Content about Gilead Sciences

January 31, 2014

Mylan announced that its India-based subsidiary, Mylan Pharmaceuticals Private Limited, has been named Gilead Sciences' branded medicines business partner for India.

PITTSBURGH and MUMBAI, India — Mylan announced that its India-based subsidiary, Mylan Pharmaceuticals Private Limited, has been named Gilead Sciences' branded medicines business partner for India.

Under this exclusive agreement, Mylan will market and distribute in India the following drugs from Gilead:

December 27, 2013

The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

Gilead said the FDA approved its single-pill regimen, Complera (emtricitabine; rilpivirine; tenofovir disoproxil fumarate) for use in adult patients who have suppressed their infections on stable antiretroviral regimens and are replacing their current regimens. The FDA originally approved the drug in 2011.

December 13, 2013

Pharmacy benefit manager Express Scripts hopes to drive down the cost of new drugs to treat hepatitis C by pitting their manufacturers against each other, according to published reports.

NEW YORK — Pharmacy benefit manager Express Scripts hopes to drive down the cost of new drugs to treat hepatitis C by pitting their manufacturers against each other, according to published reports.

Bloomberg News reported that ESI would pit companies like Gilead Sciences against others such as AbbVie when the new treatments become available in 2014 or 2015. The Food and Drug Administration announced last week the approval of Gilead's new drug, Sovaldi (sofosbuvir), which is designed to cut by three quarters the time needed for treatment.

December 6, 2013

The Food and Drug Administration has approved a new drug for hepatitis C made by Gilead Sciences, the drug maker said Friday.

FOSTER CITY, Calif. — The Food and Drug Administration has approved a new drug for hepatitis C made by Gilead Sciences, the drug maker said Friday.

December 4, 2013

The availability of new generic drugs for treating HIV will erode sales of HIV antiretroviral drugs into the next decade in developed countries, according to a new report.

BURLINGTON, Mass. — The availability of new generic drugs for treating HIV will erode sales of HIV antiretroviral drugs into the next decade in developed countries, according to a new report.

Healthcare market research firm Decision Resources released the report Wednesday, showing that sales of antiretroviral drugs in the United States, France, Germany, the United Kingdom, Spain, Italy and Japan would be $13.1 billion in 2022, down from 2012's $13.4 billion.

November 15, 2013

The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.

NEW YORK — The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.

November 12, 2013

Rite Aid has elected the president and CEO of Catholic Health Initiatives to its board of directors, the retail pharmacy chain said Tuesday.

CAMP HILL, Pa. — Rite Aid has elected the president and CEO of Catholic Health Initiatives to its board of directors, the retail pharmacy chain said Tuesday.

Rite Aid announced the appointment of Kevin Lofton, who has worked with the Englewood, Colo.-based operator of hospitals and long-term care centers since 1998 and was appointed as its president and CEO in 2003.

October 24, 2013

An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

NEW YORK — An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

August 6, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

Lupin said the FDA approved its ranolazine extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is used to treat chronic angina.

Ranolazine extended-release tablets are a generic version of Gilead Sciences' Ranexa, which had sales of about $443.4 million during the 12-month period that ended in March, according to IMS Health.

 

May 23, 2013

In anticipation of new treatments for hepatitis C, a growing number of physicians have begun intentionally delaying treatment for patients, according to a new study.

EXTON, Pa. — In anticipation of new treatments for hepatitis C, a growing number of physicians have begun intentionally delaying treatment for patients, according to a new study.

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

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

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

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 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 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

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

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

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

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

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

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

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

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

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.