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European Medicines Agency

Latest Headlines

Latest Headlines

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.

EMA seeks input on new guidelines to combat antibiotics resistance

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.

Singapore clinician's PAH insight offers window on 'Dallas Buyers Club' for orphan therapies in Asia

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.

European regulators chart record year for new animal health products

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.

Samsung Bioepis advances its Enbrel biosimilar to an EMA review

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.

EMA posts guide to help IT teams with its new pharmacovigilance database

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.

AstraZeneca's $1.3B gout drug comes under EU scrutiny

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.

Ombudsman pushes EMA for explanation of Humira CSR redactions

The EMA responded quickly to the publication of the letter, issuing a release to outline its approach to the redaction of commercial confidential information.

EU's top regulator canned on a technicality

The European Medicines Agency didn't follow procedure when it appointed Executive Director Guido Rasi, a court has ruled, forcing the continent's top drug regulator to step down and sending the organization scrambling for answers.