China has said it will accept data from clinical trials run overseas in a bid to shorten the time it takes to approve new drugs and medical devices.
The EMA’s call for extra staff comes as it is bracing itself for the likely loss of employees when it moves from its current home in London.
In life sciences companies, collaboration is key. It’s important for operational leaders to partner with finance leaders to consider risks and issues that may…
The data tee Motif Bio up to file for approval of a drug that was knocked back by the FDA in 2009 and almost sunk the biotech 12 months ago.
Catabasis is looking to test its experimental Duchenne drug edasalonexent in a late-stage trial.
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A panel of experts convened by the FDA has overwhelmingly knocked back PTC Therapeutics’ filing for approval of ataluren.
EMA sounded the alarm after a staff survey found as few as 6% of its staff would move to some of the 19 cities vying to host it when it leaves London.
With a positive phase 3 trial in hand, Japan’s Daiichi Sankyo plans to file its essential hypertension therapy esaxerenone in its home market.
J&J is now assessing what it will take to quell the FDA’s concerns about the safety of the IL-6 monoclonal antibody before deciding on a path forward.
The clean sweep is a big win for Alnylam and the Sanofi-partnered RNAi drug, which is now set to be put before regulators at the end of the year.
The new FDA commissioner wants to target drug development costs as yet another study asks how much it really costs to make a medicine.