Exelixis adds top personnel

Monday, September 28, 2015

Exelixis has announced three high-level appointments as the company prepares for the potential commercialization of its lead compound, cabozantinib, for the treatment of advanced renal cell carcinoma (RCC) following positive results from the METEOR pivotal phase III trial. William Berg, M.D., has joined the company as senior vice president of medical affairs, Jonathan Berndt as vice president of sales, and Gregg Bernier as vice president of marketing.

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Genentech initiates phase III trial of Rituxan

Thursday, August 27, 2015

Genentech has initiated a phase III clinical trial investigating the use of Rituxan (rituximab) in patients with pemphigus vulgaris (PV), a rare, chronic and potentially fatal, blistering skin disease. The aim of the study, called PEMPHIX, is to determine the efficacy and safety of Rituxan for the treatment of PV. The current standard-of-care includes high doses of corticosteroids taken for several weeks and corticosteroids in combination with the off-label use of corticosteroid-sparing immunosuppressive drugs for many months, which can cause significant, long-term side effects.

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FDA grants Breakthrough designation for Actemra in Systemic Sclerosis

Thursday, June 11, 2015

Genentech, a member of the Roche Group, has announced that the FDA has granted Breakthrough Therapy designation status to Actemra (tocilizumab) for systemic sclerosis, also known as scleroderma. This designation is intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases and to help ensure patients have access to them as soon as possible. Genentech also has initiated a phase III study in systemic sclerosis (NCT02453256), a disease for which there are inadequate treatment options.

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Denali Therapeutics launches to study neurodegenerative disease treatments

Friday, May 15, 2015

Denali Therapeutics, a new California-based biotechnology company focused on developing effective therapies for neurodegenerative diseases, has launched with an initial investment commitment of $217 million. Denali is based on the collaboration of world-class scientists, industry experts and investors. Recent scientific insights into the genetic causes and biological processes underlying neurodegenerative disease, together with new translational medicine tools, offer an unprecedented opportunity to discover and develop effective medicines for Alzheimer’s disease, Parkinson’s disease, ALS and other neurodegenerative diseases.

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AbbVie’s Venetoclax receives FDA Breakthrough Therapy designation for CLL

Thursday, May 7, 2015

AbbVie has announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

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