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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.
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Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Nektar Therapeutics reported today that partner Baxter International Inc. announced that the company has submitted a new drug application (NDA) to Japan's Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE [Antihemophilic Factor (Recombinant)] for patients over 12 years of age with hemophilia A. [More]
Eisai, Arena complete two Phase 1 registrational trials for once-daily formulation of lorcaserin

Eisai, Arena complete two Phase 1 registrational trials for once-daily formulation of lorcaserin

Eisai Inc. and Arena Pharmaceuticals, Inc. today announced the completion of two Phase 1 registrational clinical trials that Eisai and Arena believe demonstrate bioequivalence of an investigational once-daily extended release formulation of lorcaserin, as compared to the twice-daily immediate release formulation approved by the US Food and Drug Administration and marketed as BELVIQ. [More]
Pharmacyclics announces positive results from IMBRUVICA Phase II study in WM patients

Pharmacyclics announces positive results from IMBRUVICA Phase II study in WM patients

Pharmacyclics, Inc. today announced longer-term data from a Phase II investigator-initiated study showing Waldenstrom's macroglobulinemia (WM) patients treated with IMBRUVICA (ibrutinib) experienced sustained disease control with an overall response rate (ORR) of 91% after a median of 19.1 months of treatment and a 2-year overall survival (OS) rate of 95%. [More]
New simeprevir clinical data to be presented at EASL's International Liver Congress 2015

New simeprevir clinical data to be presented at EASL's International Liver Congress 2015

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress 2015 of the European Association for the Study of the Liver taking place in Vienna from April 22-26. [More]
Astellas Pharma, Medivation announce topline results from enzalutamide Phase 2 STRIVE trial

Astellas Pharma, Medivation announce topline results from enzalutamide Phase 2 STRIVE trial

Astellas Pharma Inc. and Medivation, Inc. today announced topline results from the Phase 2 STRIVE trial comparing enzalutamide with bicalutamide in a study population of men with non-metastatic or metastatic castration-resistant prostate cancer. [More]
Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira, Inc., a global leader in biosimilars and the world's leading provider of injectable drugs and infusion technologies, announces the availability of INFLECTRA (infliximab) in Canada, the country's first subsequent entry biologic (SEB) monoclonal antibody (mAb) therapy. [More]
Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. [More]
New pre-clinical, clinical data for IMBRUVICA to be highlighted at AACR Annual Meeting

New pre-clinical, clinical data for IMBRUVICA to be highlighted at AACR Annual Meeting

Pharmacyclics, Inc. today announced that new pre-clinical and clinical data for ibrutinib (IMBRUVICA) will be highlighted at the 2015 American Association for Cancer Research Annual Meeting to be held April 18 – 22, 2015, in Philadelphia, PA. [More]
Combining CT measurements assists pulmonary hypertension prediction

Combining CT measurements assists pulmonary hypertension prediction

Research suggests that combining pulmonary artery and ventricular measurements improves the chances of identifying pulmonary hypertension in patients undergoing computed tomography pulmonary angiography. [More]
United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. [More]
FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

Astellas today announced that the U.S. Food and Drug Administration has approved its New Drug Application (NDA) for the use of CRESEMBA (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). [More]
Kyprolis demonstrates superiority over velcade in patients with relapsed multiple myeloma in head-to-head endeavor trial

Kyprolis demonstrates superiority over velcade in patients with relapsed multiple myeloma in head-to-head endeavor trial

Patients Receiving Kyprolis Lived Twice as Long without Disease Progression [More]
Study shows heart valve repair can benefit patients with mitral regurgitation

Study shows heart valve repair can benefit patients with mitral regurgitation

Patients with severe mitral regurgitation (MR) often suffer from psycho-emotional symptoms, such as depression and anxiety, but after undergoing mitral valve repair surgery patients experience a marked improvement in emotional and physical wellbeing, according to an article in the March 2015 issue of The Annals of Thoracic Surgery. [More]
Kaleo, CHMI partner to reduce prescription drug-related deaths

Kaleo, CHMI partner to reduce prescription drug-related deaths

Kaleo, a privately-held pharmaceutical company, today announced a national strategic partnership with the Clinton Health Matters Initiative, an initiative of the Clinton Foundation, that will help support its goal of cutting prescription drug-related deaths in half, saving approximately 10,000 lives over five years. [More]
OncoGenex executes initial agreement with Teva to regain rights to custirsen

OncoGenex executes initial agreement with Teva to regain rights to custirsen

OncoGenex Pharmaceuticals, Inc. today announced that it has executed an initial agreement with Teva Pharmaceutical Industries Ltd. to regain rights to custirsen, an investigational compound currently being evaluated in Phase 3 clinical development as a treatment for prostate and lung cancers. [More]
FDA approves Novo Nordisk’s weight loss injection, Saxenda

FDA approves Novo Nordisk’s weight loss injection, Saxenda

Novo Nordisk today announced that the Food and Drug Administration (FDA) has approved the new drug application (NDA) for Saxenda® (liraglutide [rDNA origin] injection), the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management. [More]
Lilly receives FDA approval for CYRAMZA (ramucirumab)

Lilly receives FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its third U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab). [More]
Pharmacyclics receives BayBio's 2014 Pantheon DiNA Award for Outstanding Company

Pharmacyclics receives BayBio's 2014 Pantheon DiNA Award for Outstanding Company

Pharmacyclics, Inc. today announced that it has been awarded BayBio's 2014 Pantheon DiNA Award for Outstanding Company for its rapid development and commercialization of IMBRUVICA (ibrutinib). The award was presented at BayBio's 11th Annual Pantheon DiNA Awards ceremony in San Francisco. [More]
IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL

IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL

New IMBRUVICA (ibrutinib) Phase II data announced by Pharmacyclics, Inc. today demonstrates its potential utility as a combination therapy when used with rituximab. Data suggest that the overall efficacy and safety profile of IMBRUVICA is well tolerated when combined with rituximab in patients with relapsed or refractory mantle cell lymphoma (MCL). [More]
Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Results from the Phase 2 RESONATE-17 (PCYC-1117) study show IMBRUVICA (ibrutinib) was associated with an 82.6 percent investigator-assessed overall response rate (ORR; the primary endpoint) and a 79 percent progression-free survival (PFS) rate at 12 months in people living with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have a genetic mutation known as deletion 17p (del 17p). [More]
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