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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

Data from phase III trials supports safety, efficacy of linagliptin in treating T2D in African-American adults

Data from a retrospective pooled analysis of eight phase III trials (two 18-week and six 24-week) of linagliptin 5 mg once-daily, showed reductions from baseline A1c at 18 (eight trials) and 24 (six trials) weeks compared to placebo in African-American adults with type 2 diabetes (T2D),

16 May 2014

New research shows decline in clinical trials handled by CROs

The number of clinical trials started by leading contract research organisations (CROs) dropped by 50% between 2011 and 2013, according to new research from global pharmaceutical analyst firm Datamonitor Healthcare.

16 May 2014

Bristol-Myers Squibb announces study results of nivolumab drug in patients with renal cell carcinoma

Bristol-Myers Squibb Company today announced results from a Phase 2 and a Phase 1b study of its investigational PD-1 immune checkpoint inhibitor nivolumab in patients with advanced or metastatic renal cell carcinoma (RCC), commonly known as kidney cancer.

16 May 2014

Bristol-Myers Squibb reports updated survival data from Phase 1b study of advanced melanoma

Bristol-Myers Squibb Company today announced updated survival data from the advanced melanoma cohort of Phase 1b study.

16 May 2014

Telormedix completes Phase II trial of Vesimune in CIS of the bladder

Telormedix, a clinical stage biopharmaceutical company focused on TLR7 agonists in the treatment of cancer and inflammatory diseases, today announced that it has successfully completed a Phase II trial, conducted under an IND, of Vesimune (TMX-101) in CIS (carcinoma in situ) of the bladder.

16 May 2014

NovaBay completes enrollment of patients in global Phase 2b viral conjunctivitis trial

NovaBay Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing non-antibiotic, topical antimicrobial products, today announced it has completed enrollment of patients in its global Phase 2b viral conjunctivitis trial, BAYnovation.

16 May 2014

Drug Trial News

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

Data from phase III trials supports safety, efficacy of linagliptin in treating T2D in African-American adults

New research shows decline in clinical trials handled by CROs

Bristol-Myers Squibb announces study results of nivolumab drug in patients with renal cell carcinoma

Bristol-Myers Squibb reports updated survival data from Phase 1b study of advanced melanoma

Telormedix completes Phase II trial of Vesimune in CIS of the bladder

NovaBay completes enrollment of patients in global Phase 2b viral conjunctivitis trial

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

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