Biotech Business - January 14, 2025
FDA accepts BioArctic’s partner Eisai’s BLA for subcutaneous maintenance dosing of Leqembi in the US
The U.S. Food and Drug Administration (FDA) has accepted BioArctic’s partner Eisai’s Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing.
Biotech Business - January 13, 2025
Elicera’s drug candidate receives Orphan Drug Designation in the US
Elicera Therapeutics' drug candidate ELC-100 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic neuroendocrine tumors.
Biotech Business - December 16, 2024
Medivir obtains IND approval for fostrox
Medivir has announced the approval of the US Investigational New Drug application (IND) for evaluating fostrox + Lenvima vs Lenvima alone in a phase 2b study in 2nd line advanced HCC.
Biotech Business - December 13, 2024
EXACT Therapeutics raises NOK 145 million
The company is preparing to launch a phase II clinical trial in pancreatic cancer with funds from a recent private placement.
Biotech Business - December 10, 2024
NEOGAP Therapeutics receives EMA’s ATMP classification
The European Medicines Agency (EMA) has granted Advanced Therapy Medicinal Product (ATMP) classification to NEOGAP's cell therapy, pTTL (personalized Tumor Trained Lymphocytes).
Biotech Business - December 9, 2024
MetaCurUm secures SEK 1 million grant
MetaCurUm has been awarded SEK 1 million from the Swedish Innovation Agency, Vinnova, under the "Acceleration of Deeptech Companies 2024" initiative.
