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European Medicines Agency

Latest Headlines

Latest Headlines

Sweden's Medivir deal lends support to embattled GVK

A deal by Sweden's Medivir to trim costs by entering into a partnership for drug research has thrown a bit of support to CRO GVK Biosciences, which faces a European Medicines Agency recommendation for the suspension of more than 700 products tied to its facility in India.

India's Polydrug Labs criticized for contaminated APIs

When any member of the European Union finds issue with a drugmaker, it is reported to a central database to alert other members that might also buy from that facility. Now Slovenia has raised red flags about an Indian drugmaker it says it discovered during an inspection is not meeting cGMP standards.

Samsung Bioepis, Celltrion propel South Korea to front ranks of biosimilar race

South Korea's Celltrion and Samsung Bioepis are poised to gain new or expanded approval for biosimilars of some of the world's best-selling biological drugs, setting up a regulatory knowledge base on approvals and bringing commercial competition to major drugmakers not unlike that seen by small-molecule generics from India decades ago.

Amicus' rare disease drug lines up for a quick EU approval

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.

EU's medicines agency stands by recommendation to suspend drugs studied at GVK India facility

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.

India's Stempeutics says China IP office grants process patent on stem cell ischemia candidate

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 defends GVK Biosciences in falsified trial data allegations

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.

Sanofi, Merck win EMA nod for Gardasil 9

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.

India's Stempeutics gets EMA advanced therapy designation for Stempeucel

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.

Samsung Bioepis JV with Biogen Idec moves on Remicade biosimilar in Europe

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.