Navigation Links
FDA Sets April 24, 2012 as PDUFA Goal Date for Cell Therapeutics' Resubmitted Pixantrone New Drug Application
Date:12/6/2011

sed or refractory NHL and/or other tumors as determined by the FDA and/or the EMA, that accelerated approval by the FDA of pixantrone may not occur, that CTI may not be able to address satisfactorily the two key matters raised by the OND or other matters raised by the DOP1, the OND and/or the FDA, that CTI's interpretation of the guidance provided by the OND, the DOP1 and/or the FDA may be different than the intent of the OND, the DOP1 and/or the FDA, that the OND, the DOP1 and/or the FDA may change its guidance, that the PIX301 study may not be deemed successful, that upon a re-review and/or resubmission of the NDA the FDA may find pixantrone to not be safe and/or effective, that the PIX301 study may still be deemed to be a failed study, that the FDA may require an additional clinical trial of pixantrone, that if CTI conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that CTI may not be able to provide satisfactory information in response to the CRL, that the FDA may not complete the review of the NDA by the PDUFA goal date of April 24, 2012, that the CHMP may not render an opinion on CTI's application for pixantrone with the EMA by January 19, 2012, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Media Contact:

Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: deramian@ctiseattle.com

Investors Contact:
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Alseres Pharmaceuticals, Inc. to Address a Congressional Briefing on Paralysis Research and the Spinal Cord Injury Community at Working 2 Walk in Washington, DC, April 13-15, 2008
2. ViroPharma to Release 2008 First Quarter Financial Results on April 30, 2008
3. April 16th Congressional Hearing on Hospital Infections
4. The COSHAR Foundation Launches National Childhood Immunization Awareness Campaign During National Infant Immunization Week (April 19-26)
5. PharmAthene to Host a Conference Call and Webcast on Wednesday, April 29th at 4:30 PM to Provide an Update on the SparVax(TM) rPA Anthrax Vaccine Program
6. FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA
7. 2nd Annual Orthopedic Design & Technology Forum Returns April 28 to the FedEx Institute of Technology, University of Memphis
8. Stryker to Host Conference Call on April 20, 2010
9. FDA Consumer Health Information - Generic Drug Roundup: April 2010
10. United Therapeutics Corporation To Announce First Quarter 2010 Financial Results Before Market Open on Thursday, April 29, 2010
11. CardioGenics to be Spotlighted in Three Publications During Month of April
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/1/2015)... --Research and Markets ( http://www.researchandmarkets.com/research/63gppw/asian_dermatology ) has announced ... Type, by End User - Forecast to 2019" report ... is estimated to grow at a CAGR of 11.3% from ... larger share in the Dermatology devices market around 28.8% in ... Dermatology Devices market holds a high potential for growth in ...
(Date:5/1/2015)... 1, 2015 At the American Association of ... Washington D.C. , Elekta will highlight ... clinicians to leverage the enormous amount of data – ... each year – to advance clinical research and further ... a cloud-based solution that allows practitioners to store, retrieve, ...
(Date:5/1/2015)... Pharmacyclics, Inc. (the "Company") (NASDAQ: PCYC ) today ... 2015, as well as general business updates. Due to ... be held. Key Highlights , Total ... to $206 million from $119 million for the quarter ... (ibrutinib) net product revenue of $247 million was ...
Breaking Medicine Technology:Asian Dermatology Devices (Treatment & Diagnostic) Market by Type, by End User - Forecast to 2019 2Asian Dermatology Devices (Treatment & Diagnostic) Market by Type, by End User - Forecast to 2019 3Elekta to showcase Leksell Gamma Knife Registry at AANS Annual Meeting 2Elekta to showcase Leksell Gamma Knife Registry at AANS Annual Meeting 3Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 2Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 3Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 4Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 5Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 6Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 7Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 8Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 9Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 10Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 11Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 12Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 13Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 14Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 15Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 16Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 17Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 18Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 19Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 20Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 21Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 22Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 23Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 24Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 25Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 26Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 27Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 28Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 29Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 30Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 31Pharmacyclics Reports First Quarter 2015 Financial Results and Provides Business Updates 32
... National Basketball Association (NBA), the Women,s National Basketball Association ... collaboration with the American Diabetes Association and Sanofi US, ... Dribble to Stop Diabetes campaign, a national multimedia ... healthy lifestyle and raise awareness about diabetes prevention, management ...
... Md., Jan. 26, 2012  Vanda Pharmaceuticals Inc. (NASDAQ: ... for the first time to reset the body clock ... in patients suffering from Non-24-Hour Sleep-Wake Disorder (Non-24-Hour Disorder).  ... treatment of Non-24-Hour Disorder in totally blind individuals with ...
Cached Medicine Technology:NBA, American Diabetes Association and Sanofi US Tip Off 2012 Dribble to Stop Diabetes Campaign 2NBA, American Diabetes Association and Sanofi US Tip Off 2012 Dribble to Stop Diabetes Campaign 3NBA, American Diabetes Association and Sanofi US Tip Off 2012 Dribble to Stop Diabetes Campaign 4Initial Clinical Data Reveal Potential of Tasimelteon to Reset the Body Clock in Non-24-Hour Sleep-Wake Disorder 2Initial Clinical Data Reveal Potential of Tasimelteon to Reset the Body Clock in Non-24-Hour Sleep-Wake Disorder 3Initial Clinical Data Reveal Potential of Tasimelteon to Reset the Body Clock in Non-24-Hour Sleep-Wake Disorder 4Initial Clinical Data Reveal Potential of Tasimelteon to Reset the Body Clock in Non-24-Hour Sleep-Wake Disorder 5
(Date:5/2/2015)... Vancouver fencing company, QS Fencing, has recently ... to prospective clients related to their questions on railings and ... around their decks and patios. While that seems like an ... once the person rolls up their sleeve to start working. ... in finding a gate that matches it. , Instead of ...
(Date:5/2/2015)... 2015 “ Peachtree Audio ” was ... Report, which features the latest and coolest technology products ... special reporter for NewsWatch, conducted the review and shared ... , Music is an important part of people’s ... and given the royal treatment. Peachtree Audio does just ...
(Date:5/2/2015)... May 02, 2015 With the success that ... is proud to welcome Neida Miranda and Alex Shields to ... Consulting has over 41 years of combined experience working with ... in the dental field for 8 years. She was ... Waco, Texas. Customer service, positive attitude and showing the importance ...
(Date:5/1/2015)... Royal River Natural Foods, a locally-owned independent natural ... study that found two natural nutrients, glucosamine and chondroitin, ... as well as standard drug treatment after six months ... The report is part of the May 2015 issue ... Royal River Natural Foods publishes for free each month ...
(Date:5/1/2015)... May 01, 2015 Ernst & Young ... Joshua Rosenthal, Co-Founder & CSO, and Burak Sezen, Co-Founder ... the EY Entrepreneur Of The Year® 2015 Awards ... Young is a global leader in assurance, tax, ... be one of the top audit companies in the ...
Breaking Medicine News(10 mins):Health News:Professional Staff at QS Fencing Company Now Provides Advice on Railings and Gates 2Health News:Affordable High-End Audio Equipment was Featured on NewsWatch Television 2Health News:Veatch Dental Consulting Services Welcomes New Team Members 2Health News:New Study Finds Nutrients Ease Arthritis Pain, Retailer Reports 2Health News:RowdMap, Inc. Named as a Ernst & Young Entrepreneur Of The Year® 2015 Award Finalist 2
... ... Surgery indicate breast augmentation has surpassed liposuction after years of dominance as the number-one ... Straka makes breast surgery procedures a main focus of his practice, in addition to ... , ...
... ... in new grants to assist Medicare beneficiaries in need of information on a wide ... ... 2009 -- In an effort to assist California Medicare beneficiaries to obtain better, more ...
... Susan Lark, MD, ... searchhearthealth.com, a new informational Web site devoted to all aspects of heart health. , ... Potomac, MD (Vocus) July 20, 2009 ... is now a featured expert on searchhearthealth.com, a new informational Web site devoted to all ...
... July 21 Following is the daily "Profile America" feature ... http://www.newscom.com/cgi-bin/prnh/20090226/CENSUSLOGO ) , , ... - Tuesday, July 21st. On the one hand, there,s ... diet of many Americans, underlined by pronouncements of anxiety from ...
... , , , ... ) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from ... Application (ANDA) for Haloperidol Tablets USP, 10 mg and 20 mg. These strengths ... and 5 mg strengths of the product. , , ...
... therapies should be the standard of care for all HIV-infected ... resources, according to a study led by researchers at Massachusetts ... of Cape Town, South Africa. The team reports in ... starting antiretroviral therapy (ART) when the level of CD4 ...
Cached Medicine News:Health News:Nation's Most Popular Cosmetic Surgery Procedure is a Way for One Houston Plastic Surgeon to Renew Body Contours and Self-Esteem 2Health News:Nation's Most Popular Cosmetic Surgery Procedure is a Way for One Houston Plastic Surgeon to Renew Body Contours and Self-Esteem 3Health News:California Health Insurance Assistance Program Awarded 2009 Grant Funding, Says MedicareSupplementPlans.com 2Health News:Women's Health Expert Dr. Susan Lark Featured on Searchhearthealth.com 2Health News:Earlier HIV antiviral treatment can be cost effective in areas of limited resources 2
... remote monitoring service allows the the ... monitored from any location via modem ... enhances preventive maintenance capabilities. Thermo ... unit (with your permission) from their ...
Shandon HistoWave is the answer to rapid tissue processing. It reduces time for fixation, tissue processing, decalification, immunochemistry and special stains....
... Grossing Wokrstation is a durable, safety-driven, ... gross examination and sectioning of specimens. ... efficient ventilation systems and options of ... faucets, table rinses, disposals and dictation ...
The Shandon Grosslab Grossing Workstation comes in a bench top or stand alone design for the gross examination and sectioning of specimens....
Medicine Products: