Gilead

X-Chem, Gilead collaborate

Friday, December 1, 2017

X-Chem, a privately held biotechnology company applying its innovative drug discovery platform to the generation of novel small molecule therapeutics, announced a drug discovery partnership with Gilead Sciences. Under the terms of the agreement, X-Chem will screen its proprietary DEXTM libraries, which contain >120 billion individually DNA-encoded small molecules, toward the discovery of novel, high-value therapeutic leads against targets in antiviral and additional therapeutic areas. Gilead has the option to license drug leads discovered under the collaboration, and will be responsible for further development and commercialization of the resulting programs.

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Partnership aims to accelerate development of new immunotherapy strategies

Monday, October 23, 2017

The Partnership for Accelerating Cancer Therapies (PACT) has launched thanks to a partnership between the NIH and 11 biopharmaceutical companies. The goal of the new partnership is to accelerate the development of new cancer immunotherapy strategies for more patients in half the time. The initiative specifically aims to explore the question: Why doesn’t immunotherapy work for all cancers, in all patients, and what can be done about it?

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NIH partners with 11 biopharmaceutical companies on cancer immunotherapy strategies

Friday, October 13, 2017

The NIH and 11 biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers—standardized biological markers of disease and treatment response—to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the Food and Drug Administration serving in an advisory role. 

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Gilead Sciences to acquire Kite Pharma for $11.9B

Monday, August 28, 2017

Gilead Sciences and Kite Pharma announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Kite for $180.00 per share in cash. The transaction, which values Kite at approximately $11.9 billion, was unanimously approved by both the Gilead and Kite Boards of Directors and is anticipated to close in the fourth quarter of 2017. The transaction will provide opportunities for diversification of revenues, and is expected to be neutral to earnings by year three and accretive thereafter.

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Gilead announces FDA priority review designation for fixed-dose treatment of HIV

Friday, August 11, 2017

Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for an investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI) and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection. Gilead filed the NDA for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.

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Fastest drug developers and their practices

Tuesday, August 1, 2017

Drug development is a long and costly process, and companies struggle with efforts to compress cycle times and reduce costs. A new CenterWatch analysis of new molecular entities (NMEs) approved by the FDA from 2014 through 2016 shows no signs of dramatic, industry-wide improvement. Sponsors interviewed by CenterWatch cited multiple factors that influence the speed of their development programs. In particular, the selection of investigative sites and vendors (including CROs), and the relationships forged with them, were an important focus of companies seeking to improve the speed and efficiency of clinical trials.

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Adimab announces platform transfer with Lilly

Friday, July 21, 2017

Adimab, a global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, has entered into an agreement with Eli Lilly to transfer the Adimab Platform to Lilly for the discovery and optimization of antibody-based drugs in all therapeutic areas. This technology transfer expands an ongoing collaboration between the two companies that was initiated in 2010, which has yielded several undisclosed therapeutic candidates for Lilly.

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Gilead releases Genvoya HIV-1 data

Thursday, February 16, 2017

Gilead Sciences announced 144-week data from two phase III studies (Studies 104 and 111) evaluating the safety and efficacy of Genvoya (elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg) for the treatment of HIV-1 infection in treatment-naïve adults. Through week 144, Genvoya demonstrated significantly higher rates of virologic suppression compared to Gilead’s Stribild (elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir disoproxil fumarate 300mg), based on the%age of patients with HIV-1 RNA levels less than 50 copies/mL. Patients receiving Genvoya also demonstrated favorable renal and bone laboratory parameters compared to those treated with Stribild.

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