Biotech Business - June 27, 2023
Xbrane announce US FDA filing acceptance
The company has announced the acceptance of the supplemental Biologics License Application (sBLA) for a Lucentis (ranibizumab) biosimilar candidate by the US Food and Drug Administration. The regulatory process can therefore be initiated with a Biosimilar User Fee Amendment (BsUFA) goal date of April 21st, 2024, states the company. “Today’s sBLA acceptance marks an important […]
Acquisition - June 26, 2023
Sobi completes acquisition of CTI BioPharma
Swedish Orphan Biovitrum and CTI BioPharma have announced the completion of the acquisition of CTI by Sobi through its indirect wholly owned subsidiary Cleopatra Acquisition Corp (Cleopatra). Following the completion of Sobi’s successful tender offer to purchase all outstanding shares of common stock of CTI for USD 9.10 per share in cash, net to the […]
Biotech Business - June 20, 2023
Mendus receives ATMP certificate from the EMA
The company has been granted an Advanced Therapy Medicinal Product (ATMP) certificate following a review of manufacturing quality and non-clinical data for its lead pipeline program vididencel by the European Medicines Agency (EMA). Although this certification is not a requirement for a future application for marketing authorization, it affirms that manufacturing quality and non-clinical development […]
Biotech Business - June 13, 2023
FDA confirm clinical benefit of BioArctic’s LEQEMBI
The FDA Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from the Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI 100 mg/mL intravenous injection for the treatment of Alzheimer’s disease. LEQEMBI received Accelerated approval from the FDA for the treatment of early Alzheimer’s disease on […]
Biotech Business - June 12, 2023
GutCRINE – First investment from the University of Copenhagen’s new investment company
The University of Copenhagen is the first Danish university to invest in a company based on its own research in unique collaboration with a venture fund. On April 11th 2023, the company GutCRINE ApS received an initial financing of 4 million DKK to begin development of a completely new class of biological medicines, so-called pharmabiotics. […]
Biotech Business - June 12, 2023
Novo Nordisk invests 15.9 billion DKK in expansion of manufacturing facilities
The company will invest 15.9 billion DKK starting in 2023 to expand an existing Active Pharmaceutical Ingredient (API) production facility in Denmark for the future portfolio within serious chronic diseases. The investment in Hillerød will create additional production capacity and increase Novo Nordisk’s ability to meet future market demands and be a key enabler for […]
