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:8/28/2014)... 2014  STAAR Surgical Company (NASDAQ: STAA ) ... delivery systems for the eye, today announced that management will ... New York Palace Hotel on Wednesday, September 3 at 7:15 ... President and CEO will offer a general overview of the ... be joined by Steve Brown , CFO, and ...
(Date:8/28/2014)... , Aug. 28, 2014 Synthetic Biologics, ... anti-infective biologic and drug candidates targeting specific pathogens ... Diosynth Biotechnologies UK Limited (Fujifilm), announced today confirmation ... cGMP manufacturing of SYN-004, Synthetic Biologics, proprietary oral ... difficile ( C. difficile ) infections. ...
(Date:8/28/2014)... -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL ... trials evaluating the use of collagenase clostridium histolyticum (CCH) for ... with a palpable cord will be presented at the upcoming ... Surgery of the Hand (ASSH) being held in ... (CCH) is a biologic approved in the U.S., EU, ...
Breaking Medicine Technology:STAAR Surgical To Present At The Baird 2014 Health Care Conference 2Synthetic Biologics and FUJIFILM Diosynth Biotechnologies UK Announce Significant Improvement in API Manufacturing of SYN-004 for the Prevention of C. difficile 2Synthetic Biologics and FUJIFILM Diosynth Biotechnologies UK Announce Significant Improvement in API Manufacturing of SYN-004 for the Prevention of C. difficile 3Synthetic Biologics and FUJIFILM Diosynth Biotechnologies UK Announce Significant Improvement in API Manufacturing of SYN-004 for the Prevention of C. difficile 4Synthetic Biologics and FUJIFILM Diosynth Biotechnologies UK Announce Significant Improvement in API Manufacturing of SYN-004 for the Prevention of C. difficile 5Auxilium Pharmaceuticals, Inc. To Present CCH Data For Concurrent Treatment Of Multiple Dupuytren's Cords At ASSH Annual Meeting 2Auxilium Pharmaceuticals, Inc. To Present CCH Data For Concurrent Treatment Of Multiple Dupuytren's Cords At ASSH Annual Meeting 3Auxilium Pharmaceuticals, Inc. To Present CCH Data For Concurrent Treatment Of Multiple Dupuytren's Cords At ASSH Annual Meeting 4Auxilium Pharmaceuticals, Inc. To Present CCH Data For Concurrent Treatment Of Multiple Dupuytren's Cords At ASSH Annual Meeting 5Auxilium Pharmaceuticals, Inc. To Present CCH Data For Concurrent Treatment Of Multiple Dupuytren's Cords At ASSH Annual Meeting 6
... Medical Systems Ltd. (NASDAQ: DHRM) ("Dehaier" or ... assembly, marketing and sale of medical devices and ... plans to release its financial results for the ... 31, 2011 on Monday, March 19, 2012, after the stock ...
... Timothy C. Tyson, Aptuit Chairman, announced that effective immediately, ... Operating Officer of Aptuit LLC. Following the recent sale ... has been promoted from his previous position at Aptuit ... Needleman is responsible for all day-to-day operations of the ...
Cached Medicine Technology:Dehaier Medical Systems Schedules 2011 Fourth Quarter and Full Year Financial Results and Conference Call 2Dehaier Medical Systems Schedules 2011 Fourth Quarter and Full Year Financial Results and Conference Call 3Aptuit LLC Names Stuart E. Needleman as President and Chief Operating Officer 2
(Date:8/28/2014)... (PRWEB) August 28, 2014 Edvance360 ... the top ten tools for online teaching, as well ... for Best Course or Learning Management System, announced that ... Academy, Typewell, Dialysis Treatment Center of America, Metis Leadership ... and HMG Plus, to the user community. , ...
(Date:8/28/2014)... 2014 Every year, cataracts affect over 22 ... the leading cause of blindness in the world. Characterized by ... the iris, cataracts are estimated to affect an additional 30 ... aging population. Cataracts are just one of the many conditions ... Tracy of Carlsbad Eye Care screens patients for a number ...
(Date:8/28/2014)... (PRWEB) August 28, 2014 Labor Day ... the beach and those last glorious glimpses of summer. ... patients are planning on spending their long weekend recovering ... Sadati, a board certified facial plastic and reconstructive surgeon ... patients have taken advantage of their holiday weekends to ...
(Date:8/28/2014)... (PRWEB) August 28, 2014 Atlantic Information ... of the latest addition to its Management Insight Series, ... a Major Patient Privacy/Security Risk . The new report ... manage the risks associated with portable electronic devices, and ... federal requirements. , With expert advice on how to ...
(Date:8/28/2014)... 2014 In the healthcare industry, there ... struggle with: How can the overall quality of patient ... of the healthcare industry tackles this question, and has ... job satisfaction and the quality of patient care. ... in “ Organizational Factors related to Improving Quality of ...
Breaking Medicine News(10 mins):Health News:Edvance360 Continues to Experience Growth in Corporate, K-12, Health, and Non-Profit Sectors 2Health News:Cataract Awareness Month an Opportunity to Focus on Vision Care and Ocular Health 2Health News:Newport Beach Facial Plastic Surgeon, Dr. Kevin Sadati Announces a Patient Trend of Scheduling Cosmetic Surgery Procedures over Long Holiday Weekends 2Health News:Newport Beach Facial Plastic Surgeon, Dr. Kevin Sadati Announces a Patient Trend of Scheduling Cosmetic Surgery Procedures over Long Holiday Weekends 3Health News:Newport Beach Facial Plastic Surgeon, Dr. Kevin Sadati Announces a Patient Trend of Scheduling Cosmetic Surgery Procedures over Long Holiday Weekends 4Health News:New Report Offers Best Practices for Avoiding the Patient Privacy/Security Risks Posed by Mobile Devices 2Health News:New Healthcare Study Explores Strategies for Improving Patient Care 2Health News:New Healthcare Study Explores Strategies for Improving Patient Care 3Health News:New Healthcare Study Explores Strategies for Improving Patient Care 4
... July 7 HealthSouth,Corporation (NYSE: HLS ) ... to acquire a 30-bed inpatient rehabilitation unit at ... is currently owned by Columbia,Medical Center of Arlington ... operations will relocate to HealthSouth Rehabilitation,Hospital of Arlington., ...
... recycling benefits our planet; and now new research suggests ... cancer. Scientists at Stanford University have identified a molecule ... cells. The research, published by Cell Press in the ... , may drive treatment strategies for cancer in an ...
... and geographic boundaries are some of the challenges that ... for a possible influenza pandemic, according to a new ... who are leading planning efforts for an influenza outbreak ... defined by political lines," said George Avery, an assistant ...
... Pa., July 7 Digestive Care, Inc. (DCI),announced today ... New Drug,Application ("NDA") for PANCRECARB(R) (pancrelipase), used in the ... and Drug,Administration ("FDA"). The FDA has granted the product ... used to treat EPI for over,a decade and we ...
... Satisfaction Rate 94% - 100%, ARLINGTON HEIGHTS, ... after an elective mastectomy are satisfied with,their decision, ... do it,again, reports a study in July,s Plastic ... American Society of Plastic Surgeons,(ASPS). In addition, breast ...
... Ill. Women who have breast reconstruction after an ... complication rates and 98 percent would do it again, ... Surgery , the official medical journal of the American ... reconstruction after preventive mastectomy was as safe as or ...
Cached Medicine News:Health News:HealthSouth To Acquire Rehabilitation Unit at Medical Center of Arlington 2Health News:HealthSouth To Acquire Rehabilitation Unit at Medical Center of Arlington 3Health News:Can recycling be used to treat cancer? 2Health News:Political borders, health-care issues complicate pandemic planning 2Health News:Political borders, health-care issues complicate pandemic planning 3Health News:Digestive Care, Inc. Announces the Filing of the First Module of NDA Submission for PANCRECARB(R) (pancrelipase) 2Health News:98% of Elective Mastectomy Patients Would Have Reconstruction Again, Says ASPS Study 2Health News:98 percent of elective mastectomy patients would have reconstruction again, says ASPS study 2
... is ideal for all liquid handling applications ... operating buttons, and various dispensing techniques such ... make this a lab favorite. It intuitively ... pipette without any adverse effects on the ...
Single channel module for Finnpipette Biocontrol - Universal handle sold separately...
... the ease and comfort you've come to expect ... in clinical trials agreed that the BD Lancet ... settings allow you to choose the best lancet ... lancets, the device also helps eliminate the "vibrations" ...
... StaRRsed-III is a system that measures ... samples. This rate may be relevant ... The sedimentation rate is measured in ... typically used in high-volume settings such ...
Medicine Products: