The first part of Aldeyra’s Phase III RENEW study of the aldehyde trap candidate, reproxalap, shows positive effects on one of two co-primary endpoints and indicates an induction-maintenance dosing regimen should be used in part 2 of the study, expected to start in the first half of next year.
Aldeyra Therapeutics Inc. has presented mixed top-line results from part 1 of its adaptive Phase III RENEW study of the potential first-in-class dry eye disease therapy, reproxalap, and investors have reacted cautiously to the data.
The Lexington, MA-based biotech’s share price on NASDAQ declined by 32% on 3 December to $5
Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.
Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.
The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.
But differences in trial design means it is hard to handicap GSK’s product against Mirum’s volixibat.
Mid-sized Japanese pharma firm to acquire tobacco giant’s pharma operations and take private the listed Torii Pharmaceutical business, in bid to build sales reach and strengthen manufacturing.
The US FDA has ordered compounders of the Danish firm's obesity drug semaglutide to shut up shop later this month, but competition from Eli Lilly is only increasing.
Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.
