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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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FDA expands use of Opdivo + Yervoy Regimen for BRAF V600 mutant and wild-type advanced melanoma

FDA expands use of Opdivo + Yervoy Regimen for BRAF V600 mutant and wild-type advanced melanoma

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved Opdivo in combination with Yervoy for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. [More]
Results from STRIVE trial of enzalutamide versus bicalutamide in CRPC published in Journal of Clinical Oncology

Results from STRIVE trial of enzalutamide versus bicalutamide in CRPC published in Journal of Clinical Oncology

Astellas US LLC, a United States (U.S.) subsidiary of Tokyo-based Astellas Pharma Inc., and Medivation, Inc. today announced that results from the STRIVE trial of enzalutamide compared to bicalutamide in men with castration-resistant prostate cancer (CRPC) were published in the Journal of Clinical Oncology. [More]
Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced initial results from a Phase 3 clinical trial of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)]. [More]
Lilly, Merck announce another immuno-oncology collaboration

Lilly, Merck announce another immuno-oncology collaboration

Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, today announced another immuno-oncology collaboration that will evaluate abemaciclib (LY2835219), Lilly's cyclin-dependent kinase (CDK) 4 and 6 inhibitor, and Merck's KEYTRUDA (pembrolizumab) in a Phase I study across multiple tumor types. [More]
Opdivo (nivolumab) approved to treat patients with advanced renal cell carcinoma

Opdivo (nivolumab) approved to treat patients with advanced renal cell carcinoma

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. [More]
Lilly, Merck expand oncology clinical trial collaboration

Lilly, Merck expand oncology clinical trial collaboration

Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, today announced the extension of an existing collaboration to evaluate the safety and efficacy of the combination of Lilly's ALIMTA (pemetrexed for injection) and Merck's KEYTRUDA (pembrolizumab) in a pivotal Phase III study in first-line nonsquamous non-small cell lung cancer (NSCLC). [More]
FDA approves Yondelis (trabectedin) for treatment of specific soft tissue sarcomas

FDA approves Yondelis (trabectedin) for treatment of specific soft tissue sarcomas

The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). [More]
Yoga exercise as effective as traditional pulmonary rehab in improving pulmonary function in COPD patients

Yoga exercise as effective as traditional pulmonary rehab in improving pulmonary function in COPD patients

Researchers from the Department of Pulmonary Medicine and Sleep Disorders and All India Institute of Medical Sciences, New Delhi, India, studied the effects of yoga as a form of pulmonary rehabilitation on markers of inflammation in the body. [More]
Takeda highlights safety, efficacy of vedolizumab for UC and CD at ACG Annual Scientific Meeting

Takeda highlights safety, efficacy of vedolizumab for UC and CD at ACG Annual Scientific Meeting

Takeda Pharmaceuticals, U.S.A., Inc., today announced that data highlighting the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), will be presented during the 2015 American College of Gastroenterology Annual Scientific Meeting in Honolulu, Hawaii, held on October 16-21. [More]
FDA grants accelerated approval for Keytruda to treat patients with advanced NSCLC

FDA grants accelerated approval for Keytruda to treat patients with advanced NSCLC

The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors. [More]
Philips showcases latest patient-driven sleep and respiratory solutions at the European Respiratory Society International Congress 2015

Philips showcases latest patient-driven sleep and respiratory solutions at the European Respiratory Society International Congress 2015

Philips Respironics, a business of Royal Philips, will showcase its latest portfolio of sleep-disordered breathing and respiratory solutions September 26-29 at the European Respiratory Society (ERS) International Congress 2015 in Amsterdam. At booth 1.H_01, Hall 1, clinicians can experience the latest Philips sleep-disordered breathing solutions and new options for COPD management that connect and support the patient, clinician and caregiver to improve patient care and help patients to live active lives. [More]
Amgen gets positive CHMP opinions for Kyprolis (carfilzomib) and BLINCYTO (blinatumomab)

Amgen gets positive CHMP opinions for Kyprolis (carfilzomib) and BLINCYTO (blinatumomab)

"We are pleased to receive positive CHMP opinions for Kyprolis and BLINCYTO as this is an important step in providing new treatment options for patients in Europe with rare forms of cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. [More]
Amgen, Xencor partner to develop and commercialize new therapeutics for cancer immunotherapy, inflammation

Amgen, Xencor partner to develop and commercialize new therapeutics for cancer immunotherapy, inflammation

Amgen and Xencor, Inc. announced today that the two companies have entered into a research and license agreement to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation. [More]

Bracket completes EXACT e-Diary Certification program on Android smartphone and tablet

Bracket, one of the industry's leading eCOA solutions providers today announced that it has completed the e-Diary Certification program with Evidera™ for the EXACT patient daily e-Diary on both an Android smartphone, and an Android Tablet. [More]
ieCrowd announces achievement of major milestone in commercial development of Smart Oxygen device

ieCrowd announces achievement of major milestone in commercial development of Smart Oxygen device

ieCrowd today announced the achievement of an important milestone in the commercial development of the company's supplemental oxygen delivery device, Smart Oxygen. The Smart Oxygen device, being developed by ieCrowd's subsidiary Smart Oxygen Solutions, automatically adjusts to a patient's changing demand for oxygen based on level of activity. [More]
FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. [More]
BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. [More]
Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections. [More]
Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Amgen today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Kyprolis (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. [More]
IMBRUVICA (ibrutinib) approved in Europe for treatment of Waldenstrom's macroglobulinemia

IMBRUVICA (ibrutinib) approved in Europe for treatment of Waldenstrom's macroglobulinemia

Today AbbVie announced the European Commission granted marketing authorization for IMBRUVICA (ibrutinib) as the first treatment option available in all 28 member states of the European Union for the treatment of Waldenstrom's macroglobulinemia (WM), a rare, slow growing blood cancer, in adult patients who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. [More]
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