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:9/18/2014)... September 18, 2014 ... http://www.researchandmarkets.com/research/czvg3s/biocompatible ) has announced the addition ... Global Strategic Business Report" report ... ,This report analyzes the worldwide markets ... by the following Product Segments: Polymeric ...
(Date:9/18/2014)... Washington, D.C. (PRWEB) September 18, 2014 ... Dick Durbin and Sen. Jim Risch for National Lab ... research projects from across the national laboratory system. Durbin ... Caucus, which aims to increase awareness of the reach ... breakthrough technologies and discoveries to address some of our ...
(Date:9/18/2014)... 2014 Research and Markets ... N-acetylcysteine Industry Report 2014" report to their ... Report 2014 is a professional and in-depth study ... industry. The report provides a basic ... and industry chain structure. The N-acetylcysteine market analysis ...
(Date:9/18/2014)... , Sept. 18, 2014 Research ... "Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, ... report to their offering. The global ... CAGR of 22.7% from 2014 to 2019. Factors such ... growing adoption of companion diagnostics by the pharmaceutical industry, ...
Breaking Biology Technology:Biocompatible Materials - Global Strategic Business Report 2014 2Biocompatible Materials - Global Strategic Business Report 2014 3Lab Day Highlight Labs' Contribution to U.S. Competitiveness and Innovation 2Lab Day Highlight Labs' Contribution to U.S. Competitiveness and Innovation 3Global N-acetylcysteine Industry Report 2014 2Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, Immunohistochemistry) Market - Trends & Forecasts to 2019 2Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, Immunohistochemistry) Market - Trends & Forecasts to 2019 3
... Skills Related to Nutrition Care in Mosby,s ... Organization Elsevier/MC Strategies , a pioneer ... organizations announced today its collaboration with the American ... review and amend the nutrition-related skills in Mosby,s Nursing ...
... design, University at Buffalo chemists have synthesized tiny, molecular ... nanomaterials. , Sculpted from a special kind of molecule ... organic tubes whose interior walls carry a negative charge. ... positively charged particles. , In addition, because UB scientists ...
... Levi & Korsinsky is investigating potential claims on behalf ... California, Inc. ("PacBio" or the "Company") (NASDAQ: ... For more information, click here: http://zlk.9nl.com/pacific-biosciences-california-pacb/ ... that the Company failed to disclose the following: (a) ...
Cached Biology Technology:Elsevier Collaborates with the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) 2Elsevier Collaborates with the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) 3Chemists become molecular sculptors, synthesizing tiny, molecular traps 2Chemists become molecular sculptors, synthesizing tiny, molecular traps 3The Law Firm of Levi & Korsinsky, LLP Launches an Investigation Into Possible Securities Laws Violations by Pacific Biosciences of California, Inc. 2
(Date:9/18/2014)... ANTONIO, September 18, 2014 New research into the ... causes a severe hemorrhagic disease in humans similar to ... essential for CCHFV infection. This discovery has the potential ... the pathogen. , The research, reported in ... Pathogens and conducted by scientists at the Texas ...
(Date:9/18/2014)... researchers from McGill University and the Quebec government ... ,microbeads, Canadian Journal of Fisheries and Aquatic ... cosmetics, household cleansers, or industrial cleansers, to which ... their small size and buoyancy, they may readily ... a global contaminant in the world,s oceans, but ...
(Date:9/18/2014)... how many times it,s demonstrated, it,s still hard ... , But by using a signaling system called ... behavior to suit their population. In short, some ... and act accordingly. , Once the population of ... from innocuous to pathogenic, or from unhelpful to ...
Breaking Biology News(10 mins):Research milestone in CCHF virus could help identify new treatments 2Microplastic pollution discovered in St. Lawrence River sediments 2Researchers study vital 'on/off switches' that control when bacteria turn deadly 2Researchers study vital 'on/off switches' that control when bacteria turn deadly 3
... nannies help out, especially if they,ve been sneaking ... displays cooperative breeding behavior, where non-parents contribute to ... now, it was assumed that male subordinates never gained ... 12, in the online journal PLoS ONE , ...
... , This release is available in French ... Concordia University professors have received new funding to advance research ... of a peer committee, Canada Research Chairs were awarded to ... The announcement was made at Concordia in the ...
... of investigators from the University of Utah has received a ... to fund novel research that may help to uncover a ... multiple sclerosis. These studies will use an advanced technology called ... of primary progressive multiple sclerosis. Multiple sclerosis (MS), which ...
Cached Biology News:Recognition for 7 Concordia professors 2NIH grant will allow researchers to look for viral cause of most severe form of multiple sclerosis 2
...
... Perkin Elmer UltraVIEW system and want to enjoy ... iQ software? No problem. Our experienced team ... existing microscope, lasers, Sutter filter wheel, Piezo Stage ... with our precision controller unit and workstation... for ...
... The DNA Engine Dyad instrument is ... Featuring MJ's world-class thermal performance, ... color display, as well as point-and-click navigation ... The Dyad can be easily and economically ...
...
Biology Products: