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

SUNNYVALE, Calif., Feb. 12, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the investigational oral agent ibrutinib monotherapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) and to ibrutinib monotherapy for the treatment of patients with Waldenstrom's macroglobulinemia (WM), both of which are B-cell malignancies.

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."[i]  The designation of a drug as a Breakthrough Therapy was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act.

Pharmacylics, 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 with MCL and WM. The company expects to finalize the MCL filing prior to year end and will provide guidance on the WM filing after further discussions with the FDA. Pharmacyclics will provide regulatory updates as further information on implementing the requirements with respect to Breakthrough Therapies are developed by the Secretary of Health and Human Services.

"This is a historic moment in oncology. We are truly honored to have received this Breakthrough Designation and are pleased for patients and clinicians with the FDA's decision to expedite the development of ibrutinib,
'/>"/>

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:10/17/2014)... October 17, 2014 ... has announced the addition of the  "China ... their offering.       (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ... in China impacted ... in consumption concept, dietary habit, way of ...
(Date:10/17/2014)... 17, 2014 Investor-Edge has initiated ... ARNA ), NPS Pharmaceuticals Inc. (NASDAQ: ... ), Momenta Pharmaceuticals Inc. (NASDAQ: MNTA ), ... on these five companies can be accessed at: ... October 16, 2014, ended on a mixed note as ...
(Date:10/17/2014)... BALTIMORE , Oct. 17, 2014  Ameritox SM ... announced the appointment of Thomas Smith , M.D., ... lead a field-based team offering scientific resources for healthcare ... Smith has held leadership positions at a variety of ... will benefit both the pain and behavioral health sides ...
Breaking Medicine Technology:China Interventional Cardiovascular Device Industry Report 2014-2017 2China Interventional Cardiovascular Device Industry Report 2014-2017 3Biotech Equities Technical Briefing - Arena Pharma, NPS Pharma, XOMA, Momenta Pharma, and Catalyst Pharma Partners 2Biotech Equities Technical Briefing - Arena Pharma, NPS Pharma, XOMA, Momenta Pharma, and Catalyst Pharma Partners 3Biotech Equities Technical Briefing - Arena Pharma, NPS Pharma, XOMA, Momenta Pharma, and Catalyst Pharma Partners 4Biotech Equities Technical Briefing - Arena Pharma, NPS Pharma, XOMA, Momenta Pharma, and Catalyst Pharma Partners 5Ameritox Appoints New Chief Medical Officer 2
... Pharmaceuticals, Inc. announced the appointment of Dave Lemus as ... 2011.  Lemus will join the leadership team at Sigma-Tau ... For the past 13 years, Lemus served as chief ... Segment; TecDAX), one of the Europe,s leading biotechnology companies ...
... Pharmaceuticals, Inc. (NASDAQ: AVNR ) today announced ... indicates that an Abbreviated New Drug Application (ANDA) for ... sulfate) capsules was submitted on March 7, 2011. The ... 2011. Avanir intends to vigorously enforce its ...
Cached Medicine Technology:Sigma-Tau Pharmaceuticals, Inc. Announces Addition of VP of Finance 2Avanir Pharmaceuticals Announces Paragraph IV ANDA Filing for NUEDEXTA 2Avanir Pharmaceuticals Announces Paragraph IV ANDA Filing for NUEDEXTA 3Avanir Pharmaceuticals Announces Paragraph IV ANDA Filing for NUEDEXTA 4
(Date:10/20/2014)... Women’s health specialist, Dr. Amber Murphy, MD, Ob/Gyn ... Inc., A Division of MaternOhio Clinical Associates, Inc., who ... patients annually. Dr. Murphy will provide a full range ... women’s life. She is accepting new patients at two ... , Dr. Murphy offers a wide variety of services ...
(Date:10/20/2014)... 2014 JZ Fitness, an independently operated ... wellness programming, authorship, international lecturing and community wellness, created ... the release of the JZ Fitness nutrition app, available ... coaching thousands of individuals on nutrition, Jenn Zerling (“JZ”) ... not require calorie counting or cumbersome food logging. ...
(Date:10/20/2014)... PA (PRWEB) October 20, 2014 ... Matthew Voicheck as Assistant Director of their ... role in managing the innovative turnkey drug sourcing, ... , Matthew brings over 12 years of industry ... joins Myoderm at the peak of their international ...
(Date:10/20/2014)... 20, 2014 National Teen Driver Safety Week ... American Academy of Pediatrics (Ohio AAP, http://www.ohioaap.org ) is ... parents of teen drivers to talk to their teens and ... Motor vehicle crashes are the leading cause of death for ... in fatal crashes, and 859 (42%) of those teen drivers ...
(Date:10/20/2014)... New York, NY (PRWEB) October 20, 2014 ... to be introduced in the U.S., has a lot to ... time when our country recognizes the achievements and contributions of ... marks the anniversary for Punzoné, and today it shares its ... and take a trip to Italy - even if it ...
Breaking Medicine News(10 mins):Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 2Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 3Health News:JZ Fitness Nutrition App Launches on iTunes 2Health News:JZ Fitness Nutrition App Launches on iTunes 3Health News:Myoderm Hires Matthew Voicheck to Lead Turnkey Drug Sourcing Service 2Health News:Ohio AAP Promotes National Teen Driver Safety Week 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 3Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 4
... rate since 1999, WASHINGTON, Sept. 11 ... eight years, marking the fourth,consecutive year premium increases ... Published by the Kaiser Family Foundation and ... 2007 Annual Survey found,that health insurance premiums increased ...
... Sept. 11 GlaxoSmithKline (NYSE:,GSK) believes that conclusions ... Nissen et. al. and Furberg et. al. in ... not confirm a difference in the,safety profile of ... that are common to all meta-analyses, by,the authors, ...
... Local Business Community Comes Together in Support of Event, ... still available for the fourth annual Detroit Uncorked, one ... Center, is held at Ford Field, Sept. 28 from ... Motor Company and Ford Field and created and,organized by ...
... Pennsylvania with substantial experience in infection control ... The Pennsylvania,Patient Safety Authority,s Board of Directors ... to help implement Act 52 of 2007. The,act ... in July to help reduce and,eliminate healthcare-associated infections ...
... Journal of the America Heart Association confirms that when young ... influence their heart disease risk later in life. ... have landmark implications on how children should be taught to ... reduction in intake of saturated fat, was found to be ...
... 11 (HealthDay News) -- Carvedilol, a newer member of the beta ... failure, did not help children with the condition, a new study ... it -- was almost exactly the same for 103 young heart-failure ... got a placebo. , "Heart failure in children is both not ...
Cached Medicine News:Health News:Health Insurance Premium Growth Slows for Fourth Straight Year 2Health News:GlaxoSmithKline Responds to JAMA Articles 2Health News:GlaxoSmithKline Responds to JAMA Articles 3Health News:GlaxoSmithKline Responds to JAMA Articles 4Health News:GlaxoSmithKline Responds to JAMA Articles 5Health News:Tickets Still Available for Detroit Uncorked; 2Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 2Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 3Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 4Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 5Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 6Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 7Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 8Health News:Patient Safety Authority Board of Directors Names Infection Advisory Panel 9Health News:Children who learn heart healthy eating habits lower heart disease risk 2Health News:Children who learn heart healthy eating habits lower heart disease risk 3Health News:Beta Blocker Doesn't Help Children With Heart Failure 2
The PICO50 is used for arterial line sampling....
The safePICO is a prebarcoded arterial sampler that helps you ensure patient and caregiver safety. SafePICO is part of 1st automatic, the worlds first automatic blood gas analysis system....
Non-invasive and continuous tcpCO2 and tcpO2 patient monitoring....
The TCM400 is the first and only portable instrument to provide up to six simultaneous measurements of transcutaneous oxygen tension (tcpO2)...
Medicine Products: