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European Medicines Agency

Latest Headlines

Latest Headlines

EU-wide ban starts Aug. 21 on 700-plus drugs tested by India's GVK Bio Sciences

A European Union-wide ban on more than 700 drugs that were bioequivalency tested by India's GVK BioSciences will come into effect on Aug. 21 in a move that New Delhi had tried to head off with diplomatic efforts.

Fallout from India's GVK means $1B lost in drug exports by March 2016

The fallout from a European Union-wide ban on more than 700 drugs that were bioequivalency-tested by India's GVK BioSciences could cost India at least $1 billion in exports by the end of the fiscal year in March 2016, the Economic Times reports.

India's drug and CRO manufacturing travails gather pace as New Delhi calls on diplomats to help

Repeated quality violations by Indian drug manufacturing and contract research firms are casting a long shadow on the country's hopes to be a key global supplier of medicines and services. And they come at a particularly acute time for Biocon, which opens an initial public offering for its Syngene unit next week.

EMA to again place HPV vaccines under its safety lens

While the European Medicines Agency said it "does not question that the benefits of HPV vaccines outweigh their risks," on Monday it announced a safety review of the shots that have thus far failed to live up to expectations partly due to safety concerns and a sex-related stigma.

More trouble for India's CROs as Quest Life Sciences hauled up by WHO in HIV trial

Indian CRO Quest Life Sciences of Chennai saw the results of a clinical trial of HIV drugs rejected by the World Health Organization after an inspection found poor clinical practices on data and bioanalytical procedures that could not be remediated, according to a letter from the Geneva-based United Nations body.

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.