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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)
I don't suspect this combination will be very effective in weight loss. Topiromate has some mild Weight loss effect but Phentermin's effets on weight is at best questionable.
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.