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Daily news and top headlines for drug research professionals

Artes, Burnet Institute Partner on Malaria Vaccine

July 29, 2014 11:13 am | by Catherine Somerville | News | Comments

Artes Biotechnology and Burnet Institute have joined forces to develop a new type of malaria vaccine in a project funded by the PATH Malaria Vaccine Initiative (MVI), which will produce purified vaccine antigens as virus-like particles, a type of nano-particle, for testing in laboratory studies. Read more...

European Commission Approves Leukemia Drug

July 29, 2014 11:04 am | News | Comments

Roche announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Read more...

Merck Serono Kicks Off Study of Merkel Cell Carcinoma Drug

July 29, 2014 10:59 am | News | Comments

Merck Serono, the biopharmaceutical division of Merck, announced the initiation of an international Phase 2 study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1). Read more...

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China to Put GSK Investigators on “Public Trial”

July 29, 2014 10:54 am | News | Comments

A Shanghai court said American and British investigators who worked for drug maker GlaxoSmithKline will stand trial - which now will be public - Aug. 8 on charges of illegally obtaining information on Chinese citizens. Read more...    

Biologists Think Stem Cells May “Talk” to Each Other

July 29, 2014 10:47 am | News | Comments

Biologists at the University of Sheffield’s Centre for Stem Cell Biology led by Prof. Peter Andrews and engineers in the Complex Systems and Signal Processing Group led by Prof. Daniel Coca have completed a landmark study of human pluripotent stem cells. Read more...

Merck Profit More Than Doubles in Q2

July 29, 2014 8:28 am | by Linda A. Johnson | News | Comments

A big one-time gain and a tax benefit helped drugmaker Merck & Co. more than double its second-quarter profit, raise the lower end of its profit forecast and easily top analysts' expectations. Read more...           

FDA Rejects Zalviso Pain Treatment System

July 28, 2014 12:45 pm | News | Comments

AcelRx Pharmaceuticals Inc. announced that the FDA has issued a Complete Response Letter (CRL) for the company's NDA for Zalviso. The CRL contains requests for additional information on the system to ensure proper use of the device. Read more... 

AstraZeneca, QIAGEN Collaborate on Iressa Diagnostic Test

July 28, 2014 12:38 pm | News | Comments

AstraZeneca announced that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer patients who are suitable for treatment with Iressa. Read more...    

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HIV Inhibitor May Also Block Herpes Infection

July 28, 2014 12:19 pm | News | Comments

Creating a successful vaccine against two members of the herpes virus family, the sexually transmitted herpes simplex virus 1 (HSV-1) and 2 (HSV-2), has proven to be challenging. But now, a clinical trial, based on an HSV-2 vaccine, is being conducted. Read more...

MedImmune Fights Pediatricians' New Advice

July 28, 2014 12:13 pm | by Lindsey Tanner, AP Medical Writer | News | Comments

A costly drug given mostly to premature babies is at the center of a clash between the manufacturer and the nation's leading pediatrician's group, which recommends scaling back use of the medicine. Read more...            

FDA Clears IND for Lorus Blood Cancer Drug

July 28, 2014 10:53 am | News | Comments

Lorus Therapeutics Inc. announced that the FDA completed its review and cleared the company's IND application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukemia, high-risk myelodysplastic syndromes, lymphomas and multiple myeloma. Read more...

Veloxis Gets EU Marketing Authorization for Transplant Drug

July 28, 2014 10:47 am | News | Comments

Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. announced that the European Commission (EC) has granted marketing authorization for Envarsus for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU). Read more...

AstraZeneca, Roche Collaborate on Companion Diagnostic Test

July 28, 2014 10:41 am | News | Comments

AstraZeneca announced it has entered into collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small-cell lung cancer (NSCLC). Read more...

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COSMOS Results Published on World Hepatitis Day

July 28, 2014 10:35 am | News | Comments

Medivir AB announced that results from the phase 2 COSMOS clinical study were published in The Lancet, demonstrating that 92% of genotype 1 chronic hepatitis C virus adult patients treated with simeprevir in combination with sofosbuvir achieved sustained virologic response 12 weeks after the end of treatment. Read more...

Emulate to Commercialize Organs-on-Chips Platform

July 28, 2014 10:25 am | News | Comments

Emulate Inc. announced the company’s launch with a $12 million Series A financing to commercialize a first-in-kind, automated ‘Organs-on-Chips’ platform that mimics human physiology and diseases, while permitting real-time elucidation of molecular mechanisms of action and toxicity. Read more...

Liberia’s President Tries to Contain Ebola Outbreak

July 28, 2014 10:17 am | by Jonathan Paye-Layleh, Associated Press | News | Comments

Liberia's president has closed all but three land border crossings, restricted public gatherings and quarantined communities heavily affected by the Ebola outbreak in the West African nation, which has killed 129 people in the country and more than 670 across the region. Read more...

Panel Backs Extended Use of Allergan's DME Treatment

July 25, 2014 2:53 pm | News | Comments

Allergan announced that the European Union's Committee for Medicinal Products for Human Use has recommended extending the Marketing Authorization for Ozurdex to treat adult patients with vision loss due to diabetic macular edema. Read more...   

SRI Snags NIH Contract for HIV, AIDS Therapies

July 25, 2014 2:47 pm | News | Comments

SRI International has been awarded a new $49 million, seven-year contract with the NIAID, part of the NIH, to conduct preclinical development of potential therapies for HIV infection and AIDS. Read more...              

EPFL, Nearmedic Pharma Partner to Fight Tuberculosis

July 25, 2014 2:42 pm | News | Comments

The pharmaceutical company Nearmedic is collaborating with EPFL to participate in the development of a treatment against tuberculosis. Read more...                             

More U.S. Girls Now Getting Cervical Cancer Vaccine

July 25, 2014 2:20 pm | News | Comments

More teen girls are getting a controversial cervical cancer vaccine but the increase isn't much of a bump, the government reported Thursday. Read more...                            

Humira Lifts AbbVie 2.8% in Q2

July 25, 2014 12:00 pm | by The Associated Press | News | Comments

Drugmaker AbbVie Inc.'s second-quarter profit increased nearly 3 percent and beat analysts' expectations, as sales soared for the world's top-selling drug, Humira. Read more...                      

CHMP Recommends MA for Diabetes Drug

July 25, 2014 11:24 am | News | Comments

Novo Nordisk announced that the Committee for Medicinal Products for Human Use under the European Medicines Agency adopted a positive opinion, recommending marketing authorization for Xultophy for the treatment of type 2 diabetes mellitus in adults. Read more...

FDA Reviews What Could Be First Biosimilar

July 25, 2014 11:20 am | News | Comments

The Food and Drug Administration is reviewing research data on what could become the first U.S.-approved "biosimilar" drug, a cheaper, sort-of generic version of a biologic drug, nearly five years after Congress passed a law enabling future approval of biosimilars. Read more...

Blood Cancer Drug Gets Positive CHMP Opinion

July 25, 2014 11:09 am | News | Comments

Gilead Sciences Inc. announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion on the company's Marketing Authorization Application for Zydelig, a first-in-class treatment for patients with chronic lymphocytic leukemia and follicular lymphoma. Read more...

Genomics Reveals Mechanism for Malaria Drug Resistance

July 25, 2014 10:58 am | News | Comments

Researchers have uncovered a way the malaria parasite becomes resistant to an investigational drug, a  discovery made at Washington University School of Medicine in St. Louis that also is relevant for other infectious diseases including bacterial infections and tuberculosis. Read more...

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