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> FDA OKs sNDA for Second Generation Veletri
> Japan Approves Astellas’ Gonaxfor Subcutaneous Injection
> Anthera Pharma Plunges on Lupus Drug Study Results
> Finding Brings Scientists One Step Closer To Parkinson's Drug
> Gilead Sciences Files for Approval of Cobicistat |
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| Cardiovascular |
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FDA OKs sNDA for Second Generation Veletri
Marketwire - Jun. 29, 2012
Actelion Pharmaceuticals announced the FDA approved their sNDA for second generation Veletri, for the treatment of pulmonary arterial hypertension.
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| Oncology |
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Japan Approves Astellas’ Gonaxfor Subcutaneous Injection
ENP Newswire - Jun. 29, 2012
Astellas Pharma announced that Gonaxfor Subcutaneous Injection was granted Japanese marketing approval today for the indication of prostate cancer.
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Data from New Drug Trial Offers Prospect for Enhanced Quality of Life for Children with Late Stage Brain Tumors
From the PharmaLive.com News Archive - Jun. 27, 2012
Data showed encouraging positive results from a Phase I/II study of Xerecept in Pediatric Patients with Peritumoral Cerebral Edema (brain tumors). Xerecept is an investigational new drug for use in pediatric patients who are dependent on the steroid Decadron (dexamethasone) to treat peritumoral brain edema associated with cerebral tumors
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| Pain & Inflammation |
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Anthera Pharma Plunges on Lupus Drug Study Results
Associated Press - Jun. 28, 2012
Anthera Pharmaceuticals said Lupus drig blisibimod did not meet its goals in a clinical trial, because two of the three doses it studies were not effective when compared to a placebo. The company said patients who received 200 milligrams of blisibimod per week experienced improvement, but those who received 100 milligrams per week or 200 milligrams per month did not do significantly better than patients who were given a dummy shot.
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Tonix Pharmaceuticals Receives Health Canada Clearance to Study a Novel Treatment for Fibromyalgia
From the PharmaLive.com News Archive - Jun. 27, 2012
Tonix Pharmaceuticals said it will initiate a comparative study on a novel treatment for FM that targets sleep problems associated with chronic pain syndromes. Tonix’s new approach is opiate-free and non-addictive.
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| Central Nervous System |
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Finding Brings Scientists One Step Closer To Parkinson's Drug
From the PharmaLive.com News Archive - Jun. 27, 2012
Van Andel Institute announces that researchers at Lund University in Sweden have published a study detailing how Parkinson's disease spreads through the brain. Experiments in rat models uncover a process previously used to explain mad cow disease, in which misfolded proteins travel from sick to healthy cells.
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First Patients Dosed in Ib Phase of Neuralstem's NSI-189 Trial in MDD
From the PharmaLive.com News Archive - Jun. 25, 2012
Neuralstem announced that the first patients were dosed in Phase Ib of its ongoing trial to test the safety of NSI-189 in the treatment of major depressive disorder. NSI-189, the lead compound in Neuralstem's small molecule platform, is a proprietary new chemical entity that stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated in MDD as well as other diseases and conditions, such as chronic traumatic encephalopathy , Alzheimer's disease, anxiety, and post-traumatic stress disorder.
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| Infectious Disease |
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Gilead Sciences Files for Approval of Cobicistat
Associated Press - Jun. 28, 2012
Gilead Sciences said it asked the FDA to approve its drug cobicistat, a component of its proposed four-in-one HIV pill. Cobicistat is designed to boost blood levels of some HIV drugs. It works by blocking an enzyme that breaks down drugs in the body. Gilead is studying cobicistat as part of the four-in-one Quad pill, and the drug is also being studied in combination with Johnson & Johnson’s drug Prezista and Bristol-Myers Squibb Co.’s Reyataz.
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Consortium Concludes Preclinical Development of DNA Vaccine Against Leishmaniasis
From the PharmaLive.com News Archive - Jun. 27, 2012
The Leishdnavax consortium, with Mologen AG as a key partner has successfully concluded the preclinical development of a MIDGE-based vaccine against leishmaniasis (MGN1331). Within the framework of the project, the new human vaccine has been examined as to its efficacy and safety in animal models, for prophylactic as well as therapeutic applications. MGN1331 showed outstanding results.
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