Gilead and Galapagos are ending all studies of an experimental drug for lung disease after independent reviewers determined its benefits do not outweigh the risks.
The decision to end research on ziritaxestat, which was being tested as a treatment for idiopathic pulmonary fibrosis, marks a second major failure for the Gilead-Galapagos partnership. In August, the Food and Drug Administration unexpectedly rejected filgotinib, a rheumatoid arthritis drug that was central to the 10-year, $5 billion pact the companies inked in mid-2019.
Galapagos and Gilead didn’t provide details of the issues with ziritaxestat in a Wednesday release. Rather, they said data would be presented at future medical meetings. The monitoring board acted in part because of mortality trends observed among patients, Mizuho Securities analyst Salim Syed wrote in a note to investors, citing a statement he received from Gilead. Galapagos shares tumbled 18% Wednesday. READ MORE
by Kristin Jensen
This year has already witnessed a handful of memorable FDA approvals. But the race isn’t over yet. Looking to close out 2021 with FDA approvals stand four potential blockbusters from the likes of Argenx, UCB, Pfizer and Roche, according to Evaluate Pharma. Those meds combined are worth roughly $7.1 billion in sales cumulatively by 2026, according to Evaluate’s estimates.
Getting started is often the most difficult part—and that’s especially true in rare diseases and diagnoses. Patients and families often spend many years searching for their diagnosis starting point. For Horizon Therapeutics’ first innovation challenge, it took that struggle to heart and asked for technology-based rare disease solutions that result in faster or more accurate diagnoses.
Researchers from the Quadram Institute and the University of East Anglia (UEA) discovered that treating mice with broad-spectrum antibiotics increased the rate at which their breast cancer tumours grew.