BioSpace News Archive

Less than two years after launch, the startup posts positive Phase II results and heads into Phase III trials for major depressive disorder with a new CEO.

Following the full approval of Leqembi, the CMS suggests expanding its coverage of beta-amyloid PET scans, which could improve the uptake of novel Alzheimer’s disease treatments.

The Netherlands-based immunology company said Wednesday it brought in $1.1 billion by selling more than two million shares in the U.S. and Europe.

Next-gen biomanufacturers are particularly susceptible to the challenges inherent in manufacturing cell and gene therapies, risking getting derailed by unexpected costs for already-tight budgets.

The company also terminated a Phase III trial of its TGFB inhibitor as a treatment for metastatic pancreatic ductal adenocarcinoma, though that drug will continue to be tested as a treatment for colorectal cancer.

Tuesday’s partnership will dig into Flagship’s deep ecosystem of companies and technologies to discover medicines in line with Pfizer’s core strategic areas.

Virax Biolabs Group Limited, an innovative diagnostics company focused on the detection of immune responses and diagnosis of viral diseases, announced that it has signed contracts to launch two new research and laboratory facilities in the United Kingdom.

Revolo Biotherapeutics today announced additional data from its proof of concept, 2-week, 3-dose, Phase 2a clinical trial evaluating the efficacy, safety, and tolerability of the company’s immune-resetting drug, ‘1104, in adults with active eosinophilic esophagitis (EoE).

Advent Therapeutics, Inc. has been awarded a $3 million National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Phase IIB grant.

Akebia Therapeutics today announced that Akebia completed an End of Dispute Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss Akebia’s forthcoming resubmission of its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis.