Content about Gilead Sciences

April 30, 2013

The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

FOSTER CITY, Calif. — The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

April 4, 2013

FDA grants tentative approval to Aurobindo HIV drug

The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection, the drug maker said.

HYDERABAD, India — The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection in developing countries, the drug maker said.

Aurobindo announced that it had received tentative approval for efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets in the 600-mg/200 mg/300-mg strength. The drug is a generic version of Gilead Sciences' Atripla.

February 19, 2013

Gilead voluntarily recalls one lot of injected AIDS-related infection drug

Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter, the company said.

FOSTER CITY, Calif. — Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter in some vials, the company said.

Gilead announced the voluntary recall of lot B120217A of Vistide (cidofovir), an injected drug used to treat cytomegalovirus retinitis in patients with AIDS, due to particulate matter.

January 15, 2013

Switching to multi-pill generic HIV treatment could diminish effectiveness, study finds

While replacing a single combination pill for HIV with generics would save the healthcare system money, it could also diminish the effectiveness of treatment, a new study suggests.

NEW YORK — While replacing a single combination pill for HIV with generics would save the healthcare system money, it could also diminish the effectiveness of treatment, a new study suggests.

The study, led by investigators at the Massachusetts General Hospital and Weill Cornell Medical College, and published in the Jan. 15 issue of Annals of Internal Medicine, found $1 billion in potential savings, but the more complicated treatment regimen might result in more patients missing doses and a loss of drug effectiveness.

December 28, 2012

Teva delays sales of Gilead generics pending court ruling

Teva Pharmaceuticals USA will delay the sales of generic versions of two Gilead Sciences HIV drugs until June 2013, the company stated.

NEW YORK — Teva Pharmaceuticals USA will delay the sales of generic versions of two Gilead Sciences HIV drugs until June 2013, the company stated. The decision comes pending a long-running patent suit in the U.S. District Court for the Southern District of New York.

Teva may launch generics for Truvada (i.e., emtricitabine/tenofovir disoproxil fumarate) and Viread (i.e., tenofovir disoproxil fumarate) on June 1 if there is no ruling holding that the patents-in-suit are invalid or unenforceable, according to an agreement filed between the drug makers Nov. 27.

August 3, 2012

Mylan, Gilead sign HIV/AIDS drug deal

Mylan and Gilead Sciences have made an agreement under which Mylan will have rights to produce and market generic versions of Gilead drugs for HIV and AIDS in developing countries.

PITTSBURGH — Mylan and Gilead Sciences have made an agreement under which Mylan will have rights to produce and market generic versions of Gilead drugs for HIV and AIDS in developing countries.

The agreement, involving Gilead and Mylan subsidiary Mylan Labs Ltd., centers around drugs containing emtricitabine, the active ingredient in such drugs as Emtriva, and such fixed-dose combinations as Truvada (emtricitabine and tenofovir disoproxil fumarate) and the experimental Quad.

July 16, 2012

Gilead's Truvada approved for PrEP

The Food and Drug Administration has approved a drug used to treat HIV for reducing the risk of HIV infection, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug used to treat HIV for reducing the risk of HIV infection, the agency said Monday.

June 29, 2012

Gilead seeks approval for HIV drug-boosting agent

Drug maker Gilead Sciences has submitted a regulatory approval application to the Food and Drug Administration for a drug designed to increase the blood levels of certain drugs for HIV.

FOSTER CITY, Calif. — Drug maker Gilead Sciences has submitted a regulatory approval application to the Food and Drug Administration for a drug designed to increase the blood levels of certain drugs for HIV.

May 14, 2012

FDA panel recommends approval for experimental Gilead HIV drug

A Food and Drug Administration expert panel has recommended approval of a drug made by Gilead Sciences for treating HIV, the drug maker said Friday.

FOSTER CITY, Calif. — Gilead Sciences scored a second favorable Food and Drug Administration expert panel vote as the FDA's Antiviral Drugs Advisory Committee recommended on Friday that the regulatory agency approve an experimental drug designed to treat HIV.

May 11, 2012

FDA advisory committee recommends PrEP approval for Truvada

An expert panel at the Food and Drug Administration has recommended that the agency approve a drug made by Gilead Sciences for lowering the risk of infection by the virus that causes AIDS.

FOSTER CITY, Calif. — An expert panel at the Food and Drug Administration has recommended that the agency approve a drug made by Gilead Sciences for lowering the risk of infection by the virus that causes AIDS.

May 9, 2012

Reports: FDA may be close to approving drug for HIV prevention

The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

NEW YORK — The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

The Associated Press reported that the FDA had said Truvada (emtricitabine and tenofovir disoproxil fumarate), made by Gilead Sciences, appeared to be safe and effective for preventing HIV infection when taken daily. An FDA advisory committee will review the drug and decide whether to recommend its approval for pre-exposure prophylaxis, or PrEP.

February 14, 2012

FDA grants priority review to Gilead's Truvada for HIV prevention

The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.

FOSTER CITY, Calif. — The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.

Gilead said the FDA gave the special designation to its application for Truvada (emtricitabine and tenofovir disoproxil fumarate) for pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV infection. The FDA originally approved Truvada for treating HIV infection in 2004, and it is currently the most prescribed antiretroviral drug in the United States.

January 19, 2012

Gilead receives FDA approval for lower-dose HIV drug in children

The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.

January 18, 2012

Gilead completes acquisition of Pharmasset

Drug maker Gilead Sciences has completed its $11.2 billion acquisition of Pharmasset, Gilead said.

FOSTER CITY, Calif. — Drug maker Gilead Sciences has completed its $11.2 billion acquisition of Pharmasset, Gilead said.

The $137-per-share merger, originally announced in November 2011, makes Pharmasset a wholly owned subsidiary of Gilead. Pharmasset, based in Princeton, N.J., focuses on developing orally administered drugs for viral infections, particularly hepatitis C.

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January 3, 2012

FDA accepts application for Gilead HIV drug

The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

Gilead said the FDA planned to review the application for the Quad by Aug. 27.

The Quad combines four Gilead drugs — Truvada (emtricitabine and tenofovir disoproxil fumarate), cobicistat and elvitegravir — into one pill. The last drug was licensed from Japan Tobacco.

November 21, 2011

Gilead Sciences acquires Pharmasset for $11 billion

Drug maker Gilead Sciences will acquire Pharmasset for $11 billion, or $137 per share, Gilead said Monday.

FOSTER CITY, Calif. — Drug maker Gilead Sciences will acquire Pharmasset for $11 billion, or $137 per share, Gilead said Monday.

Pharmasset, based in Princeton, N.J., is a drug maker that currently has three treatments for hepatitis C undergoing clinical trials, including PSI-7977, which is in late-stage development.

October 27, 2011

Bristol-Myers Squibb, Gilead Sciences to develop, commercialize HIV combo treatment

Drug makers Bristol-Myers Squibb and Gilead Sciences announced an agreement to develop and commercialize a fixed-dose combination treatment for patients with HIV.

FOSTER CITY, Calif. — Drug makers Bristol-Myers Squibb and Gilead Sciences announced an agreement to develop and commercialize a fixed-dose combination treatment for patients with HIV.

The two companies said the drug will combine Bristol's Reyataz (atazanavir sulfate) and Gilead's boosting agent cobicistat, which is designed to increase blood levels of certain HIV medicines to potentially allow for one-pill, once-daily dosing. Gilead is currently studying Reyataz and cobicistat in phase-2 and phase-3 trials.

October 6, 2011

Gilead, Boehringer Ingelheim ink license agreement

Gilead Sciences has signed an agreement with Boehringer Ingelheim to gain exclusive worldwide rights to research, develop and commercialize BI's novel anti-retroviral compounds.

FOSTER CITY, Calif., and INGELHEIM, Germany — Gilead Sciences has signed an agreement with Boehringer Ingelheim to gain exclusive worldwide rights to research, develop and commercialize BI's novel anti-retroviral compounds.

Under the terms of the agreement, Gilead will pay the German drug maker an upfront payment and possibly will receive additional payments based upon the achievement of certain development, regulatory and commercial milestones, as well as royalties on future net sales, the companies said.

August 11, 2011

FDA approves single-pill HIV drug

The Food and Drug Administration has approved a new single-pill treatment for HIV made by Gilead Sciences and Johnson & Johnson, Gilead said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved a new single-pill treatment for HIV made by Gilead Sciences and Johnson & Johnson, Gilead said.

Gilead announced the approval of Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate). The drug combines Gilead's Truvada with J&J's Edurant.

July 19, 2011

Matrix expands licensing agreement with Gilead for HIV/AIDS therapies

Mylan subsidiary Matrix Labs has expanded its licensing agreement with Gilead Sciences.

PITTSBURGH — Mylan subsidiary Matrix Labs has expanded its licensing agreement with Gilead Sciences.

Under the new terms, Mylan said that Matrix has the rights to produce and market generic versions of three Gilead HIV/AIDS therapies — elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the “quad,” a once-daily, single-tablet combination of four separate Gilead medicines — if and when the drugs receive regulatory approval.

July 19, 2011

Ranbaxy to produce, market antiretrovirals under licensing agreement with Gilead

Ranbaxy will produce and market three HIV/AIDS drugs that currently are in late-stage clinical development by Gilead under a new licensing agreement between the drug makers.

GURGAON, India — Ranbaxy will produce and market three HIV/AIDS drugs that currently are in late-stage clinical development by Gilead under a new licensing agreement between the drug makers.

July 13, 2011

Studies find HIV drug treatments may reduce infection risk among heterosexual couples

Taking drugs for treating HIV might reduce the risk of infection among heterosexual couples, according to two new studies conducted in Africa.

NEW YORK — Taking drugs for treating HIV might reduce the risk of infection among heterosexual couples, according to two new studies conducted in Africa.

One study, funded by the Bill & Melinda Gates Foundation and conducted among 4,758 couples in Kenya and Uganda, found that when taken daily, Gilead’s Viread (tenofovir) reduced the rates of infection by at least 62% compared with placebo. Truvada (tenofovir and emtricitabine), another drug made by Gilead, reduced infection risk by 73%.

June 30, 2011

Physicians urge FDA not to approve Truvada

A group of physicians is urging the Food and Drug Administration not to approve a drug made by Gilead Sciences for the prevention of HIV infection.

LOS ANGELES — A group of physicians is urging the Food and Drug Administration not to approve a drug made by Gilead Sciences for the prevention of HIV infection.

Fifty-five physicians signed a letter spearheaded by the AIDS Healthcare Foundation citing concerns about the use of Gilead’s Truvada (tenofovir disoproxil fumarate and emtricitabine) for “pre-exposure prophylaxis,” or PrEP. Concerns included the risk of a decrease in condom use and a lack of information showing proper use in “real world” situations.

June 28, 2011

Gilead, Tibotec to develop HIV drug

A subsidiary of Johnson & Johnson and Gilead Sciences will collaborate to develop a combination drug for HIV, the two companies said Tuesday.

CORK, Ireland — A subsidiary of Johnson & Johnson and Gilead Sciences will collaborate to develop a combination drug for HIV, the two companies said Tuesday.

Gilead and Tibotec Pharmaceuticals will work to create a once-daily, single-tablet combination of Tibotec’s Prezista (darunavir) and Gilead’s investigational drug cobicistat, a so-called boosting agent.

March 17, 2011

Gilead, Roche sue Natco Pharma over generic Tamiflu

Drug makers Gilead Sciences and Roche are suing Indian drug maker Natco Pharma concerning a generic version of an influenza treatment, according to published reports.

NEW YORK — Drug makers Gilead Sciences and Roche are suing Indian drug maker Natco Pharma concerning a generic version of an influenza treatment, according to published reports.

Bloomberg reported that Gilead and Roche were accusing Natco of patent infringement due to its efforts to gain approval from the Food and Drug Administration for a generic version of Tamiflu (oseltamivir phosphate). Natco became the first company to file for approval of a generic version in February.