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
Privately-held, clinical-stage US biotech company Tarveda Therapeutics says that the proposed merger agreement with Organovo Holdings has been terminated following the emergence of unanticipated, late opposition to the proposed transaction by major Organovo stockholders. 8 April 2020
Privately-held US biotech EpiVax yesterday announced its partnership with GAIA Vaccine Foundation (GVF) to crowd-source funds for the COVID-19 project and its pledge to make a free license available to developing countries who qualify, in the context of this partnership. 8 April 2020
Germany’s Biotest and Swiss firm Octapharma have joined an alliance formed by CSL Behring, a unit of Australia’s CSL Limited, and Japan’s Takeda Pharmaceutical to develop a potential plasma-derived therapy for treating COVID-19. 7 April 2020
US RNAi therapeutics company Alnylam Pharmaceuticals has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO), in development for the treatment of primary hyperoxaluria type 1 (PH1). 7 April 2020
US biopharma company Millendo Therapeutics yesterday announced that it is discontinuing the development of livoletide as a potential treatment for Prader-Willi syndrome (PWS), a rare genetic condition. 7 April 2020
Bristol, UK-based Imophoron plans to begin pre-clinical tests on multiple COVID-19 vaccine candidates, together with the University of Bristol's COVID-19 Emergency Research (UNCOVER) Group. 7 April 2020
UK drug major GlaxoSmithKline is the latest to announce a link-up with Vir Biotechnology in search of coronavirus solutions, sending the latter’s share price up by nearly 20% during Monday morning. 6 April 2020
French company Polyplus-transfection is about to launch a new reagent that has been specifically developed to improve AAV (adeno-associated virus) production in suspension cell culture system for large-scale manufacturing. 6 April 2020
Following a positive opinion from the European Medicines Agency’s advisory body the CHMP in late February, Japanese pharma giant Takeda today announced that the European Commission has extended the current marketing authorization of Alunbrig (brigatinib). 6 April 2020
Gilead Sciences has announced a four-year collaboration with Second Genome, to identify biomarkers associated with clinical response in up to five of Gilead’s pipeline compounds. 6 April 2020
Oxford, UK-based biotech Izana Bioscience today announced the initiation of a two-center compassionate use study involving namilumab (IZN-101) in the treatment of patients with rapidly worsening COVID-19 in cooperation with the Humanitas research group. 6 April 2020
Samsung Biologics has entered into a strategic partnership with PharmAbcine for the development and manufacturing of oncology and neovascular candidate PMC-402. 6 April 2020
The US Food and Drug Administration has approved Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia failing an erythropoiesis stimulating agent. 6 April 2020
As the destructive power of COVID-19 skulks through the bourses of every continent, the first quarter of 2020 has delivered a punishing blow for investors in stocks of every stripe. 3 April 2020
Shares in Fate Therapeutics are up more than a tenth after the cellular immunotherapy specialist unveiled a global collaboration and option agreement with Johnson & Johnson. 3 April 2020
UK-based clinical-stage biotech Axon Neuroscience presented positive results of its Phase II trial for AADvac1, the first tau vaccine to treat and prevent Alzheimer's disease, at the AAT-AD/PD (International Conference on Alzheimer’s & Parkinson’s Diseases) 2020 conference, Vienna, Austria. 3 April 2020
The pivotal Phase III clinical trial results announced today show Dupixent (dupilumab) combined with standard-of-care topical corticosteroids (TCS) in children aged six-11 years with uncontrolled severe atopic dermatitis significantly improved disease signs, symptoms and health-related quality of life. 3 April 2020