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.

Millennium submits two VELCADE sNDAs to FDA

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that it has submitted two supplemental new drug applications (sNDAs) for VELCADE® (bortezomib) for Injection to the U.S. Food and Drug Administration. The first application seeks to add a subcutaneous route of administration for VELCADE. The second application is for the use of VELCADE in combination with rituximab in patients with relapsed follicular non-Hodgkin lymphoma (NHL).

26 Apr 2011

AstraZeneca announces U.S. availability of vandetanib for rare medullary thyroid cancer

AstraZeneca today announced that the orphan drug vandetanib is now available to U.S. patients for the treatment of medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body.

25 Apr 2011

Baxter's ARTISS phase III study results in face lift surgery presented at AAPS meeting

Baxter International Inc. announced today the results of a phase III study evaluating the safety and efficacy of ARTISS in 75 patients.

From Baxter International Inc. 12 Apr 2011

AstraZeneca's vandetanib receives FDA approval in medullary thyroid cancer

AstraZeneca today announced that the U.S. Food and Drug Administration approved the orphan drug vandetanib for the treatment of medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body.

7 Apr 2011

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

Sanofi-aventis, Regeneron announce results of VEGF Trap Phase III trial in second-line NSCLC

Sanofi-aventis and Regeneron Pharmaceuticals, Inc. announced results from the Phase III VITAL trial evaluating the investigational agent aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC).

11 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

FDA approves change to prescribing information for Gilead Sciences' Letairis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved a change to the prescribing information for Letairis (ambrisentan 5 mg and 10 mg tablets), the company's once-daily treatment to improve exercise ability and delay clinical worsening in pulmonary arterial hypertension (PAH, WHO Group 1) patients with predominantly WHO Functional Class II-III symptoms.

5 Mar 2011

Allos reaches SPA agreement with FDA for FOLOTYN Phase 3 trial in PTCL

Allos Therapeutics, Inc. today announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the design of the Company's Phase 3 clinical trial of FOLOTYN® (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL).

4 Mar 2011

Decision Resources: 52% of surveyed cardiologists identify furosemide as efficacious acute heart failure therapy

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the highest proportion of surveyed cardiologists identify furosemide as the most efficacious agent for the treatment of acute heart failure when compared to other available therapies.

1 Mar 2011

The Lancet journal publishes XGEVA Phase 3 study results against prostate cancer, bone metastases

Amgen today announced the publication of results from a Phase 3 head-to-head trial that compared XGEVA to Zometa in preventing bone complications called skeletal-related events in 1,901 men with prostate cancer and bone metastases.

25 Feb 2011

Trevena commences TRV120027 Phase 2a trial in patients with acute heart failure

Trevena Inc., the leader in G-protein coupled receptor biased ligand drug discovery, today announced the initiation of a Phase 2a clinical trial with its lead program, TRV120027, a beta-arrestin biased angiotensin II type 1 receptor ligand, the first biased ligand designed to treat patients with acute heart failure.

23 Feb 2011

Amgen announces publication of XGEVA Phase 3 study results against solid tumors in Journal of Clinical Oncology

Amgen today announced the publication of results from a pivotal Phase 3 study of 1,776 advanced cancer patients with different types of solid tumors or multiple myeloma, which compared XGEVA to Zometa in preventing skeletal-related events.

23 Feb 2011

Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation today announced three-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate. Sustained or further improvements were observed across all endpoints, including bone disease, at the three-year timepoint.

19 Feb 2011

Positive interim data from cabozantinib Phase 2 metastatic castration-resistant prostate cancer trial

Exelixis, Inc. today reported updated interim data from the cohort of patients with metastatic castration-resistant prostate cancer (CRPC) treated with cabozantinib (XL184) in an ongoing phase 2 adaptive randomized discontinuation trial.

18 Feb 2011

Phase II results of VELCADE in patients with aggressive lymphoma published in Journal of Clinical Oncology

Millennium: The Takeda Oncology Company today announced that Phase II results of a clinical trial examining VELCADE (bortezomib) in patients with previously untreated aggressive lymphoma were published in the Journal of Clinical Oncology.

5 Feb 2011

Emergent BioSolutions initiates TRU-016 Phase Ib/II study for chronic lymphocytic leukemia

Emergent BioSolutions Inc. today announced the initiation of a Phase Ib/II study (16201) of TRU-016 for chronic lymphocytic leukemia (CLL). TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP™) protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott.

25 Jan 2011

FOLOTYN Phase 2 peripheral T-cell lymphoma study results published in Journal of Clinical Oncology

Allos Therapeutics, Inc. today announced that the Journal of Clinical Oncology has published data from the Company's pivotal Phase 2 PROPEL study demonstrating clinical activity of FOLOTYN® (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

20 Jan 2011

FibroGen initiates FG-3019 open-label phase 2 study in idiopathic pulmonary fibrosis

FibroGen, Inc. today announced initiation of an open-label phase 2 study to evaluate the safety, tolerability, and efficacy of FG-3019, a human monoclonal antibody against connective tissue growth factor (CTGF), in individuals with idiopathic pulmonary fibrosis (IPF), a chronic, progressive, fatal lung disease for which there are no FDA-approved therapies.

13 Jan 2011

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).

7 Jan 2011