The regulatory body for the NHS in England and Wales has requested additional information from Genzyme prior to making a decision on the submission of Lemtrada. The National Institute for Health and Care Excellence (NICE) are currently unlikely to recommend the use of Genzyme’s Lemtrada (alemtuzumab) for relapsing, remitting multiple sclerosis, as a result of
Johnson & Johnson (J&J) has announced that they have received regulatory approvals on both sides of the Atlantic for Olysio and Invokana. The US regulatory body, the Food and Drug Administration (FDA), approved Olysio (simeprevir) on Friday to treat chronic hepatitis C virus infection. The drug was co-developed with Sweden’s Medivir.
As part of the continued growth of the Clinical Professionals Group, we have recently launched our Regulatory function to become a company in its own right – “Regulatory Professionals”. The Regulatory Affairs team within Clinical Professionals has already made a positive impact to our customers over the last 7 years with 9 out 10 customers
Novo Nordisk has received approval from US regulatory body, the Food and Drug Administration (FDA) for their haemophilia A drug. The regulatory board have approved the Novo Nordisk’s Biologics License Application for Novoeight (turoctocog alfa), a third-generation recombinant coagulation factor VIII.
Scottish regulatory body, the Scottish Medicines Consortium (SMC), have approved Roche’s MabThera (rituximab) for the National Health Service (NHS) in Scotland. MabThera has been approved to treat two potentially life-threatening illnesses, GPA and MPA.