Tag Archives: Gilead

Gilead challenges GSK with strong HIV drug data

A GlaxoSmithKline logo is seen outside one of its buildings in LondonGilead Sciences has thrown down a challenge to GlaxoSmithKline with good clinical trial results for an experimental HIV drug that works in the same way as the British group's successful dolutegravir. Gilead's bictegravir, another so-called integrase inhibitor drug, delivered 97 percent virus suppression, making it just as effective as GSK's product, data presented at a medical meeting in Seattle late on Monday showed. Importantly, there were no cases of resistance emerging to the new medicine in the 98-patient Phase II study and no patients discontinued treatment due to kidney problems, which can be an issue with HIV treatments.



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GlaxoSmithKline and Gilead to face off at HIV meeting next week

File photo of a GlaxoSmithKline logo outside one of its buildings in west LondonBy Ben Hirschler LONDON (Reuters) – GlaxoSmithKline and Gilead Sciences will vie for business in treating HIV patients next week when both companies unveil clinical trial results at a medical meeting in Seattle. Most attention is focused on Gilead's next-generation drug bictegravir, a so-called integrase inhibitor similar to GSK's successful dolutegravir that may offer advantages in terms of greater potency and reduced side effects. As dolutegravir has been the mainstay of GSK's HIV business in recent years, investors are nervous about the threat posed by Gilead's competitor, even though next week's bictegravir data is only from mid-stage Phase II testing.



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Switching course, Gilead markets HIV drug for prevention

By Jilian Mincer NEW YORK (Reuters) – Gilead Sciences Inc has begun marketing its HIV treatment Truvada in a way thousands of consumers already use it – to prevent infection with the virus that causes AIDS. The company introduced Truvada to the U.S. market in 2004 for HIV treatment. In 2012, Gilead won approval to market it for prevention after two large, peer-reviewed studies showed it also was effective at preventing infections in healthy people.
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J&J vaccine plus Gilead immune booster shows promise as HIV fighter

By Julie Steenhuysen CHICAGO (Reuters) – An experimental HIV vaccine from Johnson & Johnson combined with an immune system booster from Gilead Sciences Inc showed promise at keeping the virus at bay in monkeys even after treatments had stopped, marking yet another step toward the development of a so-called functional cure for HIV. The study, published on Wednesday in the journal Nature, evaluated monkeys infected with simian immunodeficiency virus, the monkey version of HIV, and showed the treatments were much more effective when used together than separately. All nine monkeys that got both treatments showed significantly reduced viral loads.
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FDA approves Gilead Sciences’ HIV drug cocktail

(Reuters) – Gilead Sciences Inc said on Thursday the U.S. Food and Drug Administration approved its HIV drug cocktail, Genvoya, to treat infection in adults and patients 12 years of age and older. The label also states that Genvoya is not approved to treat patients with chronic hepatitis B virus infection. Genvoya – which is developed from Stribild, an older version of the four drug cocktail – also received positive opinions from European health regulators in September.
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Gilead combo HIV pill matches Truvada efficacy but safer in trial

(Reuters) – Gilead Sciences Inc said on Wednesday its experimental fixed-dose combination treatment for HIV proved as effective in a late-stage study as the company’s widely used Truvada combo pill but with significantly less loss of bone mineral density and kidney function. The company has already sought U.S. and European marketing approval for the new combo pill nicknamed F/TAF, which is meant to be a safer replacement for Truvada, a cornerstone of HIV treatment that has been associated with slight declines in bone mineral density and kidney function. “The results of this and other recent trials demonstrate the potential of F/TAF to become a next-generation backbone” of treatment for HIV, the biotechnology company said in a release.
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Gilead aims to license hepatitis C drug to 3-4 Indian firms

By Ben Hirschler LONDON (Reuters) – Gilead Sciences aims to license its new hepatitis C drug Sovaldi to three or four Indian generic manufacturers to allow sales of the medicine at lower prices in some 60 developing nations. Clifford Samuel, head of access operations and emerging markets at the U.S. drugmaker, told Reuters he expected to have deals in place shortly with the Indian firms, which would be able to produce the drug in high volumes and at low margins. Gilead is under pressure to address the high cost of its breakthrough pill, which is the first of a new wave of drugs that have been shown to raise cure rates and cut treatment duration without the side effects of current injections. He said Gilead was looking to strike deals with firms that had proven experience in producing generic versions of its HIV/AIDS drugs, such as the Indian division of Mylan.
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Gilead and GSK drugs for HCV and HIV win EU green light

The GlaxoSmithKline building is pictured in Hounslow, west LondonEuropean regulators have recommended approval of a new drug from Gilead Sciences to treat hepatitis C and an HIV medicine from GlaxoSmithKline, both of which are expected to be major sellers. The European Medicine Agency (EMA) said on Friday its committee of experts also gave the green light to a tuberculosis drug from Japan's Otsuka, following a review of an earlier rejection. Recommendations for marketing approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months. Analysts expect U.S.-based Gilead's sales to surge higher next year on the back of its treatment known as Sovaldi, or sofosbuvir, for people infected with the liver-destroying hepatitis C virus (HCV).



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EU regulators back Novartis inhaler, Gilead HIV drug

LONDON (Reuters) – European regulators on Friday recommended approval of a new once-daily inhaler for lung disease from Novartis and an HIV medicine from Gilead Sciences. Recommendations for marketing approval by the agency’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months. (Reporting by Ben Hirschler; editing by Kate Kelland)
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Experimental Gilead drug effective in early-stage leukemia trial

By Deena Beasley (Reuters) – An experimental drug from Gilead Sciences Inc shrank tumors in half of leukemia patients whose cancer had returned, according to an early-stage trial that represents a new foray into oncology by the world’s biggest seller of HIV medications. The pill, idelalisib, is part of a new class of medications designed to selectively block a type of protein known to promote tumor growth in patients with chronic lymphocytic leukemia (CLL) and other types of blood cancer. …
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