Navigation Links
Pharmacyclics First to Announce Breakthrough Therapy Designation in Oncology from the U.S. Food and Drug Administration
Date:2/12/2013

" said Bob Duggan , CEO and Chairman of the Board. "This compound entered the clinic in 2009 and has demonstrated tremendous clinical progress over the past four years. I would like to thank our collaboration partner, Janssen, for their support. Together we are committed to bringing this new therapeutic to patients and health care providers."

Dr. Ellen Sigal , Chair & Founder of Friends of Cancer Research, a think tank and advocacy organization based in Washington, D.C., said, "As an oncology product, ibrutinib receiving the Breakthrough Therapy Designation is an example of progress and hope for patients fighting a range of cancers. This designation shows that the FDA is dedicated to using an 'all hands on deck approach' to work on products that show promise in treating serious and life-threatening diseases. The breakthrough pathway that our organization worked to create is intended to speed up the development and review of treatments that may demonstrate substantial improvement over existing therapies, and ibrutinib is a great example of using this new designation to potentially accelerate patient access to promising treatments."

The FDA Breakthrough Therapy Designation for ibrutinib in MCL patients was based on data from clinical and pre-clinical studies. Ibrutinib has the potential to improve the outcome in this serious and life-threatening disease which has a poor prognosis. The company and Janssen have designed a comprehensive development program of ibrutinib in MCL which includes the following studies:
- A Phase III randomized, multi-center registration trial of ibrutinib as a monotherapy versus temsirolimus in relapsed or refractory MCL patients who received at least one prior rituximab-containing chemotherapy regimen, RAY (MCL3001).
- A Phase III randomized, double-blind, placebo-controlled study of ibrutinib plus bendamustine and rituximab
'/>"/>

SOURCE Pharmacyclics, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Pharmacyclics Announces Date of Financial Results for Three and Six Months Ended December 31, 2012 and Conference Call
2. Pharmacyclics Reports Fourth Quarter and Full Year Fiscal 2012 Financial Results and Recent Developments
3. Pharmacyclics Announces Oral Presentations of Ibrutinib (PCI-32765) at the 17th Congress of the European Hematology Association
4. Pharmacyclics Announces Oral Presentations and Clinical Update of Ibrutinib (PCI-32765) at the 2012 Annual Meeting of the American Society of Clinical Oncology
5. Landauer, Inc. Reports Fiscal 2013 First Quarter Results
6. Misonix Reports Financial Results for First Half of Fiscal 2013
7. CareFusion Reports First Half Fiscal 2013 Results
8. Avanir Pharmaceuticals Reports Fiscal 2013 First Quarter Financial And Business Results
9. American Pacific Reports Fiscal 2013 First Quarter Results; Reaffirms Full Year Guidance
10. European patient registry in venous thromboembolism (VTE) - PREFER in VTE - enrols first patient
11. Neutronic Ear Introduces Worlds First Rechargeable-Powered Hearing Device
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... BURLINGTON, Mass. , Sept. 30, 2014  Decision ... (PV) devices in Brazil , ... and China (BRIC) will see ... techniques are increasingly favored over surgical procedures. Although revenues ... care resources, reimbursement challenges, prolonged device approval times and ...
(Date:9/30/2014)... Sept. 30, 2014   Easy Breathe , the ... today announced that it now offers the revolutionary ... are the first sleep apnea therapy devices with internal ... easy to track and share real-time data on each ... their CPAP therapy.  In addition, the internal modem allows ...
(Date:9/30/2014)... 30, 2014  HealthLoop® released an app version of ... iOS 8 and allows people to share medical device ... native iOS technologies to enhance the HealthLoop experience for ... with their doctors between visits. "This ... they collect is exciting," says HealthLoop founder Dr. ...
Breaking Medicine Technology:Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 2Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 3Easy Breathe Now Offers World's First "Smart" CPAP Device to Treat Sleep Apnea 2Easy Breathe Now Offers World's First "Smart" CPAP Device to Treat Sleep Apnea 3Easy Breathe Now Offers World's First "Smart" CPAP Device to Treat Sleep Apnea 4HealthLoop Integrates with Apple's HealthKit Enabling Patients to Share Health Data with Their Doctors Right from their iPhone 2
... BRUNSWICK, N.J., Dec. 14, 2010 The Dr. ... its 2011 call for nominations. This prestigious award ... has the potential to make, significant transformational contributions ... available at www.pauljanssenaward.com and will be ...
... Calif., Dec. 14, 2010 Samplify Systems, Inc., ... for the ultrasound market, is pleased to announce ... imaging has won Electronic Design Magazine,s ... medical category.  Details of Samplify,s AutoFocus™ beamforming technology ...
Cached Medicine Technology:Dr. Paul Janssen Award for Biomedical Research Issues Call for Nominations 2Dr. Paul Janssen Award for Biomedical Research Issues Call for Nominations 3Samplify's AutoFocus™ Beamforming Technology Awarded Electronic Design's 'Best of 2010' 2
(Date:9/30/2014)... Federally Qualified Health Centers (FQHCs) granted new ... at higher rates than other primary care practices ... according to results of a new 10-state University ... Medical Care . , Using data from a ... 2013, the investigators found that FQHCs community ...
(Date:9/30/2014)... 30, 2014 EverStryke , the permanent ... to SurvivalLife.com along with a free book and class all ... Shane Michaels, prompting an investigative review. , “Joe Marshall ... the survival and preparation niche, and this product is an ... classes and survival products that Joe offers on his website ...
(Date:9/30/2014)... Minn. (PRWEB) September 30, 2014 For ... to the apple orchard, pumpkin patch or annual festival. ... for fast-spreading viruses – like the respiratory infection Enterovirus ... in most children, a small percentage – especially children ... symptoms. Increased concern about the Enterovirus is prompting hospitals ...
(Date:9/30/2014)... TOWNSHIP, Mich. (PRWEB) September 30, 2014 ... chronic knee pain program of care that ... , His clinic—Johnson Chiropractic Neurology & Nutrition—applies ... on the knee. It also addresses sources of inflammation, ... well as the “neurokinetic chain” from the brain to ...
(Date:9/30/2014)... has made progress in reducing the stigma associated with ... post-traumatic stress disorder, but more improvement is still needed, ... efforts of both the Defense Department and the Veterans ... members still do not seek needed care for ... effort to promote treatment as a way to reduce ...
Breaking Medicine News(10 mins):Health News:Medicaid and Uninsured patients obtain new patient appointments most easily at FQHCs 2Health News:EverStryke: Review Exposes Joe Marshall’s Permanent Match Survival Product 2Health News:As Hospitals Combat Enterovirus Outbreaks, Patients and Families Turn to “Virtual Visits” with CaringBridge 2Health News:Newly Developed Program Eases Chronic Knee Pain without Surgery and in as Little as Two Days 2Health News:Newly Developed Program Eases Chronic Knee Pain without Surgery and in as Little as Two Days 3Health News:US military making progress reducing stigma tied to seeking help for mental illness 2Health News:US military making progress reducing stigma tied to seeking help for mental illness 3
... Cornwall Primary Care Trust (PCT) has revealed that patients who ... as it lacks the funds for non-urgent cases//. The Royal ... not permit himself to be forced to follow the new ... for patients. ,He feels that a waiting list ...
... stroke, three leading killers in the U.S., all dropped in ... ,Also, Americans' life expectancy increased again in 2003, up ... in 1990. ,Life expectancy in the U.S. has ... including advances in medicine and sanitation, and declines in unhealthy ...
... which are proved to be better than older drugs ... benefit of these drugs could be realized reports//, Medicine ... Frontiers) have accused the pharmaceutical companies that they are ... providing AIDS treatment to over 57,000 people in 29 ...
... caused the death of a 5 year old boy in Thailand ... is not found to be in direct contact with chickens, but ... the neighboring poultry. ,The latest good news to ease ... the patent for Tamiflu drug has given permission to manufacturers to ...
... overweight people—they cannot reduce weight by exercise due to ... often prescribe exercise as part of a regime to ... psychologist Rona Levy at the University of Washington have ... hampered by a variety of gastrointestinal problems that frequently ...
... be a stimulation to be relieved as survivors have ... ,This arises due to its treatment and or shared ... population. ,According to the study the most likely ... cancer, renal cancer, thyroid cancer, soft tissue sarcoma, endometrial ...
Cached Medicine News:Health News:US life expectancy climbs to a new high 2
... Pressure Assessment and Management System provides a ... blood pressure and other key cardiovascular data, ... and management of patients. , ,Using a ... the ascending aortic blood pressure waveform from ...
... with BD Xstar Blade includes a specially ... blade in prodedure and handling. The ... grind-less process for manufacturing surgical blades. ... consistency. The arch style, single-bevel geometry ...
A system for all indications, can be used with the OrthoPilot surgical navigation system....
Electric high speed system....
Medicine Products: