Gilead has been trying to construct a deeper NASH pipeline as prospects dim for its lead candidate in the space. Phase 3 data released in February showed the candidate, selonsertib, didn’t significantly outperform placebo in treating NASH patients who developed compensated cirrhosis because of severe liver scarring. While another trial evaluating the drug in less sick patients has
Researchers have discovered that a blood-thinning drug, dabigatran, can significantly reduce the risk of death, heart attack, stroke, and other heart or blood-vessel complications in patients who have a heart injury following major, non-cardiac surgery. Every year, around eight million people in the world develop a condition called myocardial injury after non-cardiac surgery (MINS), which
Swedish Biopharmaceutical company, Swedish Orphan Biovitrum AB has announced that the FDA has issued a “study may proceed” letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003 for the treatment of mucopolysaccharidosis type IIIA. In addition, SOBI003 was granted Fast Track status by the
Doctors at Children’s Hospital Colorado are hoping to launch as many as 25 new clinical trials in the next six months following a recently signed federal law opened the floodgates to test experimental cancer drugs for children. “The paediatric oncology community is really excited,” said Dr. Lia Gore, the director of Children’s Center for Cancer
Roche is doubling down on its anti-amyloid beta antibody crenezumab by starting a second phase 3 trial in patients with prodromal to mild Alzheimer’s disease after getting a look at binding, dose escalation and drug-disease progression model data late last year. A phase 2 trial of crenezumab, which Roche’s Genentech licensed from AC Immune in
Clinical data gathered for Sandoz’s biosimilar Etanercept (derived from Amgen and Pfizer’s Enbrel) was based from a “landmark” trial design in psoriasis in which over 500 patients switched from the original drug to the biosimilar. The data from the EGALITY trial showed the Novartis unit’s biosimilar, filed in the US and EU, met primary endpoint
In recognition of International Clinical Trials day, Clinical Professionals invites Deborah Bruce, Training Academy Manager, to provide some personal insight and reflect on the importance of clinical trials. As today is International Clinical Trials Day, which marks the anniversary of the first clinical trial by James Lind in 1747, I find myself reflecting on my
