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FDA Approves Expanded Use of Imbruvica

July 29, 2014 | Comments

The FDA has approved the supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Read more...        

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Daily news and top headlines for drug research professionals

Cancer Challenge Attracts Anonymous $100M Gift

July 29, 2014 2:54 pm | Comments

Oregon Health & Science University’s Knight Cancer Institute has received a $100 million gift to fuel its ambitious vision to stop cancer in its tracks. Read more...                       

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Neurotrope Initiates Phase 2a Alzheimer's Treatment Study

July 29, 2014 2:48 pm | Comments

Neurotrope Inc. announced that it has initiated a Phase 2a clinical trial to evaluate bryostatin for the treatment of patients with Alzheimer's disease (AD). Read more...                       

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Glaucoma Drug Gets EU Approval

July 29, 2014 11:18 am | Comments

Alcon, the global leader in eye care and a division of Novartis, announced that Simbrinza eye drops suspension has been approved by the European Commission to decrease elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction. Read more...

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Artes, Burnet Institute Partner on Malaria Vaccine

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

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European Commission Approves Leukemia Drug

July 29, 2014 11:04 am | 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...

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Merck Serono Kicks Off Study of Merkel Cell Carcinoma Drug

July 29, 2014 10:59 am | 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 | 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...    

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Biologists Think Stem Cells May “Talk” to Each Other

July 29, 2014 10:47 am | 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...

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FDA Rejects Zalviso Pain Treatment System

July 28, 2014 12:45 pm | 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... 

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AstraZeneca, QIAGEN Collaborate on Iressa Diagnostic Test

July 28, 2014 12:38 pm | 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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Scientists Discover New Mechanism of Drug Resistance

July 28, 2014 12:31 pm | Comments

Microorganisms can evade treatment by acquiring mutations in the genes targeted by antibiotics or antifungal drugs. Now, a new study has shown that microorganisms can use a temporary silencing of drug targets to gain the benefits of drug resistance without the commitment. Read more...

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Cancer Drug Shows Promise as Infertility Treatment

July 28, 2014 12:26 pm | Comments

Physicians may have a new drug to treat infertility in women with polycystic ovary syndrome, according to a national, multi-center clinical trial. Read more...                          

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HIV Inhibitor May Also Block Herpes Infection

July 28, 2014 12:19 pm | 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...

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MedImmune Fights Pediatricians' New Advice

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

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FDA Clears IND for Lorus Blood Cancer Drug

July 28, 2014 10:53 am | 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...

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