Navigation Links
Boehringer Ingelheim's investigational volasertib receives FDA Breakthrough Therapy designation
Date:9/17/2013

RIDGEFIELD, Conn., Sept. 17, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced the FDA has granted Breakthrough Therapy designation to volasertib*, an investigational inhibitor of polo-like kinase (Plk), being evaluated for the treatment of patients aged 65 or older with previously untreated acute myeloid leukemia (AML), ineligible for intensive remission induction therapy.

"This FDA Breakthrough Therapy designation provides Boehringer Ingelheim the opportunity to engage in an ongoing dialogue with the FDA  to help expedite the development of volasertib as a potential treatment option for these patients with AML," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, U.S. Regional Medical Director, Boehringer Ingelheim Pharmaceuticals, Inc. "Volasertib is one of many investigational compounds in Boehringer Ingelheim's growing oncology pipeline and is an example of our commitment to exploring treatment approaches with the goal of improving patient outcomes."

The Breakthrough Therapy designation process was established by the FDA in July 2012 and is intended to facilitate and expedite the development and review of drugs for serious or life-threatening conditions if  preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

AML is an aggressive cancer of the bone marrow and blood.2 It accounts for 25 percent of all adult leukemias in the Western world3 and has one of the lowest survival rates of all leukemias.3 In 2013, it is estimated there will be 14,590 new cases of AML diagnosed in the U.S. and 10,370 deaths from the disease.4

AML is primarily a disease of later adulthood; the average age of an AML patient is 65 years.5 A common treatment approach for AML
'/>"/>

SOURCE Boehringer Ingelheim
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Boehringer Ingelheim Expands Investigation of Interferon-free Hepatitis C Treatment Regimens to Reach More Patient Types through Presidio Pharmaceuticals Clinical Collaboration
2. Boehringer Ingelheim Pharmaceuticals, Inc. Statement on RE-ALIGN Data
3. Boehringer Ingelheim Announces Agreement to Study Real-World Use of Oral Anticoagulants
4. Boehringer Ingelheim Renews and Expands License to NextBio Research Platform
5. Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company Statement on the ADA Request for Independent Review of Incretin-Based Therapies
6. Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference
7. Boehringer Ingelheim Presents Progression-Free Survival Data for Investigational Afatinib and Nintedanib in Advanced NSCLC
8. ASCO 2013: Boehringer Ingelheim to Present Data Across Multiple Cancers, Including Different Treatment Settings for Advanced NSCLC
9. Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company launch educational campaign about emerging science in type 2 diabetes
10. Boehringer Ingelheim to Announce Pivotal Phase 3 Hepatitis C Data at the International Liver Congress
11. European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Companys empagliflozin*, an investigational type 2 diabetes treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... 30, 2014 Stryker brand ambassadors Fred Funk ... 3M Championship Champions Tour event near Minneapolis, MN ... Blaine . Stryker is the official joint replacement products company ... Friday, August 1 st through Sunday, August 3 rd , ... on-site joint health destination located in the Pioneer Press Expo tent ...
(Date:7/30/2014)... -- DigiPath, Inc. (OTCBB and OTCQB: DIGP), a digital pathology ... and education markets, announced today that has been no ... disclosed or, to its knowledge, any other reason to ... "We have noticed unusual price and volume increases for ... Steve Barbee , CEO of DigiPath. "While we ...
(Date:7/30/2014)... July 30, 2014 /PRNewswire-iReach/ -- This is a ... Chinese Heparin sodium (CAS 9041-08-1) & calcium (CAS ... information of Heparin sodium (CAS 9041-08-1) & calcium ... technology. The report then explores global and China,s ... calcium (CAS 37270-89-6) listing their product specification, capacity, ...
Breaking Medicine Technology:Stryker Brand Ambassadors Fred Funk And Hal Sutton Set To Play At 3M Championship 2Stryker Brand Ambassadors Fred Funk And Hal Sutton Set To Play At 3M Championship 3Stryker Brand Ambassadors Fred Funk And Hal Sutton Set To Play At 3M Championship 4Stryker Brand Ambassadors Fred Funk And Hal Sutton Set To Play At 3M Championship 5DigiPath No New Corporate Developments 2Heparin Sodium & Calcium Industry for Global and Chinese Markets Forecast to 2019 2Heparin Sodium & Calcium Industry for Global and Chinese Markets Forecast to 2019 3Heparin Sodium & Calcium Industry for Global and Chinese Markets Forecast to 2019 4Heparin Sodium & Calcium Industry for Global and Chinese Markets Forecast to 2019 5
... pirfenidone may provide meaningful clinical benefit in IPF patients ... reported -- Conference Call and Webcast at 9 p.m. ... InterMune, Inc. (Nasdaq: ITMN ) reported ... evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) ...
... 19 New data demonstrate that maintenance therapy with ... time to relapse compared to placebo in patients with ... this week at a major medical meeting. Bipolar ... in a person,s mood, energy and ability to function. ...
Cached Medicine Technology:Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 2Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 3Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 4Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 5Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 6Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 7Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 8Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 9Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 10Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 11Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 12RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder 2RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder 3RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder 4RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder 5RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder 6RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder 7RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder 8RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder 9RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder 10
(Date:7/30/2014)... (PRWEB) July 30, 2014 Conducting ... Advanced Critical Thinking Skills and Innovative Techniques to ... Immel Resources and FDAnews**, Sept. 17-18, 2014 – ... been the #1 reason for 483 observations since ... clear: Developing a successful CAPA program has never ...
(Date:7/30/2014)... Good Neighbor Community Services announced ... episode of Innovations with Ed Begley Jr, airing ... show times TBA. , In this segment, viewers ... vision to redefine the traditional approach to serving ... Through passion, innovation, determination, excellence, and collaboration, Good ...
(Date:7/30/2014)... CA (PRWEB) July 30, 2014 SF ... accessories at the lowest prices on the internet with ... Cables in two lengths and two colors. These lightning ... standards. , The high quality SF Cable ... connector with digital signal delivering faster charging and syncing. ...
(Date:7/30/2014)... July 30, 2014 Hamilton Facial ... of its new Carmel office on July 30th. After ... finally be moving to the state-of-the-art suite, located only ... innovative space will allow for one-on-one patient comfort, shorter ... experience. , Dr. Hamilton’s new office-suite will continue ...
(Date:7/30/2014)... ... ... ... , ... , For the study, published this week in the peer-reviewed journal Quality of Life Research , a UCLA team led by ...
Breaking Medicine News(10 mins):Health News:FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC 2Health News:FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC 3Health News:FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC 4Health News:Good Neighbor Community Services to be Featured in an Upcoming Episode of Innovations With Ed Begley, Jr. 2Health News:SF Cable Delivers Certified Lightning Cable in Multiple Sizes and Colors 2Health News:Hamilton Facial Plastic Surgery Opens New Carmel Office 2Health News:Diverticulitis patients reveal psychological, physical symptoms long after acute attacks 2Health News:Diverticulitis patients reveal psychological, physical symptoms long after acute attacks 3
... OSLO, June 24 DiaGenic ASA (OSL: ... with Merz Pharmaceuticals,GmbH, an innovative developer of drugs for ... to biomarkers for Mild Cognitive,Impairment (MCI), increasingly considered a ... be used to identify patients with MCI,prone to converting ...
... ... most individuals know the importance of applying sunscreen regularly, but in a recent literature study ... be even more at risk for developing the deadly disease. , ... Rosemont, IL (Vocus) June 24, 2009 -- With ...
... ... prevention for at-risk horses. , ... Shenandoah, IA (PRWEB) June 24, 2009 -- Equine obesity is on the rise in the ... at a higher risk for laminitis: a debilitating condition responsible for thousands of deaths each ...
... ... sample and learn about their new products at the ASMBS conference. The Company located in ... ... Advantage, a Division of Catalina Lifesciences, could barely keep up with demand to sample and ...
... Cytox Limited, a UK-based neuroscience company that provides ... disease (AD) clinical trials, has announced completion of a ... million). , , Proceeds will be used ... AD and mild cognitive impairment (MCI). Cytox,s biomarkers help ...
... at greater risk of heart-rhythm abnormality: study , TUESDAY, ... severe sleep-related breathing problems are at increased risk for ... study included 2,911 men who underwent sleep testing between ... paused or shallow breathing during sleep were more likely ...
Cached Medicine News:Health News:DiaGenic to Provide MCI Biomarkers for Merz Pharmaceuticals 2Health News:DiaGenic to Provide MCI Biomarkers for Merz Pharmaceuticals 3Health News:Study Finds Skin Cancer Rates Higher Among Athletes 2Health News:Equine Obesity is Associated with Significant Health Issues, Including Insulin Resistance and Laminitis 2Health News:Interest in the Bariatric Advantage Chewy Bites and Other New Products is at an All-Time High at the ASMBS Conference 2Health News:Cytox Raises Pre-Series A Financing From Management and Existing UK Investors, Welcomes First US Investors 2Health News:Cytox Raises Pre-Series A Financing From Management and Existing UK Investors, Welcomes First US Investors 3Health News:Cytox Raises Pre-Series A Financing From Management and Existing UK Investors, Welcomes First US Investors 4Health News:Sleep Disorders Linked to Arrhythmias 2
Indications For Usage: ,Single patient use on anesthetized patients and respiratory care patients who require a breathing circuit. The product is intended to be replaced at least once every 24 hours...
... The Portex® Thermovent® T helps provide protection ... It is small and extremely lightweight making it ... adults. With a high rate of heat and ... secretion retention., ,All HMEs and filters have ...
... Thermovent® T helps provide protection to the exposed ... and extremely lightweight making it ideal for active ... high rate of heat and moisture recovery, it ... ,All HMEs and filters have ISO standard tapered ...
... Thermovent® T helps provide protection to the exposed ... and extremely lightweight making it ideal for active ... high rate of heat and moisture recovery, it ... ,All HMEs and filters have ISO standard tapered ...
Medicine Products: