Biotech Business - October 10, 2023
Cellevate raises 39 million SEK
Cellevate has announced the closure of its recent investment round, securing a total of 39 million SEK. The round was led by Industrifonden, in syndication with the European Innovation Council Fund (EIC Fund) and Onsight Ventures. “We are thrilled to have gained tremendous support from such a strong syndicate of investors, who share our vision […]
Biotech Business - October 2, 2023
New company aims to redefine cell therapy development
Alder Therapeutics is a newly founded preclinical phase stem cell therapy development company with the goal to reshape the cell therapy sector with a novel, reduced-risk approach and two cell therapy candidates for diseases with high unmet need. Alder Therapeutics was formed in 2022 to unlock the benefits of PSCs for patients across the world, […]
Biotech Business - September 27, 2023
Abera collaborates with strategic investors and executes a directed share issue
Abera Bioscience begins cooperation with three strategic investors and in connection with this, the board has decided to carry out a directed new share issue of 1,555,556 shares at a subscription price of SEK 3.60 per share, which adds to the company SEK 5.6 million before issue costs. The three strategic investors are Gunnar Sachs […]
Biotech Business - September 26, 2023
Genmab receives European Commission approval
The European Commission has granted conditional marketing authorization for TEPKINLY as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in […]
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 […]
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 […]
