Scrip spoke to Fred Martin, Vice President, Engineering & Product Management and Johannes Hoech, Vice President, Marketing & International Operations about current eClinical data challenges at the DIA Europe 2018 conference in Basel in April. Medrio is focused on eClinical technology with a unique approach to electronic data capture (EDC), protocol and site compliance support, and eSource data. Patient data stored in its software are in compliance with the EU General Data Protection Regulation (GDPR) that went into effect in May.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Takeda/Protagonist are awaiting 52-week data to confirm the results from the VERIFY trial of the drug in polycythemia vera.
Gilead chief medical officer Dietmar Berger said in an interview that the company plans to quickly take the results to regulators and foresees broad first-line use of the drug.
The drug boosted overall responses on top of the R-GemOx backbone, but the discussant pointed out that patients in waveLINE-003 were not very heavily pretreated.
