Dyspnea News and Research

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Dyspnea or dyspnoea or shortness of breath is a debilitating symptom that is the experience of unpleasant or uncomfortable respiratory sensations.

Allos Therapeutics to present FOLOTYN trial results at ESMO Congress

Allos Therapeutics, Inc. today announced that results from the Phase 2b investigational trial of FOLOTYN (pralatrexate injection) versus erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC) will be presented at the 35th European Society of Medical Oncology (ESMO) Congress

10 Sep 2010

Positive results from YM BioSciences' CYT997 Phase I study for vascular disruption in tumors

YM BioSciences Inc., today announced the publication of Phase I results demonstrating that CYT997, a novel vascular disrupting agent (VDA), was well tolerated at doses that were associated with pharmacodynamic evidence of vascular disruption in tumors. The article entitled "Phase I trial of CYT997, a novel cytotoxic and vascular-disrupting agent," was published in the premier cancer journal, the British Journal of Cancer.

8 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Genzyme Corporation announced today that the two-year follow-up results from the phase 2 clinical trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood. The results have been pre-published on the journal's website and are available to subscribers.

23 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

Sucampo Pharmaceuticals second-quarter 2010 total revenue declines to $13.8 million

Sucampo Pharmaceuticals, Inc. today reported its consolidated financial results for the quarter and six months ended June 30, 2010.

7 Aug 2010

Sanofi-aventis receives FDA approval for new Taxotere Injection Concentrate formulation

Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved a new one-vial formulation of its chemotherapeutic agent Taxotere® (docetaxel) Injection Concentrate. The 1-vial Taxotere is anticipated to become available to cancer treatment clinics and hospitals nationwide in the fall in both 80 mg and 20 mg dosages.

5 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Study shows prevalence, severity of dyspnea in long-term lung cancer survivors

With the growing number of long-term lung cancer survivors, research is needed to identify and address cancer survivorship issues. One of the most common and debilitating symptoms among lung cancer patients is dyspnea, or shortness of breath. As most studies of dyspnea have reviewed patients with active lung cancer or immediately after treatment, the prevalence of dyspnea over the long-term once treatment has been completed is not well characterized.

3 Aug 2010

Xeomin receives FDA approval for treatment of cervical dystonia

Merz Pharmaceuticals today announced that the United States Food and Drug Administration has approved Xeomin (incobotulinumtoxinA), a botulinum toxin type A for the treatment of adults with cervical dystonia or blepharospasm. According to an epidemiology study conducted in Rochester, Minnesota, the prevalence of focal dystonia, which includes cervical dystonia and blepharospasm, is estimated at 295 per million people in the U.S.

2 Aug 2010

$Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released$

Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released

Millennium: The Takeda Oncology Company today reported new correlative science data from the pivotal PINNACLE trial of VELCADE (bortezomib) in patients with relapsed/refractory mantle cell lymphoma. The data, derived from an analysis of archived tumor samples, tested pre-specified biomarkers for their association with time to progression and response to treatment with VELCADE in patients with relapsed MCL.

30 Jul 2010

Pivotal Phase 3 IMPACT study results of PROVENGE published in New England Journal of Medicine

Dendreon Corporation announced today the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE (sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer. The manuscript is published in the July 29, 2010 issue of the journal.

29 Jul 2010

Allos reports topline results from Phase 2b trial of FOLOTYN vs erlotinib in advanced NSCLC

Allos Therapeutics, Inc. today announced topline results from the Company's randomized Phase 2b investigational trial of FOLOTYN® (pralatrexate injection) versus erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC) who had received one or two prior systemic treatments including at least one prior platinum-based regimen. The objective of the trial was to estimate the efficacy of FOLOTYN compared to that of erlotinib as assessed by overall survival.

28 Jul 2010

Allos reports net loss of $20.0 million for second-quarter 2010

Allos Therapeutics, Inc. today reported its financial results and business highlights for the quarter and six months ended June 30, 2010.

28 Jul 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

Research Roundup: 'Pay-for-performance' unintended effects; Lessons from Mass.; End of life treatment

Archives of Internal Medicine: The Quality Of Care Provided To Hospitalized Patients At The End of Life - In this study, researchers used a set of quality indicators to assess the end-of-life care and pain management received by 496 patients who died three or more days after admission at the University of California-Los Angeles Medical Center. The authors found "pain assessments (94%) and treatments for pain (95%) and dyspnea [breathing problems] (87%) were performed with fidelity."

3 Jul 2010

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Novartis Pharmaceuticals Corporation announced today that results of a Phase III study show Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival, or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET). The study, RADIANT-3, was presented at the 12th World Congress on Gastrointestinal Cancer and is part of the largest clinical trial program in patients with advanced NET.

1 Jul 2010

Clinical assessment study identifies opportunities to improve end-of-life care

Even at a hospital recognized for managing seriously ill patients, a systematic assessment of clinical measures associated with end-of-life care identified opportunities to improve treatment for those dying in the hospital, according to a report in the June 28 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

29 Jun 2010

Dyspnea News and Research

Further Reading

Allos Therapeutics to present FOLOTYN trial results at ESMO Congress

Positive results from YM BioSciences' CYT997 Phase I study for vascular disruption in tumors

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Sucampo Pharmaceuticals second-quarter 2010 total revenue declines to $13.8 million

Sanofi-aventis receives FDA approval for new Taxotere Injection Concentrate formulation

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Study shows prevalence, severity of dyspnea in long-term lung cancer survivors

Xeomin receives FDA approval for treatment of cervical dystonia

Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released

Pivotal Phase 3 IMPACT study results of PROVENGE published in New England Journal of Medicine

Allos reports topline results from Phase 2b trial of FOLOTYN vs erlotinib in advanced NSCLC

Allos reports net loss of $20.0 million for second-quarter 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Research Roundup: 'Pay-for-performance' unintended effects; Lessons from Mass.; End of life treatment

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Clinical assessment study identifies opportunities to improve end-of-life care

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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