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Discovery Laboratories initiates AEROSURF phase 2b clinical trial in premature infants with RDS

Discovery Laboratories, Inc., a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that it has initiated its AEROSURF phase 2b clinical trial in premature infants 26 to 32 weeks gestational age (GA) receiving non-invasive nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS).

29 Dec 2015

Myostatin antibody shows promise in treating age-related decline in muscle mass and power

A proof-of-concept, phase 2 trial by an international research team has found promising results for a myostatin antibody in treating the decline in muscle mass and power associated with aging.

29 Dec 2015

Rich Pharmaceuticals obtains FDA approval to begin Phase 1/2 study in AML and MDS patients

Rich Pharmaceuticals, Inc. is pleased to announce that the Company has received approval from the U.S. Food and Drug Administration to commence its Phase 1/2 clinical for the treatment of Acute Myelocytic Leukemia (AML) and Myelodysplastic Syndrome (MDS) patients.

28 Dec 2015

Azithromycin remains effective in treatment of urogenital chlamydia, confirms UAB study

In one of the most tightly controlled trials ever conducted of drugs used to treat sexually transmitted infections, researchers at the University of Alabama at Birmingham have confirmed that azithromycin remains effective in the treatment of urogenital chlamydia.

24 Dec 2015

Positive interim results from TWIB's AC-201 CR Phase 2 study for hyperuricemia and gout

TWi Biotechnology Inc. today announced interim results from the ongoing Phase 2 proof of concept clinical study evaluating AC-201 CR as an oral uricosuric and anti-inflammatory agent for the treatment of hyperuricemia and prevention of gout flares combining with febuxostat, a xanthine oxidase inhibitor.

24 Dec 2015

Novel antibody improves glucose regulation and reduces fatty liver in obese mice

A new study by researchers from Harvard T.H. Chan School of Public Health and colleagues describes the pre-clinical development of a therapeutic that could potentially be used to treat type 2 diabetes, fatty liver disease, and other metabolic diseases.

24 Dec 2015

Selexipag holds promise for treatment of pulmonary hypertension

Living with pulmonary arterial hypertension is challenging, but the chore of treating the rare heart disease may change following promising clinical trial data to be published in the Dec. 24 issue of the New England Journal of Medicine.

24 Dec 2015

Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

Sanofi announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, which if approved would be administered as a single daily injection for the treatment of adults with type 2 diabetes.

24 Dec 2015

NEJM publishes results of Cosentyx Phase III studies in ankylosing spondylitis

Novartis announced today that the results of the MEASURE 1 and MEASURE 2 Phase III studies for Cosentyx® (secukinumab) in ankylosing spondylitis (AS) were published in The New England Journal of Medicine (NEJM). These pivotal studies demonstrated significant clinical improvements with Cosentyx versus placebo in reducing the signs and symptoms of active AS – a long-term, painful and debilitating inflammation of the spine.

24 Dec 2015

Encouraging results from cannabidiol trial for treatment-resistant epilepsy

Cannabidiol (CBD), a medical marijuana derivative, was effective in reducing seizure frequency and well-tolerated and safe for most children and young adults enrolled in a year-long study led by epilepsy specialists at NYU Langone Medical Center.

24 Dec 2015

Single VRC01 antibody infusion could suppress HIV level in people not taking ART

A single infusion of a powerful antibody called VRC01 can suppress the level of HIV in the blood of infected people who are not taking antiretroviral therapy (ART), scientists at the National Institutes of Health report in a paper published today.

24 Dec 2015

Immunogeneticist helps monitor immune responses in VRC01 phase 1 trial in HIV-infected individuals

Janardan Pandey, Ph.D., an immunogeneticist specializing in immunoglobulin GM genes at the Medical University of South Carolina, helped monitor for immune responses that could limit the effectiveness of the broadly neutralizing antibody VRC01 in a phase 1 trial of that antibody in HIV-infected individuals led by a team at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

24 Dec 2015

EMA CHMP considers AcelRx's ARX-04 for acute pain treatment for centralized review

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, reported that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has confirmed that a Marketing Authorization Application (MAA) for ARX-04 may be submitted in the European Union (EU) under the Agency's centralized procedure.

24 Dec 2015

Cardiome files NDS with Health Canada's TPD for approval of intravenous vernakalant

Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced the filing of a New Drug Submission (NDS) with Health Canada's Therapeutic Products Directorate (TPD) seeking Canadian approval of intravenous vernakalant for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults with AF for up to 7 days.

23 Dec 2015

TIGER-X study reviews efficacy of rociletinib therapy in patients with EGFR mutant-positive NSCLC

Oncology & Hematology Review, the peer-reviewed journal, has published a review highlighting recent data around rociletinib, an investigational therapy in patients with previously treated EGFR mutant-positive non-small cell lung cancer.

23 Dec 2015

Study shows more patients with advanced NSCLC may benefit from pembrolizumab

More patients with advanced non-small-cell lung cancer (NSCLC) could benefit from pembrolizumab, says Professor Roy Herbst, Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven, presenting promising results from the pivotal phase 2/3 KEYNOTE-010 trial at the first ESMO Asia Congress in Singapore), in conjunction with a publication in The Lancet.

22 Dec 2015

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)].

22 Dec 2015

Patients with EGFR-mutated lung cancer benefit more from afatinib as first-line treatment

Patients with EGFR-activating mutations in advanced lung cancer seem to benefit more from afatinib than gefitinib as first-line treatment, researchers report at the first ESMO Asia 2015 Congress in Singapore.

21 Dec 2015

Alexza reports interim results from AZ-002 Phase 2a study in epilepsy patients

Alexza Pharmaceuticals, Inc. today announced interim results of its Phase 2a study of AZ-002 (Staccato alprazolam) in epilepsy patients. AZ-002 produced a dose-related decrease in mean Standardized Photosensivity Range (SPR), the primary endpoint in the study.

21 Dec 2015

Nuvo Research announces topline results from WF10 Phase 2 trial for treatment of allergic rhinitis

Nuvo Research Inc., a life sciences company with growing revenues and a diverse portfolio of topical products, today announced the results of its investigational Phase 2 clinical trial of WF10 (Trial) for the treatment of allergic rhinitis.

21 Dec 2015

Drug Trial News

Discovery Laboratories initiates AEROSURF phase 2b clinical trial in premature infants with RDS

Myostatin antibody shows promise in treating age-related decline in muscle mass and power

Rich Pharmaceuticals obtains FDA approval to begin Phase 1/2 study in AML and MDS patients

Azithromycin remains effective in treatment of urogenital chlamydia, confirms UAB study

Positive interim results from TWIB's AC-201 CR Phase 2 study for hyperuricemia and gout

Novel antibody improves glucose regulation and reduces fatty liver in obese mice

Selexipag holds promise for treatment of pulmonary hypertension

Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

NEJM publishes results of Cosentyx Phase III studies in ankylosing spondylitis

Encouraging results from cannabidiol trial for treatment-resistant epilepsy

Single VRC01 antibody infusion could suppress HIV level in people not taking ART

Immunogeneticist helps monitor immune responses in VRC01 phase 1 trial in HIV-infected individuals

EMA CHMP considers AcelRx's ARX-04 for acute pain treatment for centralized review

Cardiome files NDS with Health Canada's TPD for approval of intravenous vernakalant

TIGER-X study reviews efficacy of rociletinib therapy in patients with EGFR mutant-positive NSCLC

Study shows more patients with advanced NSCLC may benefit from pembrolizumab

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

Patients with EGFR-mutated lung cancer benefit more from afatinib as first-line treatment

Alexza reports interim results from AZ-002 Phase 2a study in epilepsy patients

Nuvo Research announces topline results from WF10 Phase 2 trial for treatment of allergic rhinitis

Redefining control and consistency in anaerobic microbiome workflows

AI in Healthcare: How generative tools are transforming clinical practice

The future of automation: Machine learning–driven hepatocyte and organoid counting

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