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Xeloda, an oral agent, was non-inferior to infusional 5-FU, when combined ith oxaliplatin in a randomized trial in patients with metastatic colrectal cancer (m-CRC) In fact, Xeloda containing regimen was assocaited with less myelosuppression, but more rashes and diaarhea. This is good news for...
Genetech has an impressive inventory of block-buster drugs: Avastin, Rituximab, and Herceptin, whose sales have been increasing on a regular base. Hereceptin and Avastin will be getting more and more use with new indications and longer dosing schedules. However, given the sagging economy...
Affymax's Hematide is a long acting synthetic peptide that stimulates erythropoietin and acts as an ESA. Together with Takeda, the company sponsored a phase II trial that showed safety and efficacy in patients with chronic renal failure; phase 3 trials are underway. This drug amy overtake the currently...
An indian product similar to Amgen's Filgastrim " G-CSF" showed comparable efficacy and safety in a trial in Europe and is expected to get EMEA approval in 2010. " Neukine" is already in use in India and in several "developing countries" in the MiddlE Esat and Asia where it is available at less...
Antigenics' Oncophage is a form of immunotherapy for patients with intermediate risk renal cancer that showed efficacy in improving recurrence free survival in a randomized trial . The approval in Russia, may be due in addition to the obvious reason of less regulatory restrictions, is that the company...
Immunomedics has developed three new immunoconjugates between monoclonal antibodies and SN-38 i an effort to target colon, pancreas and lung cancer. Preclinical data are effective in a metastatic colon cancer model but there are no clinical data.
FDA panel recommned approval of Amgen's Nplate for patients with refractory/recurrent chronic ITP who have failed other therapies like steroids, immunoglobulins, Rituximab and spleenectomy. The safety/efficacy profile was favorable for this relatively narrow indication, although long term safet issues...
An FDA panel recommended NOT to use ESA's for treatment of chemotherapy induced anemia in Breast cancer patients and head and neck acncer patients, a significant number of cancer patients. It also voted overwhelmingly to limit ESA's for non-curable cancer patients in the setting of palliative care....
FDA's approval of Genentech's Avastin is backed both by efficacy data and aggressive political activism. Extension of PFS by almost 6 months and shrinking large tumors, thus improving quality of life, are tangible and real beneficial effects. Avastin was already being prescribed off-label. The approval...
Pfizer's Irinotecan ( CPT-11) is mostly used in colorectal cancer with some limited use in sarcomas, glioblastoma multiforme, and other solid tumors. Teva's generic compound is expected to be cheaper, and with current economic situation, may be mandated by third party payers to cut costs, and this will...