After much delay, the EMA finally gears up for trial transparency drive
The EMA has published new rules as it prepares for a watershed year that will see the life science industry in Europe make public more clinical trial data than ever before.
Lilly moves toward psoriasis showdown with Novartis in EU
Look out, Novartis. Eli Lilly is now one step closer in the EU to challenging the Swiss pharma's new psoriasis standout, Cosentyx, with its own next-gen therapy, ixekizumab.
EMA warns of PML, cancer risks from Novartis' Gilenya
Earlier this year, U.S. regulators updated the label of Novartis' multiple sclerosis pill, Gilenya, to reflect cases of serious brain infections linked to the treatment. And now, its counterparts across the pond are following suit.
Puma preps its once-vaunted cancer drug for European submission
Puma Biotechnology said European regulators have opened a path to approval for its in-development breast cancer drug, clearing the way for a treatment that has divided analysts over the past few years.
FT counts 39 plants banned in India as regulatory woes mount for drugmakers
A hard drumbeat of U.S. FDA complaints against more than two dozen companies in India for quality violations has affected 39 drugmaking facilities, creating an avalanche of remedial work that could take years and is steadily driving up medicine costs in the United States.
India defers EU trade talks as ban on GVK-tested drugs rankles
India has deferred planned trade talks with the European Union as a form of protest to a European Union-wide ban set to start this month on more than 700 drugs that were bioequivalency-tested by GVK BioSciences, India's Live Mint newspaper said.
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.
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.