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KAI secures CDC contract to support annual influenza vaccine serology testing KAI Research (KAI), a wholly owned subsidiary of Altarum Institute, announced today that the Centers for Disease Control and Prevention (CDC) awarded it a contract to evaluate samples of pediatric, adult, and elderly individuals’ serum levels after flu vaccination to determine whether antibodies induced by the current vaccine effectively inhibit circulating influenza viruses.
Drug Research > Drug Delivery > News
Otsuka gets FDA approval for dual-chamber syringe for abilify maintena to treat schizophrenia Otsuka Pharmaceutical Development & Commercialization and Lundbeck has announced that the US Food and Drug Administration (FDA) has approved a new formulation of Abilify Maintena (aripiprazole) for extended-release injectable suspension – a pre-filled dual-chamber syringe.
Drug Research > Drug Delivery > News Alimera's ILUVIEN gets FDA approval for diabetic macular edema treatment By PBR Staff Writer
Alimera Sciences has received approval from the US Food and Drug Administration (FDA) for ILUVIEN (fluocinolone acetonide intravitreal implant) to treat diabetic macular edema (DME).
Drug Research > Drug Delivery > News
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Takeda's NDA for fomepizole gets approval in Japan
By PBR Staff Writer
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the new drug application (NDA) of Takeda Pharmaceutical's Fomepizole Intravenous Infusion 1.5g 'Takeda' (fomepizole), an alcohol dehydrogenase inhibitor, to treat ethylene glycol and methanol poisonings.
Drug Research > Drug Delivery > News
EMA panel recommends European approval of cancer drug Lymphoseek
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization for Navidea Biopharmaceuticals' Lymphoseek 250 micrograms kit for radiopharmaceutical preparation (tilmanocept) in the European Union (EU).
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Abbvie gets FDA approval for Crohn's disease drug Humira
By PBR Staff Writer
AbbVie has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) to reduce signs and symptoms as well as achieve and maintain clinical remission, in pediatric Crohn's disease patients six years of age and older.
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MabVax receives orphan drug designation for therapeutic vaccine to treat childhood cancer neuroblastoma
MabVax Therapeutics Holdings, a clinical stage oncology drug development company, has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to the Company's vaccine intended for the treatment of the childhood cancer neuroblastoma.
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Cortex enters into agreement with the National Institute of Drug Abuse
Cortex Pharmaceuticals, a leader in developing drugs for respiratory disorders, including drug-induced respiratory depression, as well as obstructive, central and mixed sleep apnea, announces that effective September 18, 2014, the Company has entered into an agreement with the National Institute of Drug Abuse valued at $148,583 and entitled "Novel Treatment of Drug-Induced Respiratory Depression."
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FDA approves Noven's new dose for Minivelle to prevent postmenopausal osteoporosis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Noven Pharmaceuticals' new indication with a new dose of Minivelle (estradiol transdermal system) to prevent postmenopausal osteoporosis.
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Collegium announces issuance of US patent covering DETERx technology platform
Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that U.S. Patent No. 8,840,928 has been issued by the U.S. Patent and Trademark Office (USPTO). The issued patent covers the DETERx technology platform.
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Amdipharm Mercury launches hypertension drug Nicardipine in UK
By PBR Staff Writer
Amdipharm Mercury Company (AMCo) has launched Nicardipine injection in the UK for the treatment of acute life-threatening hypertension situations, such as encephalopathy, post operatively and eclampsia in pregnancy.
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Navidea gets $1.67m fast track NIH SBIR grant to evaluate lymphoseek in cervical cancer
Navidea Biopharmaceuticals has announced the receipt of an initial notice of award for a Fast Track Small Business Innovation Research (SBIR) grant providing for up to $1.67m from the National Cancer Institute (NCI), National Institutes of Health (NIH), to fund evaluation of Lymphoseek (technetium Tc 99m tilmanocept) Injection in women with cervical cancer.
Drug Research > Drug Delivery > News
Polipharma Industries - Pharmaceutical Product Manufacturer
Polipharma Industries is a GMP-certified drug manufacturer established in 2003, whose core business is the manufacturing of pharmaceutical products. We provide activities and services such as: research & development, out-licensing, contract manufacturing, contract development, batch release, analytical services and clinical trials.
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