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
AbbVie yesterday announced positive top-line results from the first of two studies of the Phase III SELECT-AXIS 2 clinical trial evaluating the efficacy and safety of Rinvoq (upadacitinib; 15mg, once daily) in patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic DMARD therapy. 8 October 2021
Shares of US clinical-stage biotech Allogene Therapeutics plunged more than 40% in after-hours trading yesterday, following its revelation of a Food and Drug Administration hold on the company’s AlloCAR T clinical trials. 8 October 2021
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics and US drug developer Enzolytics have signed a strategic CDMO partnership agreement. 7 October 2021
Canada-based ImmunoPrecise Antibodies (TSX Venture: IPA) and French drugmaker Pierre Fabre today announced that IPA's subsidiary, Talem Therapeutics and Pierre Fabre have entered a multi-year, multi-target research collaboration with the goal to discover and develop therapeutics antibodies for up to nine targets. 7 October 2021
Neumora Therapeutics, a US clinical-stage biotech focussed on brain diseases through the integration of data science and neuroscience, announced its launch today. 7 October 2021
Privately-held Danish vaccines company MinervaX has provided an update on clinical progress and announced changes to its executive and scientific advisory boards. 7 October 2021
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older with inadequate response to existing therapies. 7 October 2021
The value of US gene therapy company Voyager Therapeutics doubled in Wednesday’s early trading following news of a deal with the world’s largest pharma company. 6 October 2021
US clinical-stage biotech Pieris Pharmaceuticals (Nasdaq: PIRS) today announced the promotions of Thomas Bures to chief financial officer and Ahmed Mousa to chief business officer. 6 October 2021
Johnson & Johnson has announced a new analysis of Stelara (ustekinumab), using safety data from 13 clinical studies across approved indications. 6 October 2021
Healthcare giant Johnson & Johnson has submitted data to the US Food and Drug Administration (FDA) to support use of a booster shot of its COVID-19 vaccine in adults. 6 October 2021
New research conducted by Pfizer and published in The Lancet shows effectiveness of the firm’s coronavirus jab waning over time, although not due to the Delta variant of the virus. 6 October 2021
German family-owned drug major Boehringer Ingelheim today inaugurated its state-of-the-art biopharmaceutical production facility Large Scale Cell Culture (LSCC) in Vienna, Austria. 6 October 2021
USA-based microbiome company Vedanta Biosciences says that its Phase II clinical trial of VE303, an orally administered investigational live biotherapeutic product in development for the prevention of recurrent Clostridium difficile infection (CDI) in high-risk patients, met its primary endpoint of preventing disease recurrence through Week 8. 6 October 2021
Australia’s Therapeutic Goods Administration (TGA) has granted provisional determination to the local subsidiary of US pharma giant Pfizer in relation to a new combination therapy containing PF-07321332 and ritonavir, for the treatment of adult patients with symptomatic, confirmed coronavirus infection. 6 October 2021
For the first time in 20 years, a new therapy for sickle cell disease is to be made available on the UK's National Health Service (NHS). 5 October 2021
Ireland-headquartered biotech Horizon Therapeutics has announced the publication of a post-hoc analysis from the N-MOmentum Phase II/III pivotal trial of Uplizna (inebilizumab-cdon), which highlights a sustained effect on attack risk with no new safety signals in people with neuromyelitis optica spectrum disorder (NMOSD) who received the treatment for four or more years. 5 October 2021
US biotech Xencor saw its shares gain 5.5% by close of trading and a further 2% to $36.23 after hours, following its revelation of a second deal with US health care giant Johnson & Johnson. 5 October 2021
UK pharma major AstraZeneca has submitted a request to the US Food and Drug Administration for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19. 5 October 2021