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 seeks re-examination of EMA CHMP opinion on FOLOTYN for PTCL

Allos Therapeutics, Inc. today announced that it has submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued in January by the EMA's Committee For Medicinal Products for Human Use (CHMP) for conditional approval of FOLOTYN (pralatrexate injection) for the treatment of patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy.

30 Jan 2012

Baxter commences BAX 855 Phase I trial in hemophilia A

Baxter International Inc. today announced the dosing of the first patients in a Phase I clinical trial of its lead investigational candidate, BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor VIII (rFVIII) protein.

From Baxter International Inc. 5 Jan 2012

CMS assigns J-code for Pharmaxis ARIDOL Bronchial Challenge Test Kit

Pharmaxis, Inc. today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a product-specific billing code, or J-code, for ARIDOL (mannitol inhalation powder) Bronchial Challenge Test Kit.

4 Jan 2012

FDA invites Amgen for ODAC meeting on XGEVA sBLA to treat castration-resistant prostate cancer

Amgen today announced the U.S. Food and Drug Administration has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

30 Dec 2011

UCB initiates EXXELERATE study in rheumatoid arthritis

UCB today announced the start of the EXXELERATE study which will evaluate the short- and long-term efficacy of Cimzia (certolizumab pegol) plus methotrexate (MTX) compared with that of Humira(adalimumab) plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). The start of this study confirms previously announced plans.

21 Dec 2011

Baxter receives FDA approval for ADVATE to prevent hemophilia A

Baxter International Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A.

From Baxter International Inc. 17 Dec 2011

Updated data from Novartis Afinitor plus everolimus Phase III study on advanced breast cancer

Updated results of a Phase III study of Afinitor (everolimus) tablets plus exemestane, a hormonal therapy, show everolimus provided additional time women with advanced breast cancer lived without their disease progressing.

8 Dec 2011

Amgen's XGEVA delays onset of bone metastases in men with prostate cancer

Amgen announced today the publication of results from a Phase 3 trial (the '147 study) that evaluated XGEVA (denosumab) for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer.

16 Nov 2011

Positive results from Alkermes VIVITROL addiction study

Alkermes plc today presented positive results from a long-term study of VIVITROL (naltrexone for extended-release injectable suspension) at the 24th Annual U.S. Psychiatric and Mental Health Congress in Las Vegas, NV.

10 Nov 2011

UCB to sponsor several key sets of Cimzia data on RA at ACR 2011 meeting

UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, is proud to sponsor several key sets of Cimzia (certolizumab pegol) data at the American College of Rheumatology's 2011 Annual Scientific Meeting in Chicago, November 5-9.

7 Nov 2011

Human Genome Sciences to present abstracts regarding BENLYSTA, SLE at ACR/ARHP meeting

Human Genome Sciences, Inc. announced today that several abstracts related to BENLYSTA (belimumab) and systemic lupus erythematosus will be presented at the annual meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals, being held in Chicago, IL from November 4 to November 9, 2011.

5 Nov 2011

Vitamin D levels not related to acute exacerbations of chronic obstructive pulmonary disease

Vitamin D levels are not related to acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in patients with severe COPD, according to a large prospective cohort study involving 973 North American patients. The findings were published online ahead of the print edition of the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine.

4 Nov 2011

Allos third quarter net loss decreases to $11.2 million

Allos Therapeutics, Inc. today reported financial results for the three months ended September 30, 2011.

3 Nov 2011

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term overall survival (OS) data from the VISTA trial.

2 Nov 2011

UCB to present new data on Cimzia at ACG annual scientific meeting

UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, will present new data on Cimzia at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place in Washington D.C. from October 28 to November 2.

1 Nov 2011

FDA's ODAC to review Affymax peginesatide NDA for treatment of CKD-associated anemia

Affymax, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session.

24 Oct 2011

Allos terminates AMAG merger agreement with AMAG

Allos Therapeutics, Inc. announced today that the Agreement and Plan of Merger and Reorganization entered into by and among Allos, AMAG and Alamo Acquisition Sub, Inc. on July 19, 2011, as amended on August 8, 2011, has been terminated.

22 Oct 2011

Allos to complete merger with AMAG Pharmaceuticals

Allos Therapeutics, Inc. today announced that it continues to work with AMAG Pharmaceuticals, Inc. towards the completion of their merger, pending stockholder approval and satisfaction of the other conditions to closing described in Allos' definitive proxy statement filed with the SEC on September 15, 2011.

11 Oct 2011

Boehringer Ingelheim receives FDA approval for COMBIVENT RESPIMAT to treat COPD

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler.

10 Oct 2011

The US Oncology Network affiliate treats advanced prostate cancer patients with PROVENGE

David, a 67-year-old father of three and soon to be first-time grandfather, felt too young to be diagnosed with prostate cancer. "I felt great," he said. "I had no symptoms." David, under the advisement of his oncologist, decided to be treated with PROVENGE (sipuleucel-T), the first in a new therapeutic class known as autologous cellular immunotherapies.

1 Oct 2011