Agreement - December 20, 2021
Elicera enters agreement with Baylor College of Medicine
Elicera Therapeutics has signed an agreement with Baylor College of Medicine (BCM), Center for Cell & Gene Therapy regulating contract manufacturing of ELC-201, the company’s oncolytic virus armed with Elicera’s fully developed iTANK-platform for a multi-targeted attack on cancer. This is the second collaboration between Elicera and Baylor College of Medicine (BCM), Center for Cell […]
Biotech Business - December 16, 2021
FDA approves Calliditas’ TARPEYO
Calliditas Therapeutics has announced that the US Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. This indication is approved under accelerated approval. It has not been established […]
Biotech Business - December 14, 2021
Xbrane initiates development of two new biosimilar candidates
Xbrane Biopharma has announced the initiation of developing two new biosimilar candidates referencing Keytruda and Darzalex respectively. Together with the continued development of Xdivane, a biosimilar candidate referencing Opdivo, this forms an oncology biosimilar portfolio addressing 23 billion EUR of combined annual reference product sales, states the company. Keytruda and Darzalex biosimilars Keytruda is a […]
Biotech Business - December 3, 2021
Ultimovacs granted Orphan Drug Designation by FDA
Ultimovacs has announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) for the company’s universal cancer vaccine UV1 for the treatment of stage IIB – IV melanoma. UV1, as add-on therapy to checkpoint inhibitors ipilimumab and nivolumab, is currently being studied as first-line treatment for metastatic melanoma in a Phase […]
Agreement - November 23, 2021
Vaccibody becomes Nykode and enters agreement worth 900 MUSD
The new name and identity signifies a new phase of growth for the company and the agreement with US-based Regeneron is worth up to 900 million USD. The multi-target license and collaboration agreement with Regeneron includes five distinct programs, three within cancer and two within infectious diseases. Each of these may include several vaccine candidates, […]
Agreement - November 17, 2021
Affibody enters agreement with Acelyrin
Affibody has announced a partnership agreement with ACELYRIN to develop and commercialize izokibep, a bispecific molecule targeting interleukin-17A (IL-17), for multiple autoimmune diseases. Under the terms of the agreement, Affibody will receive a USD 25 million upfront payment and is eligible to receive up to USD 280 million in additional regulatory and sales milestones, plus […]