Navigation Links
Pharmacyclics Reports First Quarter 2013 Results
Date:5/1/2013

hromosome 17p.

The Breakthrough Therapy Designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases where "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development." The designation of a drug as a Breakthrough Therapy was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act. Pharmacyclics, together with Janssen, is working with the FDA to determine the implications of this Breakthrough Therapy Designation to the ongoing and planned development and the filing requirements for the use of ibrutinib in patients. At this time Pharmacyclics is targeting to submit the MCL filing before the end of the third quarter 2013. Pharmacyclics anticipates to provide guidance prior to year end on the WM and CLL with deletion 17p filing timelines after further discussions with the FDA.

The FDA Breakthrough Therapy Designations for ibrutinib were based on data from clinical and pre-clinical studies. Ibrutinib has the potential to improve the outcome in these serious and life-threatening diseases which have a poor prognosis. The company and its collaboration partner, Janssen, have designed and are currently executing a development program for ibrutinib in each of these indications.

Comprehensive Pre-Clinical Research and Clinical Development To broaden our understanding of ibrutinib, Pharmacyclics has performed research into mechanisms of action both in its own research department, and through collaborations with leading universities and clinical centers. Over the past 3 years, Pharmacyclics' research department has established and maintained 47 collaborations with academic investigators at universities or clinical centers. This broad-reaching collaborative effort has resulted
'/>"/>

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

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Related medicine technology :

1. Pharmacyclics Announces Date of Financial Results for Three Months Ended March 31, 2013 and Conference Call
2. Pharmacyclics Triggers Fourth Milestone Payment for Enrollment of 5th Patient in Frontline Phase III CLL Study
3. Pharmacyclics Announces Third Breakthrough Therapy Designation for Ibrutinib from the U.S. Food and Drug Administration
4. Pharmacyclics, Inc. Prices Public Offering of Common Stock
5. Pharmacyclics, Inc. Announces Proposed Public Offering of Common Stock
6. Pharmacyclics First to Announce Breakthrough Therapy Designation in Oncology from the U.S. Food and Drug Administration
7. Pharmacyclics Announces Date of Financial Results for Three and Six Months Ended December 31, 2012 and Conference Call
8. Pharmacyclics Reports Fourth Quarter and Full Year Fiscal 2012 Financial Results and Recent Developments
9. Pharmacyclics Announces Oral Presentations of Ibrutinib (PCI-32765) at the 17th Congress of the European Hematology Association
10. Pharmacyclics Announces Oral Presentations and Clinical Update of Ibrutinib (PCI-32765) at the 2012 Annual Meeting of the American Society of Clinical Oncology
11. Hospira Reports First-Quarter 2013 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... , Jan. 14, 2014  Luminex Corporation (Nasdaq: ... for the fourth quarter of 2013 on Monday, February 3, ... release after the close of trading. (Logo: ... call to discuss the operating highlights and financial results for ...
(Date:1/14/2014)... , Jan. 14, 2014 /PRNewswire-iReach/ -- Acumed,s new SLIC ... guide with accompanying instrumentation to place and insert the ... the soft tissue (e.g. ligament) repair or reconstruction as ... heals. (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) ...
(Date:1/14/2014)... VALHALLA, N.Y. , Jan. 14, 2014   Oligomerix, Inc. ... disease modifying therapeutics for Alzheimer,s disease (AD) and related ... headquarters to Valhalla, NY as ... additional laboratory space at New York Medical College. ...
Breaking Medicine Technology:Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3Oligomerix Relocates Corporate Headquarters and Secures Additional Laboratory Space from New York Medical College 2
... Mich., June 17 GeneGo, Inc., a leading,provider ... announced,today that they were awarded a Phase I ... of a platform for functional data analysis in,cancer. ... Boston on the project. The system, MetaMiner (Oncology) ...
... SYDNEY, Australia, June 16 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis,(ASX: PXS; ... Limited to,manage and provide eligible patients worldwide with ... The program will allow patients who are unable ... are considered by their physician,to be suffering from ...
Cached Medicine Technology:GeneGo is Awarded NCI Grant for Development of Systems Biology Platform for Integrative Data Analysis in Cancer 2Pharmaxis Establishes Named Patient Program for Bronchitol 2
(Date:7/10/2014)... decades, health-conscious people around the globe have taken antioxidant ... was one of the paths to good health and ... of antioxidant supplements have repeatedly dashed the hopes of ... risk. Virtually all such trials have failed to ... in several trials antioxidant supplementation has been linked with ...
(Date:7/10/2014)... could prove useful in treating small cell lung cancer - ... the Cancer Research UK Manchester Institute, based at The University ... teamed up with experts at AstraZeneca, as part of a ... as AZD3965 - on small cell lung cancer cells. , ... , also helps identify which patients are most likely to ...
(Date:7/9/2014)... sudden, acute episodes of low back pain are not ... pressure, wind direction and precipitation. Findings published in ... American College of Rheumatology (ACR), indicate that the risk ... speed or wind gusts, but was not clinically significant. ... nearly everyone experiences low back pain at some point ...
(Date:7/9/2014)... After Susan Wakulich was told she had an aneurysm, ... ahead of her. , "I was devastated," said Wakulich, who ... "I knew this was a serious diagnosis. Then I met ... that involved a less invasive procedure. It was something I ... participating in a multi-center U.S. clinical trial to evaluate the ...
(Date:7/9/2014)... the metabolism of stromal support cells and immune cells ... cell types in the development of diseases could ... cancer. That was the conclusion of a review article ... leading journal Nature . , Prof. Peter Carmeliet: ... The metabolism of cancer cells has been examined in ...
Breaking Medicine News(10 mins):Health News:How antioxidants can accelerate cancers, and why they don't protect against them 2Health News:New drug active against most aggressive type of lung cancer cells 2Health News:Low back pain? Don't blame the weather 2Health News:New type of stent could help some brain aneurysm patients 2Health News:Wake-up call for more research into cell metabolism 2
... difficile Inpatients on Any One Day; Patients,Dispersed Across ... The life-threatening,bacterium that causes diarrhea and more serious ... than previously,estimated, according to a new study released ... and Epidemiology (APIC)., "The National Prevalence Study ...
... web site by pilots, for pilots, www.wings4aviators.com , custom-embroiders U.S. ... To honor veterans, the company is donating 10% of the proceeds ... 501(c)(3) charity. , ... Hartland, WI (PRWEB) November 11, ...
... nursing, The Magnet Prize, was awarded to Abington Memorial Hospital (AMH) for ... Lake City, UT. This was the sixth year the award was ... ... the most prestigious awards in nursing, The Magnet Prize, was awarded to ...
... to helping seniors and their families understand their Medicare benefits ... hosting eight "Knowing Your Medicare Benefits for 2009" comparison presentations ... ... Torrance, CA (PRWEB) November 11, 2008 ...
... recognized as one of the top performing California physician groups by ... is one of only four California Physicians groups in the greater ... ... (PRWEB) November 11, 2008 -- This is the fifth straight year ...
... unveils TX11: a mobile computing cart designed to accommodate most laptop ... ... -- The Columbus, OH based medical product developer, Artromick, announced that ... mobile computing carts : the TX11 Medserver. While all Artromick ...
Cached Medicine News:Health News:Intestinal Infection Afflicts 13 of 1,000 Hospital Patients, Infection Rates 6.5 - 20 Times Greater Than Previous Estimates, New Study Says 2Health News:Intestinal Infection Afflicts 13 of 1,000 Hospital Patients, Infection Rates 6.5 - 20 Times Greater Than Previous Estimates, New Study Says 3Health News:New Web Site Offers Shirts with Custom-embroidered Aviator Wings for Veteran Military Pilots, Supports Families of the Wounded Fund 2Health News:New Web Site Offers Shirts with Custom-embroidered Aviator Wings for Veteran Military Pilots, Supports Families of the Wounded Fund 3Health News:New Web Site Offers Shirts with Custom-embroidered Aviator Wings for Veteran Military Pilots, Supports Families of the Wounded Fund 4Health News:Abington Memorial One of Just Six Hospitals in the U.S. to Win Magnet Prize 2Health News:Abington Memorial One of Just Six Hospitals in the U.S. to Win Magnet Prize 3Health News:Healthcare Partners Medical Group to Host Free Medicare Benefits Presentations 2Health News:Healthcare Partners Medical Group to Host Free Medicare Benefits Presentations 3Health News:Healthcare Partners Medical Group to Host Free Medicare Benefits Presentations 4Health News:HealthCare Partners Rated A 'Top Performing California Physician Group' By IHA For the Fifth Straight Year 2Health News:HealthCare Partners Rated A 'Top Performing California Physician Group' By IHA For the Fifth Straight Year 3Health News:Mobile Computing Carts Leader to Release New Clinical Computer Cart 2
Mac Pherson titanium tying forceps are ergonomic, very thin, angled with tying platforms. Round ergonomic design for great balance and feel. Fine platforms excellent for tying 10-0 suture....
Fine tying forceps, standard with smooth jaws. For 7-0 to 9-0 sutures....
Harms tying forceps, standard, straight with smooth jaws. For 7-0 to 9-0 sutures....
Tennant stainless steel tying forceps is extra delicate, straight with smooth jaws, 6 mm long platform, round handle with guide pin. For 9-0 to 11-0 sutures....
Medicine Products: