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FDA accepts to review Merck and Sanofi Pasteur’s BLA for pediatric hexavalent vaccine By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Merck and Sanofi Pasteur's Biologics License Application (BLA) filed for their investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB.
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Ampio reports results of multiple intra-articular injections (MI) study of Ampion in patients with osteoarthritis of the knee Ampio Pharmaceuticals, announced updates for the STRUT and STRIDE multiple injection studies that are proceeding simultaneously.
Drug Research > Drug Delivery > News Vaxart’s tablet vaccine for H1N1 influenza generates protective immunity equivalent to injectable in Phase I clinical study Vaxart, a privately held, clinical-stage company developing recombinant vaccines that are administered by tablet rather than by injection, has announced clinical results demonstrating that its H1N1 tablet vaccine generates protective immunity comparable to currently licensed influenza vaccines, as measured by hemagglutinin inhibition assay (HAI), the established correlate of protection.
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SELLAS selects PPD as strategic CRO partner to advance Zolpidem and WT1 cancer vaccine
SELLAS Life Sciences Group, a Swiss-based development-stage biopharmaceutical company, has signed a definitive master service agreement with Pharmaceutical Product Development (PPD), a leading global contract research organization (CRO), to advance and expand clinical and regulatory development across Sellas' portfolio of drugs and biologics.
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Caldolor reports favorable inflammatory response results in laparoscopic cholecystectomy surgery patients
Cumberland Pharmaceuticals (CPIX) has announced that preoperative intravenous ibuprofen improved overall quality of recovery in patients undergoing laparoscopic cholecystectomy surgery.
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Drug-infused nanoparticle is right for sore eyes
By PBR Staff Writer
For the millions of sufferers of dry eye syndrome, their only recourse to easing the painful condition is to use drug-laced eye drops three times a day. Now, researchers from the University of Waterloo have developed a topical solution containing nanoparticles that will combat dry eye syndrome with only one application a week.
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FDA Approves Velcade for untreated mantle cell lymphoma
By PBR Staff Writer
The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved VELCADE® (bortezomib) for injection for use in previously untreated patients with mantle cell lymphoma (MCL).
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Novartis' Lucentis obtains Health Canada approval for visual impairment due to CNV
By PBR Staff Writer
Novartis Pharmaceuticals Canada has received approval from Health Canada for Lucentis (ranibizumab) to treat visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV).
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Pinnacle begins Phase III bile duct cancer trial of PHOTOFRIN
By PBR Staff Writer
Concordia Healthcare subsidiary Pinnacle Biologics has started an open-label, multicenter Phase III trial (OPUS) designed to evaluate the efficacy and safety of Photodynamic therapy (PDT) with PHOTOFRIN (porfimer sodium) for injection to treat cholangiocarcinoma (CCA).
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Bio-Path completes cohort six of liposomal Grb-2 Phase I trial for blood cancers
By PBR Staff Writer
US-based biotechnology firm Bio-Path Holdings has completed cohort six of its Phase I clinical trial evaluating lead compound, Liposomal Grb-2, in blood cancers.
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FDA approves EYLEA injection for macular edema following retinal vein occlusion
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals' EYLEA (aflibercept) Injection to treat macular edema following Retinal Vein Occlusion (RVO), which includes macular edema following Branch Retinal Vein Occlusion (BRVO) in addition to the previously-approved indication of macular edema following Central Retinal Vein Occlusion (CRVO).
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Sagent recalls three lots of Ketorolac Tromethamine Injection, USP, 30mg/ml
By PBR Staff Writer
Sagent Pharmaceuticals has recalled three lots of Ketorolac Tromethamine Injection, USP, 30mg/ml single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare and distributed by Sagent.
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Horizon gets FDA orphan drug status for ACTIMMUNE to treat Friedreich's Ataxia
By PBR Staff Writer
Irish biopharmaceutical firm Horizon Pharma has received orphan-drug designation from the US Food and Drug Administration (FDA) for ACTIMMUNE (Interferon gamma-1b) to treat Friedreich's ataxia (FA), a rare, genetic disease.
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