FDA approves aflibercept for patients with wet AMD
November 21st 2011FDA has approved aflibercept (Eylea Injection, Regeneron), known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration in patients aged 60 and older at a recommended dose of 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).
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FDA revokes breast cancer indication for Avastin
November 18th 2011FDA Commissioner Margaret A. Hamburg, MD, announced the agency's decision to revoke the breast cancer indication for bevacizumab (Avastin), noting that the benefits do not outweigh the potentially life-threatening side effects, such as heart attack or heart failure, high blood pressure, bleeding and hemorrhaging, and the development of perforations in different parts of the body, such as the nose, stomach, and intestines.
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The Right Medicines for Different Genes
November 15th 2011The Archon Genomics X PRIZE presented by Medco will measure teams on accuracy, cost, speed and completeness of genome sequencing. The goal is to push the industry to develop, more accurate, faster and more cost effective sequencing technologies.
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Drug shortages challenge the healthcare community, FDA, and pharmaceutical manufacturers
November 1st 2011The outcry from physicians, pharmacists, and patients over disruptions in supplies of vital medicines to treat cancer, pain, and other serious conditions is drawing attention from the White House, Congress and the broader healthcare system.
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Creative contracting initiatives key for pharma as competition in RA market increases
November 1st 2011The rheumatoid arthritis payer market has experienced increasingly competitive forces, prompting RA drug manufacturers to experiment with new contracting initiatives to gain preferred formulary placement.
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Recent FDA action (through October 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001,cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127
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Crizotinib: A novel, targeted gene therapy for the treatment of non-small-cell lung cancer
November 1st 2011Crizotinib is a new kinase inhibitor recently approved by FDA for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who express the anaplastic lymphoma kinase gene.
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