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.
The Marketing Authorization Application for SB4, the Enbrel (etanercept) biosimilar candidate developed by Korean biopharmaceutical company Samsung Bioepis, has been validated and accepted for review by the European Medicines Agency. It will become the first Enbrel biosimilar subjected to regulatory review in the European Union.
The European Medicines Agency (EMA) has taken another step toward the creation of a database of all suspected adverse reactions reported within its jurisdiction. The EMA laid out the technical details of the system and how it will affect biopharma companies in a 100-page guide it published this week.
The European Medicines Agency has accepted AstraZeneca's application for lesinurad, a gout treatment with a checkered efficacy record, stoking the company's hopes that it can make the drug into a blockbuster.