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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

Mirati announces initiation of glesatinib Phase 2 clinical trial in NSCLC patients

Mirati Therapeutics, Inc. today announced that the Phase 2 clinical trial of glesatinib (MGCD265) has commenced. The Company also announced that "glesatinib" is the proposed generic name for MGCD265.

21 Dec 2015

SciClone plans to pursue development of SGX942 in the Greater China market

SciClone Pharmaceuticals, Inc. today announced plans to pursue development and registration of SGX942 in the Greater China market, for the treatment of oral mucositis.

21 Dec 2015

Regulus begins RG-125(AZD4076) Phase I study for treatment of NASH in patients with type 2 diabetes/pre-diabetes

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-125(AZD4076), by its collaboration partner AstraZeneca.

21 Dec 2015

GeNeuro initiates GNbAC1 Phase IIb study in Relapsing-Remitting Multiple Sclerosis

GeNeuro SA, a pioneer of new therapies for neurology and autoimmune disorders, announced today that it has initiated its planned Phase IIb study “CHANGE-MS” (Clinical trial assessing the HERV-W Env ANtagonist GNbAC1 for Efficacy in Multiple Sclerosis) with its lead antibody GNbAC1 in Relapsing-Remitting Multiple Sclerosis (RRMS).

21 Dec 2015

Adaptimmune begins Phase I/II study of affinity enhanced T-cell therapy targeting MAGE-A10 in NSCLC patients

Adaptimmune Therapeutics plc, a leader in the use of TCR engineered T-cell therapy to treat cancer, today announced that it has initiated a Phase I/II study of its affinity enhanced T-cell therapy targeting the MAGE-A10 cancer antigen in patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC), the most prevalent type of lung cancer representing approximately 85 percent of lung cancers.

21 Dec 2015

Combination therapy can help overcome endocrine resistance in women with advanced breast cancer

Data collected in Japanese and Korean patients included in the global PALOMA3 trial provides evidence that combining palbociclib with fulvestrant is an effective strategy to overcome endocrine resistance in women with hormone receptor positive (HR+), HER2 negative (HER2-) advanced breast cancer.

20 Dec 2015

DS Biopharma reports completion of DS102 Phase I trial for treatment of fatty liver disorders

DS Biopharma, a privately held biopharmaceutical company, today announced the successful completion of a Phase I trial with an oral formulation of the active pharmaceutical ingredient DS102 (15-HEPE) which is being explored for the treatment of fatty liver disorders, such as non-alcoholic steatohepatitis (NASH) and pulmonary disorders, such as idiopathic pulmonary fibrosis (IPF).

18 Dec 2015

Drug Trial News

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

Mirati announces initiation of glesatinib Phase 2 clinical trial in NSCLC patients

SciClone plans to pursue development of SGX942 in the Greater China market

Regulus begins RG-125(AZD4076) Phase I study for treatment of NASH in patients with type 2 diabetes/pre-diabetes

GeNeuro initiates GNbAC1 Phase IIb study in Relapsing-Remitting Multiple Sclerosis

Adaptimmune begins Phase I/II study of affinity enhanced T-cell therapy targeting MAGE-A10 in NSCLC patients

Combination therapy can help overcome endocrine resistance in women with advanced breast cancer

DS Biopharma reports completion of DS102 Phase I trial for treatment of fatty liver disorders

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