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BIOTRONIK ProMRI ICD trial expansion achieves FDA approval

BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved a significant expansion of its ongoing ProMRI® trial.

23 May 2014

NCCN receives $2M grant to evaluate effectiveness of volasertib in treatment of hematologic malignancies

The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) has been awarded a $2-million grant from Boehringer Ingelheim Pharmaceuticals, Inc.

23 May 2014

Agios Pharmaceuticals to present AG-221 Phase 1 study results at EHA meeting

Agios Pharmaceuticals, Inc., a leader in the fields of cancer metabolism and inborn errors of metabolism (IEMs), today announced that new clinical data from the Phase 1 study of AG-221, an orally available, selective, potent inhibitor of the mutated IDH2 protein, will be highlighted in an oral presentation at the 19th Congress of the European Hematology Association (EHA) taking place June 12 -15, 2014 in Milan, Italy.

22 May 2014

SinoVeda announces positive clinical results for EffectiCal in post-menopausal women

SinoVeda Canada Inc. today announces positive clinical results for EffectiCal® from its 24-week double-blind, randomized comparative clinical trial in post-menopausal women.

22 May 2014

Phase 3 data of VIVACITO study evaluating effect of T+O FDC in COPD presented at ATS conference

Boehringer Ingelheim today presented results of the VIVACITO® (NCT01559116) study, the first Phase 3 data to be reported from the TOviTO® clinical trial program, evaluating the effect of the fixed-dose combination of tiotropium and olodaterol (T+O FDC) delivered via the Respimat® inhaler on lung function in people with chronic obstructive pulmonary disease (COPD).

22 May 2014

Genprex initiates Phase II clinical trial of Oncoprex for late-stage lung cancer patients

Genprex, Inc. announced today that it has enrolled the first patient in a clinical trial evaluating its lead product candidate Oncoprex in combination with erlotinib (Tarceva) for late-stage lung cancer patients.

21 May 2014

Isis Pharmaceuticals starts Phase 1 clinical study of ISIS-PKKRx to treat patients with HAE

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it initiated a Phase 1 clinical study of ISIS-PKKRx. ISIS-PKKRx is an antisense drug in development to treat patients with hereditary angioedemia (HAE).

21 May 2014

Recruiting more Hispanics to cancer clinical trials crucial to reducing health disparities

Hispanics are the fastest-growing demographic group in the United States, and they suffer from major health disparities, including higher rates of cancers of the cervix, stomach and liver.

20 May 2014

Sanofi presents Phase II trial results for investigational vaccine for prevention of CDI

Sanofi Pasteur, the vaccines division of Sanofi, presented Phase II (H-030-012) trial results for an investigational vaccine for the prevention of Clostridium difficile infection at the 114th General Meeting of the American Society for Microbiology.

20 May 2014

Juventas presents positive trial results of JVS-100 drug delivered by Biocardia’s Helix transendocardial system

BioCardia®, Inc., a leader in cardiovascular regenerative medicine, today announced the presentation by Juventas Therapeutics of their positive four-month results for their STOP-HF Trial.

20 May 2014

GSK reports positive results from Incruse Ellipta and Advair Diskus combination therapy in COPD patients

GlaxoSmithKline plc today presented data at the American Thoracic Society (ATS) from a late-stage clinical study.

20 May 2014

Elotuzumab granted Breakthrough Therapy Designation for treatment of multiple myeloma

Bristol-Myers Squibb Company and AbbVie today announced that the U.S. Food and Drug Administration (FDA) has granted elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies.

20 May 2014

Researchers identify drugs to slow progression of idiopathic pulmonary fibrosis

Researchers in separate clinical trials found two drugs slow the progression of idiopathic pulmonary fibrosis, a fatal lung disease with no effective treatment or cure, and for which there is currently no therapy approved by the Food and Drug Administration.

19 May 2014

Auxilium Pharmaceuticals presents new XIAFLEX clinical trial data at AUA Meeting

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, today announced that new analyses of data were presented from its clinical program and pivotal IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the Phase 3 studies that evaluated XIAFLEX® (collagenase clostridium histolyticum or CCH) for the treatment of Peyronie's disease (PD).

19 May 2014

Shire intends to submit NDA for lifitegrast to treat dry eye disease

Following a May 15, 2014, meeting with the U.S. Food and Drug Administration (FDA), Shire plc, the global specialty biopharmaceutical company, announces today that it intends to submit a New Drug Application for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults in the first-quarter 2015, as we complete remaining chemistry and manufacturing work.

19 May 2014

PARADIGM-HF trial of LCZ696 for chronic heart failure stopped early for benefit

The PARADIGM-HF trial has been stopped early for a benefit to patients that was overwhelmingly statistically significant.

19 May 2014

Phase III INPULSIS trials show nintedanib slows disease progression in patients with IPF

Results from the Phase III INPULSIS™ trials, published online today in the New England Journal of Medicine, show nintedanib significantly slowed disease progression in patients with idiopathic pulmonary fibrosis (IPF).

19 May 2014

FibroGen’s Phase 2a study supports safety and efficacy of FG-3019 in IPF patients

FibroGen, Inc. (FibroGen) announced today the presentation of clinical data at the American Thoracic Society (ATS) International Conference supporting the safety and efficacy of FG-3019 in patients with idiopathic pulmonary fibrosis (IPF), a debilitating and life-threatening lung disease for which there is currently no approved therapy in the United States.

19 May 2014

TEVA presents results from real-life, observational study of QVAR at ATS 2014 International Conference

Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced that results from a real-life, retrospective, observational study of QVAR- will be presented at the American Thoracic Society (ATS) 2014 International Conference in San Diego on May 18, 2014.

19 May 2014

Kamada announces top-line results from Phase II/III trial for treatment of inherited emphysema

Kamada Ltd., a plasma-derived protein therapeutics company focused on orphan indications, announces preliminary top-line results from the Phase II/III pivotal clinical trial in Europe and Canada of the Company's proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD or inherited emphysema).

16 May 2014

Drug Trial News

BIOTRONIK ProMRI ICD trial expansion achieves FDA approval

NCCN receives $2M grant to evaluate effectiveness of volasertib in treatment of hematologic malignancies

Agios Pharmaceuticals to present AG-221 Phase 1 study results at EHA meeting

SinoVeda announces positive clinical results for EffectiCal in post-menopausal women

Phase 3 data of VIVACITO study evaluating effect of T+O FDC in COPD presented at ATS conference

Genprex initiates Phase II clinical trial of Oncoprex for late-stage lung cancer patients

Isis Pharmaceuticals starts Phase 1 clinical study of ISIS-PKKRx to treat patients with HAE

Recruiting more Hispanics to cancer clinical trials crucial to reducing health disparities

Sanofi presents Phase II trial results for investigational vaccine for prevention of CDI

Juventas presents positive trial results of JVS-100 drug delivered by Biocardia’s Helix transendocardial system

GSK reports positive results from Incruse Ellipta and Advair Diskus combination therapy in COPD patients

Elotuzumab granted Breakthrough Therapy Designation for treatment of multiple myeloma

Researchers identify drugs to slow progression of idiopathic pulmonary fibrosis

Auxilium Pharmaceuticals presents new XIAFLEX clinical trial data at AUA Meeting

Shire intends to submit NDA for lifitegrast to treat dry eye disease

PARADIGM-HF trial of LCZ696 for chronic heart failure stopped early for benefit

Phase III INPULSIS trials show nintedanib slows disease progression in patients with IPF

FibroGen’s Phase 2a study supports safety and efficacy of FG-3019 in IPF patients

TEVA presents results from real-life, observational study of QVAR at ATS 2014 International Conference

Kamada announces top-line results from Phase II/III trial for treatment of inherited emphysema

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