Genentech

FDA approves first biosimilar for certain breast and stomach cancers

Friday, December 8, 2017

The FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.

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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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FDA grants Priority Review for Genentech’s Gazyva

Tuesday, August 29, 2017

Genentech, a member of the Roche Group, announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults. Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and characterized by cycles of remission and relapse.

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Crohn’s & Colitis Foundation launches IBD Clinical Trials Community

Monday, July 24, 2017

Clinical trial recruitment is a challenging step toward FDA approval of new treatments for patients across all disease states; this is especially true for inflammatory bowel diseases (IBD). The Crohn’s & Colitis Foundation launched a dedicated Clinical Trials Community for IBD. The Community is designed to educate patients, caregivers, and healthcare providers about the clinical trial process, its value, and how to address barriers that exist in enrollment.

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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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