Onyx Pharmaceuticals

Bayer's Stivarga receives FDA approval for GIST

Tuesday, February 26, 2013 12:27 PM

The FDA has approved Bayer's Stivarga (regorafenib) tablets to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

More... »

FDA grants Bayer’s Stivarga NDA priority review

Thursday, November 1, 2012 11:49 AM

Bayer HealthCare and Onyx Pharmaceuticals, a biopharmaceutical company based in South San Francisco, announced today that the FDA has granted priority review to the New Drug Application (NDA) for Stivarga (regorafenib) tablets.

More... »

FDA approves new treatment for advanced colorectal cancer

Friday, September 28, 2012 12:19 PM

The FDA has approved Bayer’s and Onyx Pharmaceuticals’ Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body.

More... »

Bayer submits NDA for regorafenib for gastrointestinal stromal tumors

Friday, August 31, 2012 12:02 PM

Bayer HealthCare and Onyx Pharmaceuticals, a global biopharmaceutical company based in San Francisco, have submitted a New Drug Application (NDA) to the FDA for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment.

More... »

Onyx initiates phase III comparison trial in relapsed multiple myeloma

Friday, July 6, 2012 02:10 PM

Onyx Pharmaceuticals, a San Francisco-based global biopharmaceutical company, has begun enrollment in the ENDEAVOR trial, a phase III trial evaluating Kyprolis (proposed brand name for carfilzomib) in combination with dexamethasone, versus bortezomib (Velcade) with dexamethasone in patients with relapsed multiple myeloma.

More... »

Onyx completes enrollment for phase III trial

Monday, February 27, 2012 10:04 AM

San Francisco, Calif.-based Onyx Pharmaceuticals has reached the target enrollment in the ASPIRE trial, a phase III international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid) and low-dose dexamethasone in patients with relapsed multiple myeloma. 

More... »

FDA accepts NDA for myeloma drug

Tuesday, November 29, 2011 11:34 AM

The FDA has accepted Onyx Pharmaceuticals' New Drug Application (NDA)
submission for carfilzomib, a next generation proteasome inhibitor, for the potential treatment of patients with relapsed and refractory multiple myeloma.

More... »

Parker joins Human Genome Sciences as VP

Monday, August 8, 2011 12:08 PM

Human Genome Sciences has named Craig C. Parker its senior vice president, strategy and corporate development. He will report directly to H. Thomas Watkins, president and chief executive officer, and will serve as a member of the management committee.

More... »

Onyx Pharmaceuticals has pivotal carfilzomib phase IIb data

Friday, May 20, 2011 11:13 AM

Onyx Pharmaceuticals has updated results from the phase IIb 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

More... »

S*BIO reforms collaboration with Onyx

Wednesday, May 4, 2011 12:48 PM

Sinapore-based S*BIO will restructure its collaboration and option agreement with California-based Onyx Pharmaceuticals, which the companies entered into in January 2009. As a result of the restructuring, S*BIO has regained North American and European rights to its novel JAK2 inhibitors, SB1518 and SB1578, from Onyx.  Following a successful and productive partnership with Onyx, S*BIO will now be in a position to drive the development of its lead JAK2 program independently.

More... »