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EMA validates Validates Gilead’s MAA for chronic hepatitis C therapy The European Medicines Agency (EMA) has validated and is assessing Gilead Sciences’ Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients.
Drug Research > Drug Delivery > News
aTyr Pharma's Resolaris secures FDA fast track status The US Food and Drug Administration (FDA) has granted Fast Track designation for aTyr Pharma's Resolaris to treat limb girdle muscular dystrophy 2B (LGMD2B).
Drug Research > Drug Delivery > News Mallinckrodt to pay $100m to settle US charges on drug pricing By PBR Staff Writer
Mallinckrodt has agreed to pay $100m to settle the US Federal Trade Commission (FTC) and state charges that it illegally maintained its monopoly of specialty drug used to treat infants.
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MonoSol Rx files patent infringement case against BioDelivery Sciences International
MonoSol Rx has filed a patent infringement case against BioDelivery Sciences International (BDSI) for infringement of U.S. Patent No. 8,765,167 (the ‘167 patent), which is entitled “Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions.”
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Kalobios secures green light from FDA to proceed with Chagas disease drug
KaloBios Pharmaceuticals announced positive guidance from a recent meeting with with the US Food and Drug Administration (FDA) to discuss the development plans for benznidazole to treat Chagas disease, a neglected tropical disease.
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RaNA Therapeutics acquires Messenger RNA Platform from Shire
RaNA Therapeutics has acquired the MRT platform, an mRNA therapy platform, developed by subsidiaries of Shire.
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Cannabics Pharmaceuticals unveils new dosage of 5mg THC Cannabis capsule
Cannabics Pharmaceuticals has unveiled a new dosage of 5mg THC Cannabis capsule to treat cancer patients suffering from Cachexia and Anorexia Syndrome.
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Factor One Source Pharmacy to buy Fast Access Specialty Therapeutics
Factor One Source Pharmacy (FOSRx) has agreed to acquire Fast Access Specialty Therapeutics (F.A.S.T.) for a combination of cash and stock.
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TetraLogic sells SMAC Mimetic and HDAC Inhibitor assets to Medivir
TetraLogic Pharmaceuticals has completed the sale of its SMAC Mimetic and HDAC Inhibitor assets to Medivir.
Drug Research > Drug Delivery > News
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