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Applied Genetic Technologies Corporation a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, announced that it has filed an Investigational New Drug application (IND) with the U.S. Food and Drug Administration to conduct a Phase 1/2 clinical trial of the company's gene therapy product candidate for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene.
Dr. Rao Vadlamudi, President of Indian Pharmaceutical Association (IPA), has been elected as President of Commonwealth Pharmacists Association (CPA) for the year 2017-19 at CPA Conference held at Hyatt Regency, Sydney, Australia from 28 - 30, July 2017. Dr. Rao Vadlamudi is the second Indian professional to be elected as CPA President after a gap of 30 years.
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.
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