Though not totally convinced about long-term effectiveness and patient adherence, NICE's decision not to restrict Lemtrada's indication could place it ahead of Gilenya and Tysabri for relapsing-remitting multiple sclerosis.
Genzyme Corp.'s Lemtrada (alemtuzumab) for multiple sclerosis has cleared the NICE reimbursement hurdle in the U.K. with an unrestricted indication. This potentially puts it as the front-runner in the race against rivals that include Novartis AG's Gilenya (fingolimod) and Biogen Inc.'s Tysabri (natalizumab).
NICE's current recommendation in final guidance published May 28 is a confirmation of its Final Appraisal Determination issued in April....
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
