Navigation Links
Onyx Pharmaceuticals Receives Fast Track Designation for Carfilzomib; Company Initiates Rolling NDA Submission for Accelerated Approval
Date:1/31/2011

eloma. We are committed to making carfilzomib available to these very ill patients as quickly as possible."

Carfilzomib was granted orphan drug designation by the FDA for the treatment of multiple myeloma in 2008.  Orphan drug designation is granted to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Under the designation, the sponsor may be eligible for grant funding towards clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States following drug approval by the FDA.

About the Carfilzomib Development Program

Carfilzomib is a selective, next generation proteasome inhibitor that has shown encouraging results in a broad clinical trial program in multiple myeloma.  

The carfilzomib development program includes a large, randomized international Phase 3 clinical trial, known as the ASPIRE trial, studying the combination of lenalidomide and low dose dexamethasone with or without carfilzomib in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial. A second Phase 3 clinical trial, called the FOCUS trial, is evaluating carfilzomib in patients with relapsed and refractory myeloma in Europe. Carfilzomib is also being evaluated in a broad investigator sponsored trial program including 1st line multiple myeloma, combination studies, lymphoma and other malignancies.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed ann
'/>"/>

SOURCE Onyx Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Keryx Biopharmaceuticals, Inc. to Hold Conference Call on Second Quarter 2008 Financial Results on Monday, August 11, at 8:30 A.M. EDT
2. ISTA Pharmaceuticals Reports Second Quarter 2008 Financial Results
3. SGX Pharmaceuticals Announces Financial Results for the Three and Six Months Ended June 30, 2008
4. ADVENTRX Pharmaceuticals to Report Second Quarter 2008 Results
5. Merrimack Pharmaceuticals Initiates Enrollment in a Phase 1 Study of MM-121, an ErbB3 Antagonist
6. VIA Pharmaceuticals to Present at Fourth Annual Noble Financial Equity Conference
7. Anthera Pharmaceuticals Completes $19 Million Financing; Appoints Christopher S. Henney as Chairman
8. Access Pharmaceuticals to Present at the Noble Financial Equity Conference
9. Indevus Pharmaceuticals Announces Issuance of U.S. Patent for SANCTURA XR(TM)
10. XTL Biopharmaceuticals Receives Notice of Non-Compliance with Nasdaq Marketplace Rule Due to Changes in Board Composition
11. Lotus Pharmaceuticals Announces Second Quarter 2008 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... 14, 2014  3D Communications, a leading provider of strategic communications services ... media events in the United States and ... Virginia Cox , JD, is returning to the firm,s ... re-joins 3D after more than two years of service as Associate ...
(Date:1/14/2014)... BETHESDA, Md. , Jan. 14, 2014  Organovo announced ... from the National Institutes of Health (NIH) to help ... effective treatments to patients on a faster timeline. Organovo ... Sciences (NCATS) and the National Eye Institute (NEI) to ...
(Date:1/14/2014)... Global Record Systems, LLC, (GRS), a ... for patients, physicians, the biopharmaceutical industry, regulators, payers, ... signing of a three-year Research Collaboration Agreement (RCA) ... This initiative is designed to generate disruptive ...
(Date:1/14/2014)... 2014 During the 1600’s through the 1800’s ... Doctor’s Plague.” In this time period, doctors did not know ... times, to the death of vulnerable patients. In the same ... they may be unwittingly transmitting herpes viruses to their patients. ...
Breaking Biology Technology:Former FDA Associate Commissioner Returns To 3D Communications 2Organovo Announces Collaboration with National Institutes of Health 2Organovo Announces Collaboration with National Institutes of Health 3Global Record Systems Announces Research Collaboration Agreement with FDA to Create a Novel “Big Data” Paradigm for Collection of Patient Safety and Outcomes Information 2Study: Fatigued Medical Interns Infect Their Patients with Herpes Viruses; The CBCD Sees a Parallel with “The Doctor’s Plague” 2Study: Fatigued Medical Interns Infect Their Patients with Herpes Viruses; The CBCD Sees a Parallel with “The Doctor’s Plague” 3
... announced today that Mr. Paulo F. Costa has been elected ... Costa is the former President and Chief Executive Officer of ... experience in operations and commercialization in the pharmaceutical industry, Mr. ... , "We are privileged to have Mr. Costa join MacroGenics, ...
... Additions to the Human Protein Atlas, available exclusively through Sigma-Aldrich, ... Antibodies , , ST. LOUIS, June 23 Sigma-Aldrich ... over 2,300 antibody additions to its Prestige Antibodies(R) powered by ... the total number of highly validated antibodies to over 6,100. ...
... VIENNA, Austria, June 23 MIG Fonds and ... & Private Equity Award,competition, hosted by the industry magazine Boerse-Express ... venture fund and the Austrian biotechnology company as well as ... Last Tuesday MIG Fonds and AFFiRiS ...
Cached Biology Technology:Paulo F. Costa Joins MacroGenics Board of Directors 2Paulo F. Costa Joins MacroGenics Board of Directors 3Sigma-Aldrich and Atlas Antibodies Announce 2,300 New, Highly Validated Prestige Antibodies(RM) 2Sigma-Aldrich and Atlas Antibodies Announce 2,300 New, Highly Validated Prestige Antibodies(RM) 3Sigma-Aldrich and Atlas Antibodies Announce 2,300 New, Highly Validated Prestige Antibodies(RM) 4AFFiRiS AG: 1st Place in Venture Capital & Private Equity Awards for MIG Fonds and AFFiRiS 2AFFiRiS AG: 1st Place in Venture Capital & Private Equity Awards for MIG Fonds and AFFiRiS 3
(Date:4/24/2014)... pleased to announce that it has assumed ownership of ... University of Wisconsin. , The Journal of ... journal that publishes papers on all aspects of the ... molecular to the ecological -- as well as their ... individuals and institutions, and it provides a reasonably priced ...
(Date:4/24/2014)... improved with new insights into the make-up of tropical ... Amazon Basin have revealed unprecedented detail of the size, ... comparing satellite maps with hundreds of field plots. ... accurately the amount of carbon each tree can store. ... in which trees are given a cash value according ...
(Date:4/23/2014)... Africa,s Congo rainforest, the second-largest tropical rainforest in the ... the past decade. , The study, led by Liming ... York, shows between 2000 and 2012 the decline affected ... research, published Wednesday in Nature , is one ... effects of long-term drought on the Congo rainforest using ...
Breaking Biology News(10 mins):ESA to publish the Journal of Insect Science 2Amazon rainforest survey could improve carbon offset schemes 2NASA satellites show drought may take toll on Congo rainforest 2NASA satellites show drought may take toll on Congo rainforest 3
... a lot like a banana, strawberry and apple smoothie: Blended ... especially if you have never tasted the fruits before. ... has an incredible variety of known compounds. And looking closely ... time -- at a scale of 50 nanometers (1 nanometer ...
... latest American Chemical Society (ACS) News Service Weekly PressPac with ... News.,Please credit the individual journal or the American Chemical Society ... FOR IMMEDIATE USE EXCEPT ARTICLE #5, which is embargoed for ... #1 FOR IMMEDIATE RELEASE Study calls for action ...
... Spanish . , Fast identification of animal ... a guarantee of quality for consumers and producers. Consumption of ... of good taste and maximum gastronomic quality. In the last ... species, already exceeding the Spanish borders: Iberian ham, dried meat, ...
Cached Biology News:First nanoscale image of soil reveals an 'incredible' variety, rich with patterns 2American Chemical Society's Weekly PressPac -- April 23, 2008 2American Chemical Society's Weekly PressPac -- April 23, 2008 3American Chemical Society's Weekly PressPac -- April 23, 2008 4American Chemical Society's Weekly PressPac -- April 23, 2008 5American Chemical Society's Weekly PressPac -- April 23, 2008 6American Chemical Society's Weekly PressPac -- April 23, 2008 7American Chemical Society's Weekly PressPac -- April 23, 2008 8New computer applications allow to classify Iberian pig meat automatically 2
... Progenitors, Rabbit, and media. Cryo-preserved cells in ... at passage 25 (approx), supplied with kit ... is supplied as a long-term culture, and ... months of continuous growth from the date ...
... System provides a simple, rapid and ... glutathione-S-transferase (GST) fusion proteins. Immobilized glutathione ... to isolate GST-tagged protein directly from ... either a manual (requires use of ...
... harvesting of cells • Blade design minimizes ... the growth surface • Designed for use ... wrapped • Sterilized by gamma radiation and ... a new product number, created to easily ...
... Progesterone Receptor (PR) Competitor Assay Kits ... novel progesterone receptor binding compounds using ... utilizes a fusion of glutathione transferase ... human progesterone receptor [PR-LBD(GST)] and a ...
Biology Products: