Pharma News

RedHill Biopharma Ltd, announced the successful completion of a first-in-man pharmacokinetic (PK) study of BEKINDA™ 12 mg formulation, intended to be administered in the Phase II study for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). RedHill further announced the submission to the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) protocol for the Phase II clinical study with BEKINDA™ 12 mg for IBS-D, planned to be initiated in the coming weeks, subject to final preparations.

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.

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.