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Gilead

Boehringer signs away HIV rights to focus on hep C

Boehringer

Boehringer Ingelheim has signed a deal giving Gilead Sciences exclusive worldwide rights to a major part of its HIV portfolio.

The deal will allow Boehringer to concentrate on other areas of its virology portfolio, in particular hepatitis C where its lead compound - BI 201335 – moved into Phase III trials earlier this year.

Triple regimen HIV pill gains approval

A new three-in-one pill Complera has been approved in the US as a first line treatment for HIV.

Complera combines three antiretroviral drugs in a once-daily pill – Gilead’s emtricitabine and tenofovir disoproxil fumarate, and J&J’s similar rilpivirine.

Under its deal with J&J, Gilead will keep around 30% from what it makes from the Edurant component in Complera.

Gilead’s emtricitabine and tenofovir disoproxil fumarate are already on the market as a 2-in-1 called Truvada and J&J’s rilpivirine is known by the brand name Edurant.

Gilead buys manufacturing plant from Genentech

Roche unit Genentech has agreed to sell a clinical manufacturing plant in California to Gilead Sciences.

The 70,000 sq. ft. clinical plant in Oceanside makes supplies of experimental drugs for clinical testing, and is designed and equipped to produce biologic compounds for toxicological, phase I and phase II clinical studies. Genentech says these functions will move to its headquarters in San Francisco.

Gilead manufacturing under investigation by US authorities

Gilead Sciences is being investigated by the US authorities over the manufacturing and distribution of some of its products, and is 'cooperating' with the inquiry.

On Friday the drugmaker confirmed it had received a subpoena from the US Department of Justice for documents related to the "manufacture, and related quality and distribution practices", for a number of its top medicines.

The probe is looking at Gilead's actions in the context of both civil and criminal law, said the firm in a press release.

Gilead set to acquire Arresto for $225 million

Gilead Sciences is set to acquire fellow California, US-based biotech Arresto for $225 million to bolster its early stage pipeline.

Arresto develops medicines that target enzymes involved in the synthesis of the extracellular matrix, and these appear to play a role in the cause of a variety of fibrotic diseases and cancer.

Gilead's pill shows promise in HIV prevention

Gilead’s HIV drug Truvada can help prevent men from contracting the disease through sexual intercourse, a new study shows.

The clinical trial is the first ever to show a pill could actually prevent the transmission of the disease, opening up the possibility of prophylactic use of HIV drugs.

The promising trial was sponsored by the Bill and Melinda Gates Foundation and published in The New England Journal of Medicine.

It showed an average 44% reduction in HIV risk for participants receiving treatment compared to placebo.

FDA warns Gilead over contamination risks at California facility

Gilead Sciences has been sent a warning letter from the FDA after failing to rectify problems at a facility used to manufacture its antifungal product AmBisome and HIV treatment Viread.

The plant in San Dimas, California, was inspected by the US regulator i

Gilead is latest drugmaker in FDA's sights

A manufacturing and distribution facility operated by US biotech Gilead Sciences is at risk of receiving a warning letter from the FDA unless management can bring it back up to scratch.

The plant in San Dimas, California, underwent a routine inspection by the US regulator in January and February 2010 which resulted in a number of deficiencies being recorded via a Form 483 (a notice of inspectional observations).

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