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Should The FDA Require CV Outcome Studies For Diabetes Drugs Before Approval?

As the waistline of Americans has increased, so has the incidence of Type 2 diabetes. Startling data from the Centers for Disease Control  shows that that prevalence of this disease, which is directly related to obesity, now exceeds 9% in the adult population. It was less than half that rate in 1996. Furthermore, there doesn’t […]

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Diabetes Drugs Get Neither Restrictions Nor Endorsements From FDA Committee

Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical  trials with the drugs be added to the drugs’ labels. […]

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FDA panel backs safety updates for AstraZeneca, Takeda drugs

A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. Reuters/Phil Noble (Reuters) – AstraZeneca Plc’s diabetes drug Onglyza and Takeda Pharmaceutical Co.’s rival product Nesina should carry information about the risk of heart failure, an advisory committee to the U.S. Food and Drug Administration said on Tuesday.   Heart […]

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Soligenix Completes Phase 1 Clinical Study with SGX203 for the Treatment of Pediatric Crohn’s Disease

Princeton, NJ – June 28, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that it has enrolled and treated all patients in the Phase 1 Study BDP-PCD-01; the […]

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Genentech’s Leukemia Drug Gets Priority Review

FDA Grants Genentech’s Obinutuzumab (GA101) Priority Review for Previously Untreated Chronic Lymphocytic Leukemia (CLL) Announcement Follows FDA Breakthrough Therapy Designation for GA101 in CLL FDA Decision on the GA101 Biologics License Application (BLA) Is Expected by the End of 2013. South San Francisco, Calif. — July 2, 2013 — Genentech, a member of the Roche […]

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Patients Show No Signs of HIV after Bone Marrow Transplant

HIV Positive Men Show No Signs of HIV after Bone Marrow Transplant and Discontinuation of Anti-Retroviral Therapy Boston, MA – Two Brigham and Women’s Hospital patients with longstanding HIV infections who underwent bone marrow transplants have stopped anti-retroviral therapy and have no detectable HIV in their blood cells.  One patient stopped anti-retroviral therapy 15 weeks […]

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FDA OKs Novartis’ Exelon Patch for Severe Alzheimer’s

Novartis Exelon® Patch now FDA approved to treat patients across all stages of Alzheimer’s disease Latest FDA approval based on high dose Exelon Patch 13.3 mg/24h for severe Alzheimer’s; 24-week study showed statistically significant improvement in overall cognition and function compared to 4.6 mg/24h dose Exelon Patch first and only transdermal therapy approved to treat […]

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2nd Annual Review: CNS/Neurology 2013

Click to download the PDF to view the full issue CNS Neurology Awaiting Approval (Excel Document) New Alzheimer’s disease treatments for presymptomatic patients will increase the Ad market size in the years ahead; the multiple sclerosis segment is undergoing a strong growth phase based on the arrival of promising molecules with disease-modifying characteristics and novel […]

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