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A new class of antigens has been identified that may be a contributing factor to type 1 diabetes. Type-1 diabetes is the auto-immune form of diabetes, in which insulin-producing beta cells in the pancreas are destroyed by body's own immune cells, a study finds.
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Enriching T cells a type of white blood cell to attack certain cancerous diseases may prove beneficial to an increasing number of children during immunotherapy, says a study.
Long-term use of liraglutide, a drug used to lower blood sugar levels in type 2 diabetes patients, can have a deteriorating effect on insulin-producing cells, leading to an increase in blood sugar levels, warns a study.
Cellceutix Corporation will be submitting a Special Protocol Assessment (SPA) request for phase 3 clinical research of its novel single-dose antibiotic, Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria. The Company anticipates submission of the SPA request to the U.S. Food and Drug Administration (FDA) within two weeks.
AstraZeneca and its global biologics research and development arm, MedImmune, have entered into a collaboration with the University of Michigan and Eli Lilly to identify new therapeutic targets for the treatment of chronic kidney diseases (CKD).
Alkermes plc. initiated second of two core phase 3 studies for ALKS 3831, an investigational, novel, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia.
Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for its biosimilar to Amgen’s EU-licensed Neulasta®* (pegfilgrastim) – a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product.
KemPharm, Inc. announced that the New Drug Application (NDA) for KP201/APAP, its investigational drug candidate for the short-term management of acute pain, has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA). In addition, the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.
Aurobindo Pharma Limited announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 500 mg/100 mL (5 mg/mL), and 750 mg/150 mL (5 mg/mL), single-use containers. The product is expected to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Levaquin® (Levaquin in 5 % Dextrose) by Janssen Pharmaceuticals, Inc.
Do you experience frequent mood swings? Scientists have found a group of drugs that could help treat mood disorders and also relieve chronic pain.
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