FDA Advisory Committee Votes 12 to 2 That Benefits of ACADIA Pharmaceuticals’ NUPLAZID™ (Pimavanserin) for the Treatment of Psychosis Associated with Parkinson’s Disease Outweigh the Risks

SAN DIEGO--- ACADIA Pharmaceuticals Inc. (ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits of NUPLAZID™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease outweigh the risks of treatment.
 
The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the NUPLAZID New Drug Application (NDA) is May 1, 2016. The FDA has granted the NUPLAZID NDA Priority Review status and designated NUPLAZID for the treatment of psychosis associated with Parkinson’s disease as a Breakthrough Therapy.
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BriaCell Discovers Gene Signature of BriaVax(TM) Cancer Vaccine Consistent With Exceptional Efficacy in Clinical Trial

Data Presentation at an International Cancer Conference
 
BERKELEY, CA and VANCOUVER, BC--(March 29, 2016) - BriaCell Therapeutics Corp.("BriaCell" or the "Company")(TSX VENTURE: BCT) (BCTXF) is very pleased to announce that it has discovered a gene signature potentially explaining why its BriaVax™ cancer vaccine was exceptionally efficacious in a clinical trial subject with stage IV breast cancer. Data will be presented at the Annual Meeting of the American Association for Cancer Research (AACR) next month. The Company has focused its research efforts on identifying links between its cancer vaccine and responding patients.
 
"After sorting through tens of thousands of genes, it's very exciting to find a coherent set of biomarkers that may allow us to better understand the remarkable response observed in the previous Phase-I clinical trial," commented Dr. Markus Lacher, Head of BriaCell R&D. "We believe that the identification of this gene signature not only demonstrates the strength of our R&D program but also provides a foundation for a mechanism of action."
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Ohr Pharmaceutical, Inc. Announces SPA Agreement with US FDA and Initiation of Phase III Wet AMD Clinical Program

First of Two Planned Phase III Trials Initiated to Evaluate Squalamine (OHR-102) Combination Therapy for the Treatment of Wet AMD
 
NEW YORK, March 29, 2016  Ohr Pharmaceutical, Inc. (OHRP), a clinical-stage biotechnology company developing novel therapies for ophthalmic diseases, today announced that it has reached an agreement on the Special Protocol Assessment (SPA) with the United States Food and Drug Administration (US FDA) on the design of the Phase III trial for its lead drug candidate, squalamine lactate ophthalmic solution, 0.2% (“Squalamine,” also known as OHR-102).  Based on the agreed upon SPA, Ohr has initiated the first of two planned Phase III global clinical studies evaluating the efficacy and safety of Squalamine, given in combination with Lucentis®, for the treatment of neovascular age-related macular degeneration (wet AMD).
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Keryx Biopharmaceuticals Announces Positive Top-line Results from Pivotal  Phase 3 Study of Ferric Citrate for the Treatment of Iron Deficiency Anemia  in Adults with Non-Dialysis Dependent Chronic Kidney Disease

Registration trial demonstrated statistically significant differences versus placebo for the primary and all pre-specified secondary endpoints --- Majority of patients in the ferric citrate group (52 percent) achieved a 1 g/dL increase in hemoglobin vs. 19 percent in the placebo group --- Safety profile consistent with previously reported clinical studies --- Data support Keryx’s plan to submit a supplemental new drug application (sNDA) in the third quarter of 2016 seeking to expand ferric citrate’s indication --- Conference call to be held today at 8:00 a.m. ET
 
BOSTON, March 29, 2016 -- Keryx Biopharmaceuticals, Inc. (KERX), a biopharmaceutical company focused on bringing innovative medicines to market for people with renal disease, today announced positive top-line results for its pivotal 24-week Phase 3 study of ferric citrate, an oral, iron-based medicine in development for the treatment of iron deficiency anemia (IDA) in adults with stage 3-5 non-dialysis dependent chronic kidney disease (NDD CKD). The study met its primary endpoint and all pre-specified secondary endpoints with statistical significance.
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ContraVir's CMX157 Outperforms Gilead's Tenofovir AF (TAF) Against Hepatitis B Virus in Independent Head-to-Head In-Vitro Study

Results Confirm CMX157's Increased Potency Versus Tenofovir and Viread® and Provide First Direct Comparison to TAF
 
EDISON, N.J., March 29, 2016 -- ContraVir Pharmaceuticals, Inc. (CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, reported positive results from a third-party in vitro study that further validates CMX157's profile as a highly potent anti-hepatitis B drug.  In this first head-to-head in vitro study, CMX157 compared favorably to tenofovir alafenamide fumarate (TAF), which was approved recently by the US Food and Drug Administration (FDA) as part of a four-drug combination therapy for HIV-1 (Genvoya®), and is currently under development by Gilead Sciences Inc. (GILD) for treating chronic hepatitis B infection.  ContraVir recently initiated a Phase 1/2a clinical study of CMX157, which is currently enrolling healthy volunteers and is anticipated to begin enrolling hepatitis B patients in the second quarter 2016.
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