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Daily news and top headlines for drug research professionals

Advaxis Studies Higher Dose, Repeat Cycles of Cervical Cancer Drug

June 16, 2014 2:22 pm | News | Comments

Advaxis Inc., a clinical-stage biotechnology company developing cancer immunotherapies, announced that the Georgia Regents University Cancer Center has received Institutional Review Board approval to initiate a Phase 1/2 trial evaluating higher doses and repeat cycles of ADXS-HPV in patients with recurrent cervical cancer. Read more...

Mast Therapeutics Kicks Off Sickle Cell Drug Sub-Study

June 16, 2014 2:18 pm | News | Comments

Mast Therapeutics Inc. announced that, in line with prior guidance, it has initiated patient enrollment in a sub-study within EPIC, its pivotal Phase 3 study of MST-188 in sickle cell disease, to investigate and quantify the effect of MST-188 on tissue oxygenation. Read more...

Boston Biomedical Sums Up Cancer Stem Cell Inhibitor Data

June 16, 2014 2:12 pm | News | Comments

Boston Biomedical, a company focused on the research and development of novel cancer therapeutics targeting cancer stem cells (CSC), provided a summary of the clinical data presented at the 2014 American Society of Clinical Oncology (ASCO) 50th annual meeting, held in Chicago, Ill. Read more...

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Lilly’s Basal Insulin Boasts Novel MOA

June 16, 2014 1:57 pm | News | Comments

Eli Lilly and Co. announced new data regarding the mechanism of action of basal insulin peglispro showing that it has less activity in peripheral tissues, such as muscle and fat, providing further evidence that it works in a fundamentally different way than insulin glargine. Read more...

Analysis of Celgene Cancer Drug Trial Shows Increased OS Data

June 16, 2014 10:55 am | News | Comments

Celgene International Sàrl recently presented a retrospective analysis of MM-003, the company’s Phase 3 study of pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone in patients with refractory multiple myeloma who have failed therapy with both bortezomib and lenalidomide. Read more...

Gilead Hep C Combo Achieves 100% SVR12 in Japan

June 16, 2014 10:33 am | News | Comments

Gilead Sciences Inc. announced topline results from a Phase 3 clinical trial in Japan evaluating the investigational combination of ledipasvir (LDV) and sofosbuvir (SOF), with and without ribavirin, for the treatment of genotype 1 chronic HCV infection. Read more...

Novo Nordisk Diabetes Drug Excels in Phase 3

June 16, 2014 10:13 am | News | Comments

Data from a new Phase 3 study demonstrated that Novo Nordisk's once-daily Victoza (liraglutide) provided greater glycemic control versus placebo with no worsening of renal function in adults with type 2 diabetes and moderate renal impairment. Read more...

Neurogenic Drug Improves Depression in Small Trial

June 16, 2014 9:54 am | by Cynthia Fox, Science Editor | Articles | Comments

The first small molecule drug discovered with the aid of stem cells - NSI-189, a benzylpiperizine-aminiopyridine - has significantly affected major depressive disorder (MDD) in a small group of patients, Harvard neurologists report this week. Read more...

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OncoMed Halts Wnt Pathway Inhibitor Trials

June 13, 2014 2:43 pm | News | Comments

OncoMed Pharmaceuticals Inc. announced that the company has voluntarily halted patient enrollment and dosing in its ongoing Phase 1 clinical trials of its two Wnt pathway inhibitor programs, vantictumab (anti-Fzd7, OMP-18R5) and Fzd8-Fc (OMP-54F28). Read more...

GSK cITP Trial Hits Key Endpoints in Phase 3

June 13, 2014 10:53 am | News | Comments

GlaxoSmithKline announced the results from the Phase 3 PETIT2 study evaluating the efficacy of eltrombopag vs. placebo in pediatric patients with chronic immune (idiopathic) thrombocytopenic purpura (cITP). Read more...         

Committee Recommends Nixing Cardiovascular Outcomes Trial for PAMORA Drugs

June 13, 2014 10:40 am | News | Comments

AstraZeneca announced that the majority of FDA Anesthetic and Analgesic Drug Products Advisory Committee members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs, which includes AstraZeneca's Movantik. Read more...

FDA Lifts Partial Hold on Geron's Myelofibrosis Trial

June 13, 2014 10:28 am | News | Comments

Geron Corp. announced that the FDA has removed the partial clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST). Read more...                    

Ruthigen Gets the ‘Green Light' on Anti-infective Studies

June 12, 2014 1:22 pm | News | Comments

Ruthigen Inc., a biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, is pleased to announce that the FDA has cleared the company's IND application without a clinical hold to begin human clinical testing of RUT58-60. Read more...

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Early DCVax Data Are Increasingly Encouraging in Cancer

June 12, 2014 1:06 pm | News | Comments

Northwest Biotherapeutics announced that, in the ongoing Phase 1/2 clinical trial of DCVax-Direct for all types of inoperable solid tumors, all nine out of nine patients who have received four of the six planned injections are showing tumor cell death, tumor shrinkage, substantial immune cell accumulation in their tumors and/or stabilization of their advanced cancer. Read more...

Oncobiologics Kicks Off Trial of Humira Biosimilar

June 12, 2014 12:59 pm | News | Comments

Oncobiologics Inc. announced that it has received approval to initiate a Phase 1 clinical trial in Europe - expected to be completed before the end of 2014 - for its first biosimilar molecule, ONS-3010, a highly biosimilar version of the marketed drug, Humira. Read more...

Inovio Calls Foul on Immunotherapy Conjecture

June 12, 2014 12:38 pm | News | Comments

Inovio Pharmaceuticals Inc. wishes to clarify that a third party article published on June 10, 2014, was misrepresentative of facts, as it does not reflect the progress, status, and potential of Inovio's active immune therapy technology and products and is rife with false and misleading conjecture. Read more...

Brodalumab Treatment Improves Clinical Signs, Symptoms in Phase 2

June 12, 2014 10:45 am | News | Comments

Amgen and AstraZeneca announced that results from a Phase 2 study evaluating brodalumab in 168 patients with psoriatic arthritis showed that treatment with brodalumab significantly improved signs and clinical symptoms associated with the disease. Read more...

Sanofi-Regeneron RA Drug Increases Clinical Response Rates

June 12, 2014 10:10 am | News | Comments

Sanofi and Regeneron presented positive results from a Phase 3 trial of investigational drug sarilumab in rheumatoid arthritis (RA) patients who were inadequate responders to methotrexate (MTX) therapy. Read more...          

Shire Agrees to Conduct Trials of Vyvanse in ADHD Kids

June 12, 2014 9:48 am | News | Comments

Shire announced that it has agreed to a request by the FDA to conduct pediatric clinical studies to investigate the potential use of Vyvanse for the treatment of ADHD in preschool-age children, ages 4 to 5. Read more...         

BMS Drug Helps to Lift RA Remission Rates

June 11, 2014 2:22 pm | News | Comments

Bristol-Myers Squibb announced its first release of new data from a Phase 3b RA trial showing that the T-cell co-stimulation modulator, Orencia (abatacept), in combination with methotrexate (MTX) achieved significantly higher rates of DAS-defined remission at 12 months than treatment with standard of care agent MTX. Read more...

Lilly Liver Cancer Drug Misses Primary Endpoint

June 11, 2014 11:58 am | News | Comments

Eli Lilly and Co. announced that the Phase 3 REACH trial of Cyramza (ramucirumab) in patients with hepatocellular carcinoma, also known as liver cancer, did not meet its primary endpoint. Read more...               

Otsuka Continues Tolvaptan Program After FDA Negotiations

June 11, 2014 10:43 am | News | Comments

Otsuka announced that patient enrollment has begun for a new Phase 3b study of tolvaptan for adult patients with autosomal dominant polycystic kidney disease. The company reached an agreement with the FDA on a Special Protocol Assessment for the design and planned analysis of this trial. Read more...

Ketamine May be a ‘Game Changer’ in Suicide Prevention

June 11, 2014 10:30 am | News | Comments

A drug traditionally used as an anesthetic, and sometimes used recreationally, could be effective in preventing suicide and lifting the mood of severely depressed patients, according to a new study. Read more...            

GSK, Theravance Release Phase 3 COPD Results

June 11, 2014 10:13 am | News | Comments

GSK and Theravance announced positive results from two Phase 3 studies, which showed that patients with COPD who received umeclidinium or umeclidinium 125mcg in addition to fluticasone furoate/vilanterol (FF/VI]), achieved an additional improvement in lung function (FEV1) compared to patients receiving FF/VI plus placebo. Read more...

Inovio Targets Rapidly Increasing Cancer in Men

June 10, 2014 3:17 pm | News | Comments

Inovio Pharmaceuticals Inc. announced it has initiated a Phase 1/2a clinical trial to evaluate safety, immunogenicity and clinical responses of its immunotherapy product, INO-3112, in treating human papillomavirus (HPV)-associated head and neck cancer. Read more...

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