Dyspnea News and Research

RSS

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

Data from Phase IV study of Bystolic tablets in Hispanic patients with hypertension presented at ASH 2010

Forest Laboratories, Inc. today presented data from a Phase IV study evaluating the effects of Bystolic (nebivolol) tablets in Hispanic patients with hypertension at the 2010 annual scientific meeting of the American Society of Hypertension.

4 May 2010

New data on Cimzia for Crohn’s Disease treatment to be demonstrated at DDW 2010

Studies and analyses of the Crohn’s Disease (CD) treatment Cimzia® (certolizumab pegol) demonstrating new data will be exhibited at Digestive Disease Week (DDW) 2010, taking place in New Orleans from May 1-5, 2010.

30 Apr 2010

PROVENGE receives FDA approval for treatment of CRPC

Dendreon Corporation today announced that the U.S. Food and Drug Administration has approved PROVENGE (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer.

30 Apr 2010

High incidence of MDS among seniors, elderly at increased risk of premature death: Study

Myelodysplastic syndromes - a group of serious blood cancers - are nearly five times more common in seniors than previously thought, according to a new study by researchers from the John Theurer Cancer Center at Hackensack University Medical Center.

27 Apr 2010

Data from Phase 2 clinical trials of Hematide/peginesatide presented at NKF Annual Meeting

Affymax, Inc. and Takeda Global Research & Development Center, Inc., U.S., today announced data from several post hoc analyses of Phase 2 clinical trials that evaluated Hematide/peginesatide in dialysis patients with anemia in chronic kidney disease. The data provide hypotheses for further investigation of this agent in anemia management in this patient population.

16 Apr 2010

Genzyme presents 4-year follow-up data from Phase 2 MS trial at neurology meeting

Genzyme Corporation today reported four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial showing an estimated 71 percent of alemtuzumab treated patients remain free of clinically-active disease as much as three years after most patients received their last course of the investigational compound. The data were presented at the American Academy of Neurology annual meeting.

15 Apr 2010

Alkermes submits VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that it has submitted a supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) to the U.S. Food and Drug Administration (FDA) for approval as a treatment for opioid dependence. The company requested a priority review for its sNDA and if granted by the FDA, it would mean a six month review timeline.

13 Apr 2010

FDA approves TachoSil adjunctive hemostatic agent for use in cardiovascular surgery

Baxter International Inc. and Nycomed today announced the U.S. Food and Drug Administration (FDA) approval of TachoSil (Absorbable Fibrin Sealant Patch) for use as an adjunct to hemostasis in cardiovascular surgery. TachoSil is the first and only adjunctive hemostatic agent available in the U.S. that combines a collagen patch with a coating of human coagulation factors.

From Baxter International Inc. 7 Apr 2010

EMA validates InterMune's pirfenidone MAA for IPF

InterMune, Inc. today announced that the company's Marketing Authorization Application (MAA), submitted on March 2 seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, was validated by the European Medicines Agency (EMA). Validation of the MAA by the EMA indicates that the application is complete and that the review process will begin on March 24. The proposed trade name for pirfenidone in both the United States and Europe is Esbriet®.

23 Mar 2010

FDA's Advisory Committee votes 9-3 to recommend approval of Esbriet for treatment of patients with IPF

InterMune, Inc. announced today that the U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of Esbriet® (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.

9 Mar 2010

NASDAQ halts trading of InterMune's common stock, FDA PADAC to discuss pirfenidone NDA

InterMune, Inc. announced that NASDAQ has today halted trading of InterMune's common stock. The Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration meets today to review and discuss the company's New Drug Application for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis.

9 Mar 2010

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

InterMune, Inc. announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to review the New Drug Application (NDA) for pirfenidone, InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function. The proposed trade name for pirfenidone is Esbriet®.

5 Mar 2010

InterMune seeks European marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.

2 Mar 2010

New treatments for heart disease

Two studies published in the latest issue of Cell Transplantation (18:12) may lead to new treatments for the treatment of heart diseases. The first study, carried out by a team of Brazilian researchers, found that cell transplantation of bone marrow mononuclear cells (BMMCs) directly into the heart benefited patients suffering from refractory angina.

24 Feb 2010

Forest Laboratories' Bystolic tablets for treatment of stable CHF failed to receive FDA approval

Forest Laboratories, Inc. announced today that the U.S. Food and Drug Administration did not approve the additional indication for Bystolic® (nebivolol) tablets as a treatment for stable chronic heart failure (CHF) as requested in the company’s Supplemental New Drug Application (sNDA).

23 Feb 2010

Standard checklist for home palliative sedation

Can patients near death safely receive sedation at home, fully respecting their own and their families' wishes? This practice, which is on the rise, is coming under increasing scrutiny and debate by palliative care researchers and practitioners.

19 Feb 2010

Genzyme announces 2-year data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation announced today two-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 (formerly Genz-112638). Continued improvements were observed across all endpoints, including bone disease, at the two-year timepoint, compared with baseline. The two-year results were presented for the first time today at the Lysosomal Disease Network WORLD Symposium in Miami, Fla.

12 Feb 2010

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Patients with gastrointestinal stromal tumours (GIST) can now take action at an earlier stage of this rare form of cancer to reduce the risk of their disease returning following surgery. Novartis Pharmaceuticals Canada announced today that Gleevec* (imatinib mesylate) has received conditional approval by Health Canada for the adjuvant (post-surgical) treatment of adult patients who are at intermediate to high risk of disease recurrence following the surgical removal of GIST.

27 Jan 2010

Health Canada approves Novartis' Afinitor to treat patients with mRCC

Novartis Pharmaceuticals Canada Inc. (Novartis) announced today that Afinitor(R) (everolimus), a once-daily oral cancer treatment, has been approved by Health Canada for patients with metastatic renal cell carcinoma (mRCC), also known as advanced kidney cancer, after failure of initial treatment with VEGF-receptor targeted therapies Sutent(R) (sunitinib) or Nexavar(R) (sorafenib).

20 Jan 2010

Positive top-line results from Phase III study of aclidinium bromide announced

orest Laboratories, Inc. and Almirall, S.A. (ALM.MC) today announced positive top-line results from ACCORD COPD I, a three-month Phase III study comparing aclidinium 200µg and 400µg BID versus placebo.

7 Jan 2010