• India Moves to Grant Three More Compulsory Licenses for Cancer Medications Based on Cost

    • 03 May 2013
    India's Union Health Ministry is pursuing three more compulsory licenses that would allow generic manufacturers in the country to compete with patent-protected medicines, including Roche's Herceptin and Bristol-Myers Squibb's Sprycel and Ixabepilone, reports PharmaBiz .  The announcement comes just months after the country's Supreme Court issued a landmark compulsory license for Bayer's Nexavar (sorafenib). What made that decision so remarkable to both critics...
  • UK: NICE Says No to Two Breast Cancer Drugs

    In final guidance published 27 June, the UK's National Institute for Health and Clinical Excellence (NICE) does not recommend lapatinib (Tyverb, GlaxoSmithKline) or trastuzumab (Herceptin, Roche) with aromatase inhibitors as first line treatment options for metastatic breast cancer. The guidance notes it is unclear how much either drug can improve overall survival compared to existing treatments and as a result they do not represent value for money for the NHS. Th...
  • FDA Approves New Breast Cancer Drug Despite Manufacturing Concerns

    Genentech's application for Perjeta (pertuzumab ) won marketing approval from the US Food and Drug Administration (FDA) on 8 June, bringing to market a new-and expensive-biologic product for the treatment of advanced breast cancer. Perjeta is a humanized monoclonal antibody, and works in conjunction with Herceptin (trastizumab) to further reduce the growth of HER2-positive cancerous cells in breast cancer patients. The HER2 gene is associated with approximately 20...
  • UK: Two Breast Cancer Drugs not Recommended by NICE in Latest Draft Guidance

    The National Institute for Health and Clinical Excellence (NICE) will not recommend lapatinib (Tyverb, GlaxoSmithKline) or trastuzumab (Herceptin, Roche) with aromatase inhibitors for a particular type and stage of breast cancer, the agency said in a final draft guidance issued 26 April. The proposal notes that it is unclear how much either drug can improve overall survival compared to existing treatments and that the drugs do not appear t...