GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Japan’s Eisai and US biotech Biogen today revealed that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) for the treatment of Alzheimer’s disease (AD). 14 August 2024
US clinical stage caner drug developer Theriva Biologics revealed that the US Food and Drug Administration (FDA) has granted Rare Pediatric Drug designation (RPDD) for VCN-01 for the treatment of retinoblastoma. 1 August 2024
Eisai and Biogen have announced that Israel has approved their Alzheimer's treatment, Leqembi (lecanemab), adding to nods in the USA, Japan, China, South Korea, and Hong Kong. 12 July 2024
Contract research and development organization (CDMO) Emergent BioSolutions has announced that Johnson & Johnson will pay $50 million to resolve claims linked to a terminated manufacturing deal for the latter’s COVID-19 vaccine. 11 July 2024
Japan’s Eisai and US biotech Biogen have announced that the Department of Health in Hong Kong has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for treatment of Alzheimer’s disease (AD). 11 July 2024
PolTREG, a Polish biotech developing cell therapies for autoimmune diseases, has announced that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care. 24 June 2024
Indian drugmaker Cipla announced that its wholly-owned subsidiary in the UK, Cipla (EU) Limited, will invest an additional 3 million euros ($3.2 million) in Ethris GmbH, a German firm delivering mRNAs directly to the respiratory system. 19 June 2024
Dutch autoimmune diseases specialist Argenx announced that results from the Phase II ALPHA study of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) show that treated patients had no clinically meaningful improvement compared to placebo on the total Malmö POTS symptom (MaPS) score and COMPASS31. 17 June 2024
The US Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. 10 June 2024
The European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) from Gilead Sciences’ Kite subsidiary. 6 June 2024
The European Commission has granted marketing authorization for Altuvoct (efanesoctocog alfa), for the treatment and prevention of bleeds and perioperative prophylaxis in hemophilia A. 19 June 2024
Chicago, USA-based biopharma giant AbbVie has picked up a new nod for Skyrizi (risankizumab-rzaa), for adults with moderately to severely active ulcerative colitis. 19 June 2024
Third Rock incubated clinical-stage biotech Marea Therapeutics launched yesterday with $190 million in combined Series A and B financings. 19 June 2024
Boston, USA-based biotech start-up Ascidian Therapeutics yesterday announced a research collaboration and licensing agreement with Roche for the discovery and development of RNA exon editing therapeutics targeting neurological diseases, adding to the Swiss pharma giant’s plethora of RNA alliances. 19 June 2024
The private biotech sector witnessed a 46% increase in total venture financing deal value in the first quarter of 2024 compared to the fourth quarter of 2023. 19 June 2024
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Capvaxive (pneumococcal 21-valent conjugate vaccine), submitted by US pharma giant Merck & Co. 18 June 2024
US biotech Arvinas has promoted Ian Taylor to president of R&D. Angela Cacace will take over from Dr Taylor in his current role of chief scientific officer. 18 June 2024
Johnson & Johnson has announced that its drug nipocalimab demonstrated statistically significant and clinically meaningful improvements in a Phase II study for Sjögren’s disease (SjD). 18 June 2024
US liver disease focused biotech Mirum Pharmaceuticals (Nasdaq: MIRM) saw its shares leap 15.4% to $29.90 by close of trading on Monday, as it reported interim results from two Phase IIb studies evaluating volixibat. 18 June 2024
Elion Therapeutics, a biotechnology company focusing on invasive fungal infections, has announced the successful closing of an $81 million series B funding round. 17 June 2024
New data has laid bare the reasons why US biotech Gilead Sciences has given up on magrolimab, a monoclonal antibody that targets CD47, an antiphagocytic signal present on cancer cells. 17 June 2024
German biotech BioNTech today announced that it has been informed by its partner, China’s MediLink Therapeutics (Suzhou), that the US Food and Drug Administration (FDA) has placed a partial clinical hold on a trial of their antibody-drug conjugate (ADC). 17 June 2024
London, UK-based Syncona has announced that Freeline Therapeutics has acquired SwanBio Therapeutics to create a new company, Spur Therapeutics. 17 June 2024
Ophthalmology specialist Ocular Therapeutix has highlighted impressive clinical development progress with Axpali (axitinib intravitreal implant) for wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) at an investor day. 17 June 2024
Boston, USA-based Vertex Pharmaceuticals has announced longer-term data for Casgevy (exagamglogene autotemcel [exa-cel]) from global clinical trials in people with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). 17 June 2024