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A new House bill aims to build on the success of the Generating Antibiotics Incentives Now (GAIN) Act by allowing drugmakers to submit less data for antibiotics and antifungals that affect limited patient populations. Read More
A new House bill aims to build on the success of the Generating Antibiotics Now (GAIN) Act by allowing drugmakers to submit less data for antibiotics and antifungals that affect limited patient populations. Read More
In a boost for big pharma, the European Medicines Agency raised the fee-reduction rate for non-small and medium-sized enterprises seeking assistance on adult-only protocol from 40 percent to 75 percent, effective Jan. 1. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More
Eli Lilly’s plans for strong sales growth in 2014 have been set back, with the drugmaker saying Thursday its promising depression treatment edivoxetine has failed in late-stage testing. Read More
While developers of next-generation heart drugs known as PCSK9 inhibitors will need to present data showing their effectiveness at lowering cholesterol, blood pressure and inflammation, they will not be required to show reduced heart attack or stroke, according to the FDA. Read More
The biggest hurdle when trial investigators and staff are trying to build a good relationship with a study participant is managing their expectations, experts say. But there are some basic tips sites can use to overcome those hurdles. Read More
The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have agreed to work together to help regulators and drug sponsors make the most of clinical and postmarket health data. Read More