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Daily news and top headlines for drug research professionals

Combo Treatment Ups PFS in Advanced Melanoma Patients

September 29, 2014 3:07 pm | News | Comments

Shares of Exelixis jumped Monday before markets opened and after the drugmaker said its treatment for a deadly form of skin cancer fared better than another drug in a late-stage clinical study. Read more...

Bristol-Myers Squibb Gets Positive Results for Nivoluma

September 29, 2014 2:58 pm | News | Comments

Bristol-Myers Squibb Co. announced positive results from CheckMate-037, a Phase 3 randomized, controlled open-label study of Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, versus investigator’s choice chemotherapy (ICC) in patients with advanced melanoma. Read more...

Cancer Research UK Increases Drug Development Investment

September 29, 2014 10:21 am | News | Comments

Cancer Research UK is to increase investment by nearly 50% over the next five years in its Drug Development Office, which is also changing its name to the Center for Drug Development (CDD). Read more...              

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Genentech’s Perjeta Regimen Extended Lives

September 29, 2014 9:59 am | News | Comments

Genentech announced final survival results from the Phase 3 Cleopatra study, which showed that adding Perjeta to Herceptin and docetaxel chemotherapy extended the lives of people with previously untreated HER2-positive metastatic breast cancer by 15.7 months compared to Herceptin and chemotherapy. Read more...

MicroBiome Therapeutics' Drug May Limit Metformin Side Effects

September 26, 2014 3:47 pm | News | Comments

MicroBiome Therapeutics reported positive topline results from a proof-of-concept study testing whether its investigational drug, NM 505, can improve the tolerability of metformin, the first-line therapy for Type 2 diabetes worldwide. Read more...

Bausch + Lomb Receives Successful Results from Phase 3 Study

September 26, 2014 10:59 am | News | Comments

Bausch + Lomb announced that its next generation sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo (vehicle gel) in eliminating inflammation and pain following cataract surgery by study day eight, the primary endpoints in the first Phase 3 study. Read more...

Gilead Gets Positive Opinion for HCV Tablet

September 26, 2014 10:48 am | News | Comments

Gilead Sciences Inc. announced that the CHMP, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorization Application (MAA) for Harvoni, an investigational once-daily tablet combining the NS5A inhibitor (LDV) 90 mg and the nucleotide analog polymerase inhibitor (SOF) 400 mg for the treatment of HCV infection in adults. Read more...

MabVax Neuroblastoma Vaccine Gets Orphan Drug Designation

September 25, 2014 2:51 pm | News | Comments

MabVax Therapeutics Holdings Inc. announced that the FDA has granted orphan drug designation to the company's vaccine intended for the treatment of the childhood cancer neuroblastoma. Read more...               

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Boehringer Ingelheim Announces FDA Approval of COPD Drug

September 25, 2014 1:31 pm | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the FDA approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Read more...

Novartis Psoriatic Arthritis Drug Hits Endpoints in Two Phase 3 Trials

September 25, 2014 10:06 am | News | Comments

Novartis announced that two pivotal Phase 3 studies (FUTURE 1 and FUTURE 2) of AIN457 (secukinumab) in psoriatic arthritis (PsA) met primary and key secondary endpoints. Read more...

Gilead's Investigational HIV Drug Meets Trial Goals

September 24, 2014 3:17 pm | News | Comments

Gilead Sciences Inc. announced that two Phase 3 clinical trials evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide for the treatment of HIV-1 infection in treatment-naïve adults met their primary objectives. Read more...

Inovio Pharma Plans Humans Trials of Ebola Vaccine

September 24, 2014 2:45 pm | News | Comments

Inovio Pharmaceuticals plans to initiate human testing of a DNA-based vaccine for the Ebola virus in the first half of 2015. Read more...                                

New Awards Apply Sex, Gender Lens to NIH-Funded Research

September 23, 2014 10:57 am | News | Comments

The NIH has invested $10.1 million in supplemental funding to bolster the research of 82 grantees to explore the effects of sex in preclinical and clinical studies. Read more...                     

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Ebola Drug Trials to be Fast-Tracked in West Africa

September 23, 2014 10:48 am | News | Comments

Potential new treatments for Ebola are to be tested in West Africa for the first time as part of an international initiative to fast-track trials of the most promising drugs against the disease that has already led to over 2,600 deaths. Read more...

Tekmira’s Ebola Drug Gets Regulatory Framework

September 22, 2014 2:56 pm | News | Comments

Tekmira Pharmaceuticals Corp. announced that the FDA has authorized Tekmira to provide TKM-Ebola for treatment under expanded access protocols to subjects with confirmed or suspected Ebola virus infections. Read more...          

Lilly's Combo Treatment Improves OS in Gastric Cancer Patients

September 18, 2014 3:58 pm | News | Comments

Eli Lilly and Co. announced that results of the global Phase 3 trial of ramucirumab (Cyramza) in combination with paclitaxel in patients with advanced gastric (stomach) cancer or gastroesophageal junction (GEJ) adenocarcinoma were published in a sholarly journal. Read more...

Ryzodeg Offers Glycemic Control With Fewer Injections

September 18, 2014 9:17 am | News | Comments

Data presented by Novo Nordisk show that Ryzodeg (insulin degludec/insulin aspart), administered twice daily, provides successful glycemic control with fewer injections than a basal-bolus regimen. Read more...            

Gilead Releases Phase 2 Pancreatic Cancer Data

September 17, 2014 3:28 pm | News | Comments

Gilead Sciences Inc. announced results from a Phase 2 study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2 (LOXL2), in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer. Read more...

1st Volunteer Gets Experimental Ebola Vaccine

September 17, 2014 12:46 pm | News | Comments

British scientists say a former nurse has become the first person in the country to receive an experimental Ebola vaccine in an early trial to test its safety. Read more...                       

Merck Diabetes Drug Hits Endpoints in Japanese Study

September 17, 2014 10:44 am | News | Comments

Merck announced the presentation of the first data from the Phase 3 clinical development program for omarigliptin, Merck’s investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes. Read more...         

Glenmark's TRPA1 Antagonist Excels in Phase 2a

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

Glenmark Pharmaceuticals announced that its first-in-class Transient Receptor Potential Ankyrin 1 antagonist, GRC 17536, has shown positive data in a Phase 2a study conducted on 138 patients in Europe and India. Read more...       

TapImmune Releases Interim Data on Phase 1 Cancer Trial

September 16, 2014 3:39 pm | News | Comments

TapImmune Inc. reported that analysis of the interim data from the first 13 patients in a Phase 1 clinical trial show that each of the patients treated have raised specific T-cell immune responses against a set of five naturally processed folate receptor alpha Class II antigenic epitopes. Read more...

Amarin Committed to Completing Cardiovascular Outcomes Study

September 16, 2014 3:34 pm | News | Comments

Amarin Corp. announced its continued commitment to completing the ongoing REDUCE-IT (Reduction of Cardiovascular Events with EPA-Intervention Trial) cardiovascular outcomes study. Read more...                 

Mylan to Begin Phase 3 Trials on Key Generics

September 16, 2014 3:28 pm | News | Comments

Mylan Inc. announced it is initiating Phase 3 clinical trials for its generic version of GlaxoSmithKline's Advair Diskus and its insulin analog to Sanofi's Lantus.  Read more...                   

Bayer, Orion Initiate Phase 3 Prostate Cancer Trial

September 16, 2014 10:26 am | News | Comments

Bayer HealthCare and Orion Corp. have begun to enroll patients in a Phase 3 trial with ODM-201, an investigational novel oral androgen receptor (AR) inhibitor in clinical development for the treatment of patients with prostate cancer. Read more...

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