Oncorena receives FDA approval to initiate studies in the US

The Board of Directors of Flerie and the Board of Directors of Toleranzia have adopted a plan to join forces through a statutory merger between the companies in accordance with the Swedish Companies Act.

Immunovia has announced additional results from the VERIFI study of its next-generation pancreatic cancer test, strengthening the company’s position as it prepares to launch the pancreatic cancer blood test commercially. 

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to HLX22 (AC101), an anti-HER2 monoclonal antibody, for the treatment of gastric cancer.

Xbrane Biopharma has entered into an agreement to sell XB003 (biosimilar candidate to Cimzia) and parts of its organization, including approximately 40 employees and laboratory equipment, to Alvotech for a total consideration of approximately SEK 275 million.

The US FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation (ODD) to exidavnemab for the treatment of Multiple System Atrophy (MSA), providing incentives for the development of treatments for rare diseases with a high medical need.

The company has announced the authorization of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state.

This collaboration aims to advance the discovery and development of new therapeutic solutions targeting G protein-coupled receptors (GPCRs), ion channels, transporters and other integral membrane proteins in therapeutic areas such as mental health and cardio-renal-metabolic diseases.