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Process & Production

USPTO issues patent for VG Life Sciences covering treatment of IBD with CLIP-Inducing agent VG Life Sciences, a biotechnology company developing therapies for autoimmune and infectious diseases, announced the US Patent and Trademark Office (USPTO) has issued U.S. Patent No. 8906846, covering a method of treating inflammatory bowel disease (IBD) through the administration of a CLIP-inducing agent.
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MediciNova gets new patent covering MN-029 (denibulin) di-hydrochloride in Japan MediciNova, a biopharmaceutical company, announced that it has received a new patent from the Japanese Patent Office which covers MN-029 (denibulin) di-hydrochloride.
Production & Manufacturing > Process & Production > News OncoMed's cancer drug tarextumab gets FDA orphan drug status By PBR Staff Writer
OncoMed Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration's Office of Orphan Products Development (OOPD) for tarextumab (anti-Notch 2/3, OMP-59R5) to treat both pancreatic cancer and small cell lung cancer.
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FDA grants orphan drug status for RestorGenex' RES-529 to treat glioblastoma multiforme
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for US-based biopharmaceutical firm RestorGenex's RES-529, a first-in-class inhibitor of the PI3K/Akt/mTOR pathway, to treat glioblastoma multiforme.
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FDA accepts MediciNova's IND for MN-001 to treat NASH
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted MediciNova's investigational new drug (IND) application for its orally bioavailable small molecule compound, MN-001 (tipelukast), to treat nonalcoholic steatohepatitis (NASH), a common liver disease.
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Apricus Biosciences announces issuance of US Patent for RayVa
Apricus Biosciences, a biopharmaceutical company advancing innovative medicines in urology and rheumatology, announced that, January 27, 2015, the United States Patent and Trademark Office (USPTO) issued to Apricus, U.S. Patent No. 8,940,794, titled "METHODS AND COMPOSITIONS FOR TREATING RAYNAUD'S DISEASE," with claims generally directed to methods for treating Raynaud's phenomenon, that is secondary to systemic sclerosis.
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TiGenix gets European patent relating to adipose-derived stem cell composition
TiGenix, an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of allogeneic expanded adipose-derived stem cells in inflammatory and autoimmune diseases, announced that the European Patent Office (EPO) has issued European Patent EP2292736 relating to an adipose-derived stem cell composition.
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Aprea's ovarian cancer drug candidate APR-246 gets European orphan drug status
By PBR Staff Writer
Swedish biotech company Aprea has secured orphan drug designation from the European Medicines Agency (EMA) for its anti-cancer agent APR-246 to treat ovarian cancer.
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EMA accepts AstraZeneca's MAA for gout treatment lesinurad
By PBR Staff Writer
The European Medicines Agency has accepted AstraZeneca's marketing authorisation application (MAA) for lesinurad 200mg tablets for the chronic treatment of hyperuricaemia in combination with xanthine oxidase (XO) inhibitors allopurinol or febuxostat in gout patients when additional therapy is warranted.
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OncoSynergy's cancer drug OS2966 gets FDA orphan drug status
By PBR Staff Writer
US-based biotechnology firm OncoSynergy has received orphan drug designation from the FDA's Office of Orphan Products Development (OOPD) for OS2966, a first in class humanized monoclonal antibody, to treat ovarian cancer.
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UCB announces US and EU regulatory filings for brivaracetam
UCB announced regulatory milestones in the US and the EU for its investigational antiepileptic drug brivaracetam.
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Pharmalink's IND application for IgA Nephropathy now open with FDA
By PBR Staff Writer
Sweden-based specialty pharma company Pharmalink has announced that its investigational new drug (IND) application for Nefecon is now open with the US Food and Drug Administration (FDA).
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FDA grants fast track status for Celator's leukemia drug CPX-351
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation for Celator Pharmaceuticals' CPX-351 (cytarabine:daunorubicin) to treat elderly patients with secondary acute myeloid leukemia (AML).
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