately, AbbVie reported lower-than-expected revenue for the first time in six...

  • 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...

  • 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.

  • 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.

  • 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...

  • 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...