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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

Kitov announces more data from Phase III trial on the favorable blood pressure effects of KIT-302

Kitov Pharmaceuticals, an innovative biopharmaceutical company focused on late-stage drug development, today announced more data from its successfully concluded Phase III trial for its lead drug candidate, KIT-302. Data showed the favorable blood pressure effects of KIT-302 were present in all blood pressure variables measured in the study.

18 Dec 2015

Chi-Med announces initiation of Phase III sulfatinib registration trial in patients with NETs in China

Hutchison China MediTech Limited today announces that Hutchison MediPharma Limited, its drug R&D subsidiary, has initiated SANET-ep, a Phase III sulfatinib (HMPL-012) registration trial in China in patients with extra-pancreatic neuroendocrine tumors ("NETs"), which are all non-pancreatic NETs, including, for example, NETs originating in the lymph, lung and across the gastrointestinal tract.

18 Dec 2015

Novel strategies on the way for difficult-to-treat head and neck cancer

Novel strategies are on the way for difficult-to-treat and advanced head and neck cancer, the most heterogeneous group of malignancies which are generally associated with poor survival, and encouraging results have been presented at the first ESMO Asia 2015 Congress in Singapore.

17 Dec 2015

Soligenix reports positive results from SGX942 Phase 2 trial in patients with head and neck cancer

Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive results in its Phase 2 clinical trial, in which SGX942, a first-in-class Innate Defense Regulator (IDR), at a dose of 1.5 mg/kg, successfully reduced the median duration of severe oral mucositis by 50% in all patients and by 67% in patients receiving the most aggressive chemoradiation therapy (CRT) for treatment of their head and neck cancer.

16 Dec 2015

Array BioPharma reports top-line results from binimetinib Phase 3 trial in patients with NRAS-mutant melanoma

Array BioPharma today reported top-line results from the ongoing Phase 3 clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, known as the NEMO trial. The study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment.

16 Dec 2015

Researchers test new concept in type 2 diabetes patients going into remission

Remission is well-known as the goal in cancer treatment but scientists are discovering it's also an exciting possibility for those with type 2 diabetes.

16 Dec 2015

Drug Trial News

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

Kitov announces more data from Phase III trial on the favorable blood pressure effects of KIT-302

Chi-Med announces initiation of Phase III sulfatinib registration trial in patients with NETs in China

Novel strategies on the way for difficult-to-treat head and neck cancer

Soligenix reports positive results from SGX942 Phase 2 trial in patients with head and neck cancer

Array BioPharma reports top-line results from binimetinib Phase 3 trial in patients with NRAS-mutant melanoma

Researchers test new concept in type 2 diabetes patients going into remission

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