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Daily news and top headlines for drug research professionals

FDA Grants Mirati’s Mocetinostat Orphan Drug Designation

June 18, 2014 1:29 pm | News | Comments

Mirati Therapeutics Inc. announced that mocetinostat, the company's spectrum selective HDAC inhibitor, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration as a treatment for myelodysplastic syndrome (MDS). Read more...

Inovio Broadens Its UPenn Intellectual Property Portfolio

June 18, 2014 1:24 pm | News | Comments

Inovio Pharmaceuticals Inc. has expanded its existing license agreement with the University of Pennsylvania, adding exclusive worldwide rights to technology and intellectual property for novel synthetic therapies against cancer, infectious diseases and new immune activators. Read more...

Metformin Modulates Gut Microbiome, Improves Glycemic Control

June 18, 2014 1:17 pm | News | Comments

MicroBiome Therapeutics LLC reported that a recently published scientific study shows that the diabetes drug, metformin, alters the bacterial populations in the gut in favor of a bacterial species that exerts specific cellular and immunological effects, resulting in improved glycemic control. Read more...

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Merck Stops Development of Endocyte Cancer Drug

June 18, 2014 1:09 pm | News | Comments

Biotech drug maker Endocyte said Tuesday it has regained rights to an experimental cancer drug from Merck & Co., after the treatment failed in a key study last month, and Merck decided to discontinue development of vintafolide. Read more...

Vaccine ‘Reprograms’ Pancreatic Cancers

June 18, 2014 12:47 pm | News | Comments

Researchers at the Johns Hopkins Kimmel Cancer Center have developed and tested a vaccine that triggered the growth of immune cell nodules within pancreatic tumors, essentially reprogramming these intractable cancers and potentially making them vulnerable to immune-based therapies. Read more...

3SBio Licenses Novel Gout Drug to Selecta

June 18, 2014 10:20 am | News | Comments

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, announced it has entered into an exclusive license with Selecta Biosciences for pegsiticase (Uricase PEG-20), a pegylated recombinant uricase from candida utilis. Read more...

AmVac Initiates Phase 3 Trial of Vaginosis Vaccine

June 18, 2014 10:14 am | News | Comments

Swiss-based AmVac AG announced the initiation of a Phase 3 study with AmVac’s lead vaccine Gynevac in bacterial vaginosis, which aims to confirm the safety and efficacy of a new generation of the vaccine produced in accordance to the current GMP standards. Read more...

Psioxus Kicks Off Oncolytic Vaccine Study in Ovarian Cancer

June 18, 2014 10:09 am | News | Comments

PsiOxus Therapeutics Ltd., an award-winning biotechnology company developing innovative new treatments for cancer, announced the first dosing of a patient in the OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) study. Read more...

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Single Dose Reverses Autism-Like Symptoms in Mice

June 18, 2014 9:57 am | News | Comments

In a further test of a novel theory that suggests autism is the consequence of abnormal cell communication, researchers at the University of California, San Diego School of Medicine report that an almost century-old drug approved for treating sleeping sickness also restores normal cellular signaling in a mouse model of autism. Read more...

Janssen Lands Worldwide License with Vertex for Flu Drug

June 18, 2014 9:47 am | News | Comments

Janssen Pharmaceuticals Inc. announced that it has entered into an exclusive license agreement with Vertex Pharmaceuticals for the worldwide development, manufacturing and commercialization of VX-787, a novel medicine in Phase 2 development for the treatment of influenza A. Read more...

Convergence's Orphan Drug Reduces Pain in Trigeminal Neuralgia

June 17, 2014 3:21 pm | News | Comments

Convergence Pharmaceuticals Holdings Ltd., the company focused on the development of novel and high value analgesic medicines for the treatment of chronic pain via a genetically defined approach, announced positive data from the Phase 2 clinical trial of novel sodium channel blocker in patients with trigeminal neuralgia. Read more...

Sanofi Posts Positive Phase 3 Results for Novel Basal Insulin

June 17, 2014 3:01 pm | News | Comments

Sanofi announced full results from EDITION JP I and EDITION JP II that showed Toujeo achieved similar blood sugar control with fewer people with type 1 and type 2 diabetes experiencing night-time low blood sugar events compared with Lantus. Read more...

Eisai’s Antiepileptic Drug Meets Primary Endpoint

June 17, 2014 2:54 pm | News | Comments

Eisai Inc. announced that a Phase 3 clinical trial (study 332) of its in-house-discovered AMPA receptor antagonist perampanel has met its primary endpoint in patients with primary generalized tonic-clonic (PGTC) seizures, a severe form of seizures. Read more...

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Pfizer Submits BLA for Meningococcal B Vaccine

June 17, 2014 11:01 am | News | Comments

Pfizer Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25 year olds. Read more...

Lilly Details Diabetes Drugs' Phase 3 Results

June 17, 2014 10:48 am | News | Comments

Eli Lilly and Co. released detailed results from two AWARD trials that showed treatment with once-weekly dulaglutide 1.5 mg resulted in superior reductions in HbA1c from baseline compared to insulin glargine, with a lower risk for hypoglycemia. Read more...

Merck, Ono Agree to Terminate License Agreement

June 17, 2014 10:33 am | News | Comments

Merck announced that it has reached a mutual agreement with Ono Pharmaceutical Co. Ltd., Osaka, Japan, to terminate the license agreement on ceralifimod (ONO-4641) because it does not meet Merck’s threshold for continued investment. Read more...

Avion Gets Positive FDA Feedback Women's Health NDAs

June 16, 2014 2:28 pm | News | Comments

Avion Pharmaceuticals LLC, a specialty pharmaceutical company, announced positive feedback on two New Drug Applications with projected approvals of late 2016 and early 2017 and will be moving into Phase 2/3 on one NDA Program, and into Phase 2 on the other. Read more...

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...

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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