The Expertise Imperative and Compliance Technology
Access to a diverse array of specialized expert inputs drives superior decisions in every organizational context: within corporations, by investors and consultancies, and within nonprofits. When decision makers are confident of their decision inputs, they can respond more quickly and creatively to challenges and opportunities.Learn more about GLG's Compliance Framework
This page may include content provided by Council Members, your access to which is subject to the Terms of Use.
Genentech will have more battles to fight in the future aside from Avastin. This medication appears extremely promising for the treatment of breast cancer, however, physicians are still mixed in their opinions about its place in the treatment of breast cancer.
The trend to utilize raw materials manufacturers outside the US is driven by dramatic cost savings and is certainly still rising. Chemistry controls should be specifically targeted to identify impurity profiles in the receipt and release testing of imported material. FDA could become more...
IVIg (intraveonus immunoglobulin) reduces disability and reduces risk of relapse in patients with CIDP (chronic inflammatory demyelinating polyradiculoneuropathy).
Talecris' form of IVIG, Gamunex was studied in the largest trial of IVIG in chronic inflammatory polyradiculoneuropathy (CIDP), with more than twice as many patients moving into remission. CIDP is a common acquired autoimmune peripheral neuropathy, which if not treated, may lead to a peripheral...
Quality is critical in human pharmaceutical processes from research and development through to manufacturing and commercialization of pharmaceuticals for human consumption. Slippage in quality norms may reflect an underlying shift in culture within an organization. FDA compliance and inspectional...
Somaxon Pharmaceuticals has submitted a NDA for Silenor for the treatment of insomnia. The active ingredient is doxepin, which has been available for years.The effect of the drug can be expected to be very modest, side effects unfavorable when compared to Ambien or Lunesta, and with both significant...
Xenoport's trial for XP13512 in restless legs syndrome (RLS) shows strongly positive 9 month data in second phase 3 trial, should be a major win in the marketplace. RLS represent a major unmet need, for drugs with sustained efficacy and high tolerability.
UCB has filed new drug application for regulatory approval for lacosamide through FDA and European Medicines Agency. Primary indication would be the treatment of partial onset seizures (epilepsy)
Mush of Elan's future will depend on the efficient and reasonable marketing of Tysabri. The fact that more than 33,000 patients now have been treated worldwide without any new cases of PML favors Elan's success.