Research & Development

But differences in trial design means it is hard to handicap GSK’s product against Mirum’s volixibat.

The company is trading below cash after admitting that an adverse event in a Rett syndrome trial left a patient critically ill.

Interim results from an international Phase II study with its prolactin inhibiting antibody have boosted HopeMed’s confidence in its first-line potential in the chronic disorder, the Chinese venture's CEO tells Scrip.

Questions from researchers and public health advocates during workshop to discuss FDA authority under PREA Act point to agency and OTC NDA sponsors having additional boxes to check on potential unmet needs in drugs indicated for children and specifically on clarity of labeling for consumers of low health literacy, narrowing indications to prevent confusion and education about OTC drug formulations for health care providers.

While Europe and the US had similar levels of R&D expenditure until 2014, the gap is widening and China is coming up on the rails, according to a new report from EFPIA, which warns that a coherent life sciences strategy for Europe would help stop the decline.

The roadmap sets out eight steps to help registry teams link data from registry records with administrative health services data.

Novel targets for managing inflammation hold the promise of greater efficacy and safety for diseases not widely viewed as inflammatory in nature.

Pimicotinib’s Phase III data in tenosynovial giant cell tumor are better than its rivals but the fight for a small number of patients will be fierce.

At a recent conference, executives from Boehringer and Amgen laid out their expectations for the future of obesity and how they intend to navigate the changes.

Dreams of a future with early curative treatments drives wave of drug development in pre-surgical and perioperative treatment in many tumor types.