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.

Synta Pharmaceuticals updates its Phase 3 SYMMETRY trial results at the Melanoma XIII Conference

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that additional results from its Phase 3 trial (SYMMETRYSM) of elesclomol in combination with paclitaxel in metastatic melanoma was presented at the Perspectives in Melanoma XIII Conference by Steven O’Day, M.D., principal investigator and Chief of Research and Director of the Melanoma Program at the Angeles Clinic in Santa Monica, California.

12 Oct 2009

BioDelivery Sciences' partner Meda to launch ONSOLIS for managing breakthrough pain

BioDelivery Sciences International, Inc. announced that its commercial partner Meda will launch the FDA-approved ONSOLIS (fentanyl buccal soluble film) next week for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

8 Oct 2009

Schering-Plough receives FDA recommendation approval for PEGINTRON

Schering-Plough Corp. announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma.

6 Oct 2009

FOLOTYN available for commercial sale in the United States

Allos Therapeutics, Inc. today announced that FOLOTYN (pralatrexate injection) is now available for commercial sale in the United States. The U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) on September 24, 2009. This indication is based on overall response rate.

6 Oct 2009

FDA grants Fast Track designation to Corthera's relaxin for treating acute heart failure

Corthera Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to relaxin, the company's investigational drug for the treatment of acute heart failure (AHF). The Fast Track program facilitates the development and expedites the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

3 Oct 2009

FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

28 Sep 2009

Phase 2 trial results of Bayer's Nexavar in combination with capecitabine announced

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the full results from their first collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trial showing that Nexavar(R) (sorafenib) tablets in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression-free survival in patients with advanced breast cancer.

23 Sep 2009

Millennium's sNDA for VELCADE granted priority review by the FDA

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the Company’s supplemental new drug application (sNDA) for VELCADE. The sNDA contains long-term overall survival (OS) data from the landmark VISTA trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

19 Sep 2009

InterMune and National Jewish Health to collaborate in the research of idiopathic pulmonary fibrosis

InterMune, Inc. (Nasdaq: ITMN) today announced that it will be collaborating with National Jewish Health(R)( )investigators in order to help further the research of inherited genetic factors that may play a role in idiopathic pulmonary fibrosis (IPF). InterMune will provide researchers at National Jewish with access to DNA collected from patients who participated in the Company's Phase 3 clinical trials in IPF for both pirfenidone (CAPACITY trials) and Actimmune(R) (interferon gamma-1b) (INSPIRE).

17 Sep 2009

Clinical studies reveal treatment with pirfenidone is safe and well-tolerated

InterMune, Inc. (Nasdaq: ITMN) today announced that the results of a comprehensive review of safety data from four clinical studies were presented at the 2009 European Respiratory Society Annual Congress in Vienna, Austria by Dr. Ulrich Costabel of the Ruhrlandklinik, Essen, Germany.

14 Sep 2009

Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Genzyme Corporation reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab.

14 Sep 2009

AVONEX results in fewer injection site reactions, according to a clinical study

Data from an observational phase IV study of 499 patients entitled The Swiss MS Skin Project show that multiple sclerosis (MS) patients taking AVONEX (interferon beta-1a IM) reported significantly fewer injection site reactions (ISRs) compared to patients on Betaferon- (interferon beta-1b), Copaxone- (glatiramer Acetate) or Rebif - (interferon beta-1a).

13 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

PROTECT clinical study aimed at the assessment of rolofylline effects

Despite the promising findings of the PROTECT Pilot study, the larger PROTECT trial found no difference with rolofylline versus placebo with respect of the primary and main secondary end-points of the study. Although more rolofylline patients than placebo patients experienced moderate or marked dyspnea improvement at 24 and 48 hours from randomization, this was counterbalanced by a lack of effect on persistent renal impairment. Lastly, the risk of important neurological events was increased in patients on rolofylline.

2 Sep 2009

Cimzia approved for treating adult patients with rheumatoid arthritis

UCB Canada Inc. announced today that Health Canada has approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

1 Sep 2009

Researchers develop an index scale to help physicians predict a patient's risk of dying from COPD

Researchers have developed an index scale to help physicians predict a patient's risk of dying from chronic obstructive pulmonary disease (COPD). The ADO index can help physicians assess the severity of a patient's illness to determine the appropriate level of treatment. COPD, which comprises emphysema and chronic bronchitis, is a major public health problem and it is the fourth leading cause of death in the U.S. The study of the ADO index is published in the August 29 edition of the Lancet.

29 Aug 2009

Clinical data added to ORENCIA labeling help treat patients with rheumatoid arthritis

Bristol-Myers Squibb Company announced today that clinical data added to the labeling for ORENCIA (abatacept) support use of ORENCIA for patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration.

27 Aug 2009

InterMune receives $20 million event payment from Roche for initiating the Phase 2b trial of RG7227/ ITMN-191

Roche (SIX: ROG.VX; RO.S, OTCQX: RHHBY) and InterMune, Inc. (Nasdaq: ITMN) today announced that the first patient has been dosed in a Phase 2b study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with PEGASYS(R) (pegylated interferon alfa-2a) and COPEGUS(R) (ribavirin). The study, to be conducted at 45 sites globally, will further define the safety and efficacy profile of RG7227/ ITMN-191, for a treatment duration of up to 24 weeks. Approximately 300 treatment-naive patients chronically infected with HCV genotype 1 - the most difficult to treat form of the virus - will participate.

20 Aug 2009