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BioWorld Science

Nov. 25, 2015

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FDA gives orphan drug designation to intranasal diazepam

BHV-0223 shows favorable pharmacokinetics in phase I trial

ObsEva and Kissei sign development and commercialization agreement for KLH-2109

Baxalta seeks clearance for first-in-human study of BAX-826 extended half-life rFVIII treatment

PD-L1 shows potential as a prognostic biomarker for meningioma

Roivant Sciences licenses PDE4 inhibitor E-6005 from Eisai

Symberix awarded multiple SBIR grants to develop microbiome-targeted drugs

ZAI Lab and Hanmi to develop novel EGFR-targeted therapy for lung cancer in China

Cellceutix gets FDA orphan drug designation for Kevetrin, completes enrollment in Prurisol study

AGTC's achromatopsia gene therapies granted orphan drug designations

Phase III trial of ofatumumab in follicular lymphoma to be stopped early due to lack of efficacy

PEGylated Mdm2 antagonist prodrug shows encouraging antitumor activity

Kitov Pharmaceuticals announces initial public offering

Green Cross seeks U.S. approval for IVIG-SN for primary immunodeficiency diseases

Zutectra receives positive CHMP opinion for use after liver transplantation

Entresto receives E.U. approval

FDA approves Portrazza for metastatic squamous NSCLC

Women's health specialist Pivot Pharmaceuticals completes acquisition of IndUS Pharmaceuticals

Angion's CYP11B2 inhibitor shows potential for CKD in animal models

FDA decides not to approve Indivior's naloxone nasal spray for opioid overdose

Sunshine Lake Pharma patents 5-HT reuptake inhibitors

ESSA Pharma starts phase I/II trial of prostate cancer candidate EPI-506

Orion develops GABA-B receptor PAMs

University of Colorado discloses TLR2 agonists

Bristol-Myers Squibb reports GPR40 modulators

Lycera presents ROR-gamma agonists

FDA approves Opdivo for previously untreated BRAF V600 wild-type advanced melanoma

University of Ulster describes apelin receptor agonists

Microvesicle hsa-microRNA-223-3p, a promising biomarker to differentiate OA and RA

Multikinase inhibitor RXDX-105 well tolerated to date in phase I trial in solid tumors

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