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

EMERYVILLE, Calif., Jan. 31, 2011 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that the U.S. Food and Drug Administration (FDA) has granted fast track designation for carfilzomib, a next generation proteasome inhibitor for the potential treatment of patients with relapsed and refractory multiple myeloma. The Fast Track designation process was developed by the FDA to facilitate the development, and expedite the review of drugs to treat serious or life-threatening diseases and address unmet medical needs.  Positive complete results from the Phase 2b 003-A1 study evaluating single-agent carfilzomib in patients with relapsed and refractory multiple myeloma were recently announced at the American Society of Hematology (ASH) meeting in December 2010.

Based on these results, Onyx has initiated a rolling submission of a New Drug Application (NDA) for potential accelerated approval of carfilzomib in the U.S. Through the Fast Track designation, Onyx is eligible to submit the carfilzomib NDA on a rolling basis, allowing Onyx to begin the NDA filing process immediately and giving the FDA an opportunity to review the completed sections of the registration application. Onyx has now submitted the non-clinical section of the carfilzomib NDA with the FDA and commenced its rolling NDA process. Onyx intends to complete its submission of the NDA for potential accelerated approval of carfilzomib in the U.S. as early as mid-2011.

"The FDA's Fast Track designation recognizes the significant need for new treatment options for patients," said Ted Love, M.D., executive vice president, research and development and technical operations at Onyx. "We look forward to continuing to work with the FDA on the regulatory review and further development of carfilzomib, which has demonstrated encouraging response rates and tolerability in patients with advanced multiple my
'/>"/>

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:8/22/2014)... Albany, New York (PRWEB) August 22, 2014 ... represent one of the interesting and challenging endeavors ... eye renders highly impervious properties to the foreign ... such as possibility of self medication and minimal ... of low molecular weight drugs and provides specific ...
(Date:8/22/2014)... Los Angeles (PRWEB) August 22, 2014 ... for age-defying products, is in the spotlight again. ... night cream and its NeriumFirmTM Body Contouring Cream ... presented by Backstage Creations during the 66th Primetime ... the patented NAE-8® extract, third-party clinical trials show ...
(Date:8/21/2014)... the Institute for Molecular Medicine Finland (FIMM), University ... a novel "man and machine" decision support system ... was described in PLOS One scientific ... on computer vision algorithms similar to those used ... only the diagnostically most relevant areas. Tablet computers ...
(Date:8/21/2014)... 21, 2014 Telomere Biosciences, LLC (Telomere ... "TELO-20 for Dogs" with Telomerase Activation Complex ... the world for dogs. Telomeres are the protective ... the body. A wealth of ground-breaking research by ... Science and Aging, including Nobel laureates, has demonstrated ...
Breaking Biology Technology:Ocular Drug Delivery Technologies Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Ocular Drug Delivery Technologies Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3Ocular Drug Delivery Technologies Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 4Nerium International Joins Television’s Biggest Stars at Backstage Creations Giving Suite at the 66th Primetime Emmy Awards 2Nerium International Joins Television’s Biggest Stars at Backstage Creations Giving Suite at the 66th Primetime Emmy Awards 3A novel 'man and machine' decision support system makes malaria diagnostics more effective 2Telomere Biosciences Announces: TELO-20 for Dogs, the World's First Telomere-Lengthening Supplement for Dogs, to Promote Healthy Aging and Longevity 2Telomere Biosciences Announces: TELO-20 for Dogs, the World's First Telomere-Lengthening Supplement for Dogs, to Promote Healthy Aging and Longevity 3
... of decorative, flower-like defects in the nanomaterial graphene could ... electrical and mechanical properties, according to researchers at the ... Tech. In a new paper,* the team for the ... could occur naturally or be induced to occur in ...
... of the March 11 earthquake and rolling blackouts that ... award-winning undergraduate internship program NanoJapan is scrambling to run ... U.S. undergraduates travel to Japan for lab internships, NanoJapan ... send 25-30 students to Rice University laboratories for three ...
... May 25, 2011 Anadys Pharmaceuticals, Inc. (Nasdaq: ... the treatment of hepatitis C, announced today that it will ... the Company,s oral immuno-modulator that acts via the TLR-7 pathway, ... Meeting in Chicago, IL.  The data from the completed Phase ...
Cached Biology Technology:Defect in graphene may present bouquet of possibilities 2Reverse NanoJapan: Rice to host 25-30 Japanese students 2Anadys Highlights ANA773 Data to be Presented at ASCO 2Anadys Highlights ANA773 Data to be Presented at ASCO 3Anadys Highlights ANA773 Data to be Presented at ASCO 4
(Date:8/21/2014)... Aug. 21, 2014 Nxt-ID, Inc. (OTCQB: NXTD), ... commerce market, announced today that its shares of common ... be issued in its proposed underwritten public offering of ... on The Nasdaq Capital Market, subject to closing of ... and warrants, and will trade under the symbol "NXTD" ...
(Date:8/21/2014)... ubiquitous skin fungus linked to dandruff, eczema and other ... to even further global reachesincluding Hawaiian coral reefs and ... vents. , A review in the scientific journal ... of the fungi of the genus Malassezia ... sequencing datasets from around the world. , University of ...
(Date:8/21/2014)... -- Nine researchers from Beth Israel Deaconess ... in "The World,s Most Influential Scientific Minds 2014," ... Thomson Reuters ScienceWatch, a web resource for science metrics ... recognized as among the most influential "are performing and ... the advancement of their science," according to a Thomson ...
Breaking Biology News(10 mins):Nxt-ID Approved for NASDAQ Capital Market Listing 2Nxt-ID Approved for NASDAQ Capital Market Listing 3From dandruff to deep sea vents, an ecologically hyper-diverse fungus 2BIDMC researchers named among 'the most influential scientific minds' 2BIDMC researchers named among 'the most influential scientific minds' 3
... commercially available mineral waters, the researchers found evidence of ... the water. What,s more, these chemicals are potent in ... in the New Zealand mud snail. These findings, which ... of plastic food packaging materials act as functional estrogens, ...
... diseases that can travel with the wind have the ... understood, according to a new study, in findings that ... but also a new fungus that threatens global wheat ... State University and other institutions, concluded that invading diseases ...
... is available in Spanish . , ... of psychosis and schizophrenia, and those episodes of psychosis ... characteristics, both before their appearance and in the clinical ... conclusions of the doctoral thesis "Neurodevelopment and environmental stress ...
Cached Biology News:Hormone-mimics in plastic water bottles -- just the tip of the iceberg? 2New wheat disease could spread faster than expected 2New wheat disease could spread faster than expected 3Daily consumption of cannabis predisposes to the appearance of psychosis and schizophrenia 2
... The CHEMICON APO-BRDU Kit is ... labeling DNA breaks and total cellular DNA ... The kit contains the instructions and ... including; positive and negative control cells for ...
... overlay agarose, is a low melting point ... to secure IPG strips in place for ... incorporated to allow monitoring of electrophoresis runs. ... melting point agarose in 1x Tris, glycine, ...
... cell is an apparatus dedicated to general ... agarose slab gels. The cell includes the ... tray, 5 glass plates, 50 sheets of ... templates, and instructions. Dimensions are 21 x ...
... range of next-generation features into a small-footprint ... for flexible laboratory solutions. It puts every ... dilution, dispensing, and integrations into a ... flexible as it is efficient and economical. ...
Biology Products: