Amicus Therapeutics has landed on the European regulatory fast track, potentially shortening the review time for its orphan drug as it prepares filings at home and abroad.
The European Medicines Agency is standing by its original recommendation made earlier this year to suspend a number of medicines that received European Union clearance based on clinical studies conducted by GVK Biosciences in India.
Cipla-backed Stempeutics, an Indian advanced clinical stage biotech company based in Bangalore, said it is the first company in the world to be granted a process patent by the State Intellectual Property Office of China for a stem cell drug treatment based on pooling technology that could potentially be used in the treatment of critical limb ischemia.
India drug authorities are mounting a full-court press against their European counterparts in defense of GVK Biosciences, a contract research organization under fire for alleged manipulation of trial data. The pushback includes a threat to sue and another to take the matter to the World Trade Organization.
Merck's new-and-improved Gardasil is making headway in Europe with the word late last week that the European Medicines Agency has recommended the jab against 9 types of human papillomavirus and will send its blessing to the European Commission.
Cipla-backed Stempeutics, an India advanced clinical stage biotech company based in Bangalore, said the European Medicines Agency has granted Advanced Therapy Medicinal Product classification for its novel stem cell drug Stempeucel.
South Korea's Samsung Bioepis has submitted a marketing authorization application to the European Medicines Agency for SB2, a biosimilar of autoimmune drug Remicade (infliximab) for moderate to severe rheumatoid arthritis.
Following in the footsteps of the FDA, the European Medicines Agency (EMA) has launched an effort to combat antibiotics resistance in people by targeting food animals. The agency has issued two new draft guidelines for assessing and approving veterinary antibiotics.
The clinical side of orphan drug use has many twists and turns, not least of which is matching patient ability to pay with the right drug and an openness to understand the dynamics of a "Dallas Buyers Club" approach to use.
The European Medicines Agency recommended 20 new veterinary drugs for approval in 2014--the highest number of positive opinions it has issued in the past 5 years in animal health.