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- Read more about Guerbet receives FDA 510k clearance for the OptiOne™ single-head contrast delivery system
Guerbet announced that it has received 510K clearance from the US Food and Drug Agency (FDA) for its OptiOne™ Single-Head Contrast Delivery System, featuring advanced multi-purpose functionality for CT imaging procedures.
- Read more about RedHill Biopharma announces successful PK study With BEKINDA™ 12 mg and submission to FDA of IBS-D Phase II study Protocol
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.
- Read more about Scientists identify antigens that may trigger type 1 diabetes
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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- Read more about Younger T cells may improve immunotherapy for cancer in kids
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.
- Read more about Liraglutide, diabetes drug can weaken insulin-producing cells
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.
- Read more about Cellceutix will submit SPA to FDA for phase 3 for treatment of ABSSSI
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.
- Read more about Astrazeca and Eli Lilly joined to discover treatment of CKD
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).
- Read more about Second Phase 3 Study of Alkermes antipsychotic drug
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.
- Read more about EMA accepts Sandoz application for pegfilgrastim biosimilar
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.
- Read more about FDA Grants Priority Review to KemPharm for KP201/APAP NDA
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.