Pharma News

Ionis Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to IONIS-HTTRx for the treatment of patients with Huntington's disease (HD). IONIS-HTTRx is the first therapy to enter clinical development that is designed to directly target the cause of the disease by reducing the production of the protein responsible for HD. IONIS-HTTRx has also been granted orphan drug designation by the European Medicines Agency for the treatment of patients with HD.

United-Guardian, Inc.  announced  that it has received FDA approval of its Supplemental New Drug Application to market a new single-dose form of Renacidin® (Citric Acid, Glucono delta-Lactone, and Magnesium Carbonate), the company’s proprietary irrigating solution that is used to prevent and dissolve calcifications in indwelling catheters.

A small molecule drug combined with chemotherapy may effectively treat colorectal cancer patients, says a new study.

GlenmarK Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), has announced the discovery and initiation of IND-enabling studies for a novel clinical development candidate, GBR 1342. GBR 1342 is a CD38xCD3 bi-specific antibody based on Glenmark’s proprietary BEAT® platform. GBR 1342 is the second clinical development candidate (following GBR 1302 a HER2xCD3 bi-specific antibody) based on the BEAT® technology. It is also Glenmark’s second clinical candidate targeting oncology indications.

Blocking a receptor in the brain responsible for regulating immune cells could protect against the memory and behaviour changes seen in the progression of Alzheimer's disease, says a new study.

Small differences in a particular region of the mouse genome can alter nicotine consumption, a new study has found.

Union Chemicals and Fertilizers Minister Ananth Kumar on Thursday said pricing regulation, FDI policy and 'Make in India' campaign are the important initiatives taken up by the Narendra Modi government for the pharmaceutical sector.

Gavi, a global vaccine alliance, has announced a partnership with the government here to accelerate access to modern, highly-efficacious vaccines to support India's immunisation programme, it was announced on Thursday.

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MabVax Therapeutics Holdings, Inc., a clinical-stage oncology drug development company, announces that it has received notice from the U.S. Food and Drug Administration (FDA) authorizing the initiation a Phase I clinical trial with HuMab-5B1 as a therapeutic treatment for pancreatic cancer.  The Company filed an Investigational New Drug (IND) application for its lead fully human antibody product on November 30, 2015.  Patient enrollment in the Phase I clinical trial is expected to begin at multiple investigational sites in early 2016.

MannKind Corporation announced the termination of its license and collaboration agreement with sanofi-aventis U.S. LLC for the development and commercialization of Afrezza® (insulin human) Inhalation Powder.