The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have announced that they will reinforce their efforts on medicines safety through regular collaborative meetings. The regulatory agencies confirmed that they will be forming a new pharmacovigilance ‘cluster’ to provide an opportunity to share information on the safety of medicines. The cluster
Alimera Sciences yesterday announced that the Scottish Medicines Consortium (SMC) has approved Iluvien as a treatment for chronic diabetic macular oedema (DME) for restricted use within the NHS in the country. Use of Iluvien will be restricted to patients in whom the affected eye is pseudophakic, meaning that they have an artificial lens after cataract
Regulatory body, the National Institute for Health and Care Excellence (NICE), have opened a second consultation on the use of Astellas’ Xtandi in patients with prostate cancer, after widening the drug’s target population. The regulatory affairs agency issued new draft guidance this morning recommending the use of Xtandi in adult patients with hormone relapsed metastatic
GlaxoSmithKline’s (GSK) Tafinlar (dabrafenib) was yesterday granted ‘breakthrough’ status by the US Food and Drug Administration (FDA), meaning it will be fast tracked through the US regulatory system. The US regulatory body granted authorisation to accelerate Tafinlar’s development as a drug for metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC), in patients who have
US regulatory body, the Food and Drug Administration (FDA), have announced that they have approved AstraZeneca’s diabetes drug Farxiga. The drug was approved by the regulatory body with the condition of AstraZeneca conducting six post-marketing studies, including a cardiovascular outcomes clinical trial.
Johnson & Johnson have announced that they have received regulatory approvals on both sides of the Atlantic for two of their key drugs, Olysio and Invokana. On Friday the US regulatory body, the Food and Drug Administration (FDA), approved Olysio (simeprevir) to treat chronic hepatitis C virus infection. The drug was co-developed by Johnson and
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.