Content about Gilead

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.

February 23, 2012

A Northern Ireland pharmaceutical company has acquired a chemotherapy agent from Gilead.

SOUDERTON, Pa. — A Northern Ireland pharmaceutical company has acquired a chemotherapy agent from Gilead.

Galen said it has acquired DaunoXome (daunorubicin citrate liposome injection), an anthracycline chemotherapy agent that was first approved in the United States in 1996, and is indicated as a first-line cytotoxic therapy for advanced HIV-associated Kaposi’s sarcoma. Galen said its wholly owned subsidiary, Galen US, will market the drug in the United States. DaunoXome will be made available through wholesalers in the United States.

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.

November 21, 2011

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 6, 2011

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.

July 19, 2011

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 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.

June 28, 2011

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

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.

March 14, 2011

Drug maker Gilead acknowledged the receipt of an unsolicited mini-tender offer by TRC Capital.

FOSTER CITY, Calif. — Drug maker Gilead acknowledged the receipt of an unsolicited mini-tender offer by TRC Capital.

Gilead said that TRC seeks to purchase up to 3 million shares of the company at a price of $37.25 per share, or about $111.75 million. The drug maker said it is recommending shareholders reject the bid, stating that the offer is priced below the current market price for Gilead shares and is subject to numerous conditions. As of March 2, TRC's offer price represented approximately a 4.56% discount to the $39.03 closing price of Gilead common stock.

March 4, 2011

Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker's hypertension treatment.

FOSTER CITY, Calif. — Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker's hypertension treatment.

Gilead said the FDA approved a change to the prescribing information for Letairis (ambrisentan 5-mg and 10-mg tablets), the company’s once-daily treatment of pulmonary arterial hypertension.

February 23, 2011

Drug maker Gilead Sciences plans to buy out a privately owned Seattle company that makes treatments for cancer and inflammatory diseases, Gilead said Tuesday.

FOSTER CITY, Calif. — Drug maker Gilead Sciences plans to buy out a privately owned Seattle company that makes treatments for cancer and inflammatory diseases, Gilead said Tuesday.

The Foster City, Calif.-based company will buy Calistoga Pharmaceuticals for $375 million, plus additional milestone payments of up to $225 million.

September 12, 2010

An investigational treatment for HIV by Gilead Sciences that combines four drugs in one tablet...

FOSTER CITY, Calif. An investigational treatment for HIV by Gilead Sciences that combines four drugs in one tablet works as well as a drug already on the market, Gilead said Monday.

 

August 30, 2010

A generic drug maker has filed an abbreviated new drug application for its version of...

FOSTER CITY, Calif. A generic drug maker has filed an abbreviated new drug application for its version of a Gilead Sciences drug.

FOSTER CITY, Calif. A generic drug maker has filed an abbreviated new drug application for its version of a Gilead Sciences drug.

June 27, 2010

Gilead Sciences plans to acquire a development-stage pharmaceutical company for up to $120 million, Gilead...