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Anthera Pharmaceuticals announced that blisibimod has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Immunoglobulin A nephropathy (IgAN). Blisibimod targets B-cell activating factor, or BAFF, which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including IgAN, systemic lupus erythematosus, and others.
Manufacturers of the Medical Devices are required to obtain manufacturing license under the provisions of Drugs and Cosmetic (D&C) Act & Rules which is notified by Directorate General of Health Services, Ministry of Health & Family Welfare.
Sun Pharma to aquire US based Krystal Biotech in 7 million USD. Krystal Biotech is a biopharmaceutical company using gene therapy to develop treatments for patients suffering from rare debilitating disorders.
Central Drugs Standard Control Organization (CDSCO) emphasize on GMP and GLP compliance to pharmaceutical manufacturers. But it seems like pharma manufacturers are not serious about implementation of GMP and GLP for their manufacturing plants. Before one year, CDSCO asked manufacturers to carry out an assessment of their units and assign themselves quality ratings but so far Indian pharma manufacturers have not submitted self-inspection reports.
Pharma Major Lupin Limited (Lupin) announced that it has received a 505 (b) (2) NDA approval for its Nikita™ (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (FDA).
AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is an investigational, highly selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.
Zydus Cadila has received the final approval from the USFDA to market Temozolomide Capsules in strengths of 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg.
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Acyclovir Ointment USP, 5%, the generic version of Zovirax® Ointment, 5%, of Valeant International Bermuda.
RedHill Biopharma Ltd a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported, following a second pre-planned meeting to assess the safety and efficacy data from its ongoing first Phase III study with RHB-104 for Crohn’s disease (the MAP US study) by an independent Data and Safety Monitoring Board (DSMB), that it has received a unanimous positive recommendation from the DSMB to continue the study as planned.
AXIM Biotechnologies, Inc a world leader in cannabinoid research and development, today announced that it has entered into a Clinical Study Agreement (CSA) with the University of British Columbia in Canada to begin a clinical trial with its CanChew Plus® cannabidiol (CBD) chewing gum product to treat drug-induced psychosis in adult patients.
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