Navigation Links
New Drug Application for Ibrutinib Submitted to the U.S. FDA
Date:7/10/2013

SUNNYVALE, Calif., July 10, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The submission was based on data from Phase II studies in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL. With this submission, Pharmacyclics is also requesting Priority Review. Pharmacyclics is jointly developing ibrutinib with Janssen.

The NDA submission follows the receipt of a Breakthrough Therapy Designation from the FDA in February 2013 for ibrutinib as a monotherapy for the treatment of patients with relapsed/refractory MCL, and receipt of a second Breakthrough Therapy Designation for the treatment of patients with CLL/SLL with deletion of the short arm of chromosome 17 (del 17p). Further information on the implications of this filing for potential commercialization will be provided subsequent to the FDA rendering a decision on the filing.

"We are very excited having achieved this major milestone. This first NDA for ibrutinib was made possible in record time because of the continuous support and consultations we received from the FDA," said Dr. Urte Gayko, Senior Vice President of Global Regulatory Affairs, Pharmacyclics. "We look forward to continuing to work with the FDA as they review the application for ibrutinib through the new Breakthrough Therapy Designation process."

"These past months have been enormously active and productive for Pharmacyclics and our ibrutinib partner, Janssen. We received our first of three Breakthroug
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine technology :

1. Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro™ for Treatment of Chronic Pain
2. Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
3. Bio-AMD, Inc.; Patent Application for Cartridge Test Cap
4. Global Ablation Technologies Market (2011-2016) - By Application and Devices in Radiofrequency, Cryoablation, Microwave, Ultrasound, Hydrothermal, Radiation, Electrical, Light/Laser and Hydromechanical - Global Trends & Competitive Analysis
5. Rubicon Genomics Launches ThruPLEX™ Family of Sample Preparation Products for Next Generation Sequencing Applications
6. Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor
7. CSL Behring Announces FDA Filing of Biologics License Application for 4-Factor PCC for Urgent Reversal of Vitamin K Antagonist Anticoagulant Therapy
8. Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin to Treat Patients with Type 2 Diabetes
9. Philips demonstrates innovations in nuclear medicine imaging with a comprehensive portfolio of NM applications for IntelliSpace Portal
10. Clinical Safety Data for ChromaDex®s Patented pTeroPure® (pterostilbene) Released at 6th World Congress on Polyphenols Applications in Paris
11. UltraTape announces Cleanroom Labels for Cryogenic Laboratory applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... SHANGHAI , Oct. 22, 2014 /PRNewswire/ ... FMI ) and WuXi PharmaTech (Cayman) Inc. (NYSE: ... Foundation Medicine,s comprehensive genomic profiling to biopharmaceutical companies conducting ... Under the terms of the collaboration, Foundation ... laboratory component of Foundation Medicine,s FoundationOne® assay at the ...
(Date:10/20/2014)... , 20 de octubre de 2014 /PRNewswire/ ... el campo de la pulmonología intervencional, anunció hoy ... RENEW, casi 3 meses antes de lo programado. El ... exención de dispositivo de investigación (IDE) aprobada por ... el sistema de espiral de reducción de volumen ...
(Date:10/20/2014)... 20, 2014  Luoxis Diagnostics, Inc., a subsidiary ... announced that its academic collaborators will present several ... for its novel RedoxSYS Diagnostic System, a first-in-class ... body in response to injury or illness.  A ... a clinical marker will be presented by ...
Breaking Medicine Technology:Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 2Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 3Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 4Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 5PneumRx concluye inscripción en prueba fundamental RENEW 2PneumRx concluye inscripción en prueba fundamental RENEW 3Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 2Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 3Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 4Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 5
... 30, 2011 Roche announced today the opening of ... campus in Nutley, N.J. The Roche Center of Excellence ... safety studies, and Phase 1 and 2 clinical studies. ... process potent compounds into medicines for clinical trials. ...
... 30, 2011 ViroPharma Incorporated (NASDAQ: VPHM ... Intellect Neurosciences, Inc. (OTCBB: ILNS) to its clinical stage ... Friedreich,s Ataxia (FA), a rare, hereditary, progressive neurodegenerative disease. ... a naturally occurring, small molecule that has potent anti-oxidant ...
Cached Medicine Technology:Roche Opens New Center of Excellence Facility 2ViroPharma Licenses Rights From Intellect Neurosciences for Product Candidate for Friedreich's Ataxia 2ViroPharma Licenses Rights From Intellect Neurosciences for Product Candidate for Friedreich's Ataxia 3ViroPharma Licenses Rights From Intellect Neurosciences for Product Candidate for Friedreich's Ataxia 4
(Date:10/22/2014)... 2014 The Louis W. ... dedicated to distribute health information technology innovation to ... announced the development of six key guiding principles ... receiving healthcare. These are an expansion of the ... care that is respectful of and responsive to ...
(Date:10/22/2014)... 2014 During the Western United States’ ... runs dangerously low, Southern Oregon’s water is proving resistant ... the lowest mountain snow pack on record in 2014, ... early autumn.* That was the observation of journalist-hikers Art ... “Hiking Southern Oregon,” during an interview with water advocate ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 Losing Weight Your ... industry is staring you in the face, it certainly can ... not do your body an extra favor by doing it ... tempting crash diets. Instead, listen to your body, exercise regularly, ... Exercise is essential to losing weight; you need to exercise ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 Richard Carlson, ... an industry leader with over 25 years experience. ... leader in the areas related to EDI, B2B Commerce, ... is an Editorial Advisory Board member for Pharmaceutical Commerce ... Blue Fin Group is a management and technology ...
(Date:10/22/2014)... By Maureen Salamon ... -- Black women undergoing in vitro fertilization (IVF) are only ... using the popular assisted reproduction technique, new research indicates, and ... In the study, about 31 percent of white patients ... black patients. Analyzing more than 4,000 IVF cycles over ...
Breaking Medicine News(10 mins):Health News:The Sullivan Institute for Healthcare Innovation Announces Release of Guiding Principles for Patient Experience-Centered Care 2Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 2Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 3Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 4Health News:ReductionGuruMD Presents Ways to Improve Your Weight Loss Results 2Health News:Rich Carlson and Marc Duey to Hold Workshop at CBI’s Specialty Pharmacy and Distribution Networks Conference 2Health News:Black Women Fare Worse With Fertility Treatments, Study Says 2Health News:Black Women Fare Worse With Fertility Treatments, Study Says 3
... behavior therapy (CBT) in overcoming depression can be assessed ... of Pittsburgh School of Medicine. In a study published ... Psychiatry, the official journal of the American Psychiatric Association, ... to therapy could be a valuable tool for doctors. ...
... with the way the head of the North Coast Area Health ... that he has denied telling the Coraki community about the plans ... staged a protest against the head of the North Coast Area ... mushrooms and wanted answers about the Health Department's plans for the ...
... April's Nutrition Reviews reveals that people on vegetarian diets ... be slimmer// than meat-eaters, and they experience lower rates ... life-threatening conditions linked to overweight and obesity. ... shows the weight-loss effect does not depend on exercise ...
... health benefits associated with moderate drinking has been challenged ... drinking may not offer protection// against cardiovascular disease. ... up to two drinks per day can help reduce ... that it lowers the risk of contracting some type ...
... blamed Britain's bird flu contingency plans as being too ... experiences// with dealing similar pandemics. However, the plans are ... the Hillingdon Primary Care Trust in Middlesex, southern England. ... They are asking us to plan for the middle ...
... suffice to prevent about two-thirds of all skin cancers//. ... in skin cancer. While anyone can develop skin cancer, the ... easily, researchers said. ,About 10 percent of ... had the disease, but everyone should be on the lookout ...
Cached Medicine News:Health News:Brian Imaging Can Foretell Results Of Treating Depression 2Health News:Moderate Drinking Does Not Guard Against Heart Disease 2Health News:Britain's Bird Flu Contingency Plans Faces Criticism 2
Econo lucae bayonet forceps....
Medpor 2/3 Orbit implants are designed to replace non load bearing bony structures in the orbital area....
... The Medpor Inferior Orbital Rim implant ... projection and is designed to be trimmed ... patient. A small flange allows it to ... the orbital floor. This flange allows easier ...
Flattened points in vertical plane, straight shafts, cross action, round handle....
Medicine Products: