Navigation Links
FDA Grants Fast Track Designation to CTI BioPharma's Pacritinib, a Novel JAK2 Inhibitor for the Treatment of Myelofibrosis
Date:8/6/2014

SEATTLE, Aug. 7, 2014 /PRNewswire/ --CTI BioPharma Corp. (CTI or the Company) (NASDAQ and MTA: CTIC) announced today that pacritinib has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are sub-optimally managed on other JAK2 therapy. Pacritinib is an oral tyrosine kinase inhibitor with dual activity against JAK2 and FLT3. The drug candidate is currently being evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients with myelofibrosis.

"We are very pleased that the pacritinib development program in myelofibrosis has been granted Fast Track designation, and we look forward to continuing to work closely with the FDA on this important drug candidate," stated James A. Bianco, M.D., President and CEO. "We believe that pacritinib's unique profile has the potential to serve an unmet medical need that currently exists in this patient population, particularly for those patients with disease or therapy-related low platelet counts."

The Fast Track process is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. An unmet need is a condition whose treatment or diagnosis is not addressed adequately by available therapy. The purpose of the Fast Track designation is to make important new drugs available to the patient earlier. The Fast Track program also enables a company to submit sections of the NDA on a rolling basis as data becomes available. This enables the FDA to review sections of the NDA as they are received, rather than waiting until every section of the application is completed before the enti
'/>"/>

SOURCE CTI BioPharma
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. PTC Therapeutics Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
2. US Patent Office Grants McCord Research Endothelial Cell Treatment Patent
3. FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Candidiasis
4. FDA Grants Orphan Drug Designation to Omeros OMS721 for Complement-Mediated Thrombotic Microangiopathies
5. FDA Grants Approval of IND to Commence a Phase 3 Pivotal Study for ST10 for the Treatment of Iron Deficiency Anaemia in Chronic Kidney Disease
6. Auxilium Pharmaceuticals, Inc. Announces Court Grants Upsher-Smith Laboratories Motion For Summary Judgment
7. FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Aspergillosis
8. RadSite Grants Accreditation to First Wave of MIPPA Program Applicants
9. NASDAQ Grants China Jo-Jo Drugstores 180-Day Extension to Regain Compliance with Bid Price Requirement
10. U.S. FDA Grants Orphan Drug Designation for KaloBios KB001-A in Treatment of Cystic Fibrosis Patients
11. FDA Grants 510(k) Clearance for Innovative Fuse Gastroscope from EndoChoice
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... Dec. 19, 2014 Breckenridge Pharmaceutical, Inc. announced ... with MSN Laboratories Pvt. Ltd. ( Hyderabad, India ... commercialize several new ANDAs.  Under the terms of the ... exclusively to Breckenridge for the U.S. market, and Breckenridge ... Breckenridge and MSN have agreed to develop an oral ...
(Date:12/19/2014)... , Dec. 19, 2014 In today,s ... product,s web presence to reflect the needs of ... particular, must meet the needs of key stakeholders ... According to recent research by ... of the participating companies averaged more than $100,000 ...
(Date:12/19/2014)... , Dec. 19, 2014  Monarch America Inc. ... Kinetics Corp.) is pleased to provide this review of ... growth in 2015. "Over this past year, ... and I am extremely proud to say that Monarch ... today than it has ever been," stated Eric ...
Breaking Medicine Technology:Breckenridge Pharmaceutical signs Multi-Product Generic Agreement with MSN Laboratories Pvt. Ltd. 2Building a Best-in-Class Pharma Global Brand Website 2Monarch America Inc. CEO Reviews Recent Achievements and Provides Outlook for 2015 2Monarch America Inc. CEO Reviews Recent Achievements and Provides Outlook for 2015 3
... In honor of Epilepsy Awareness Month, global biopharmaceutical ... Epilepsy Advocates to "start a revolution," by inspiring people ...  As part of this effort, UCB will roll out ... called "Army of Advocates" and two new Epilepsy Advocate ...
... to an end on Sunday, Nov. 6, and adjusting the clock ... that they experience a sleep problem every night or almost every ... poll, and for those individuals the time change can further disrupt ... for not only an extra hour, but stay asleep longer and ...
Cached Medicine Technology:Epilepsy Awareness Month Begins Now: Start Your Revolution! 2Epilepsy Awareness Month Begins Now: Start Your Revolution! 3Epilepsy Awareness Month Begins Now: Start Your Revolution! 4Keep the Time Change From Disrupting Your Rest With Sleep Formula 39™ 2
(Date:12/20/2014)... 20, 2014 Dress company LunaDress has recently ... announced its Christmas Sale, offering big discounts on all of ... has an idea to own a perfect wedding gown. If ... wedding dress, then come to LunaDress. Many different wedding dress ... Visit our website now and enjoy the current special offer, ...
(Date:12/20/2014)... 20, 2014 (HealthDay News) -- The holidays can be ... contend with fresh trees, scented candles and other allergy ... the decorations that have been packed away in dank ... allergy and asthma patients," Dr. Rachna Shah, an affiliate ... Medicine, said in Loyola news release. Shah, who ...
(Date:12/20/2014)... (PRWEB) December 20, 2014 Angeldress.co.uk, the ... something great for worldwide dress fans. The company has ... news and information. For the holiday season, Angeldress ... about special wedding apparel. , Angeldress.co.uk prides itself in ... unsurpassed level of service. All the company’s outfits are ...
(Date:12/20/2014)... The aftermath of the November 24th hack on ... in Hollywood, but worldwide. As reported in the ... that attack are starting a finger-pointing game which could put ... they are not the only ones affected, regular employees who ... embarrassing times ahead, agents and lawyers could be in for ...
(Date:12/20/2014)... OH (PRWEB) December 20, 2014 ... contend they suffered uncontrollable bleeding and other serious ... Court, Eastern District of Louisiana for coordinated pretrial proceedings, ... on Multidistrict Litigation (JPML) issued an order Friday to ... actions pending in 22 federal courts to the Louisiana ...
Breaking Medicine News(10 mins):Health News:2015 Collection of Wedding Dresses from LunaDress Online on Sale Now 2Health News:Holiday Trimmings Can Trigger Allergies 2Health News:Trendy Professional Wedding Apparel Recommended by Angeldress Blog 2Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 2Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 3Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 4Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 5Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 2Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 3Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 4
... organisation, the Ashodya Mahila Samanwayas Samithi (AMSS), is launching a ... Mysore district. ,As many as 500 sex workers ... in ,A first time in the country this scheme is ... the smart cards. The smart card project, the brainchild of ...
... across the world and it has drastically affected the sales of ... demand for chicken// and the sales are slowly picking up in ... recuperation stage. ,Mohamed Al Shafei, director of the General ... a great deal in the past with a large number of ...
... of a lobster commonly known as Tomalley, is considered by ... waste//, unhealthy product. The health agency of Canada has decided ... lobster tomalley. ,The health agency has announced that ... pancreas for lobster, can sometimes contain a toxin known as ...
... blaming wild birds, as the cause of H5N1 virus or bird ... Organization (FAO). ,A dreadful disease caused by viruses ... even infect and deaths in poultry and humans. ... to be done regarding bird flu in future years, but now ...
... on music therapy found that up to 21% of chronic ... music therapy//. ,Music listening, controls pain and makes ... ,About 60 people, with an average age of 50, ... the controlled clinical trial run by team of researchers. ...
... today stepped up their anti-reservation stir with faculty members ... // and the medical fraternity gearing up for a ... got a boost as students of the prestigious Jawaharlal ... Delhi began a relay hunger strike at their campuses ...
Cached Medicine News:Health News:Sex Workers To Have Smart Health Card 2
... The ROYAL™ single-use skin stapler places one ... The staples first penetrate the skin and are ... skin staples are available in two sizes: wide ... closure) and regular (having a clip span of ...
... CONCORDE staplers place one staple ... are activated. The staples first ... then formed, thus holding the ... staple sizes, each contained in ...
... PROXIMATE Skin Staplers place single ... are made of lubricant-coated stainless steel; ... Endo-Surgery makes three different skin staplers ... skin stapler has applications for routine ...
... articulating (22° and 45° in both directions) ... resection, transection and anastomosis for open surgery ... two triple-staggered rows of staples and simultaneously ... The instrument is designed for multiple use ...
Medicine Products: