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
Japanese drugmaker Eisai today announced it is ending its global strategic collaboration with Bristol Myers Squibb for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC). 1 July 2024
Specialty vaccine company Valneva has announced that the European Commission (EC) has granted marketing authorization for its single-dose vaccine, Ixchig, for the prevention of disease caused by the chikungunya virus in people aged 18 years of and older. 1 July 2024
AstraZeneca’s Marketing Authorization Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. 1 July 2024
Late-stage US biotech Rocket Pharmaceutical’s shares slumped 12.5% in pre-market activity, but closed down just 2% at $21.10 on Friday after it announced a setback regarding approval of its gene therapy Kresladi (marnetegragene autotemcel; marne-cel). 29 June 2024
Johnson & Johnson (NYSE: JNJ) has received a new European approval for a combination of Rybrevant (amivantamab) plus chemotherapy in lung cancer. 28 June 2024
Japanese drugmaker Eisai and US biotech Biogen (announced that their humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) has been launched in China. 28 June 2024
US biotech 2seventy bio yesterday announced the completion of an asset purchase agreement (APA) by Danish diabetes and obesity giant Novo Nordisk. 28 June 2024
TwoStep Therapeutics, a biotech start-up developing targeted therapies for solid tumors, has officially launched after securing $6.5 million in seed funding. 27 June 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of patritumab deruxtecan (HER3-DXd). 27 June 2024
It was a milestone achievement when Moderna last month announced its first US Food and Drug Administration (FDA) approval outside COVID-19. 27 June 2024
The UK’s health technology assessor has changed its tune regarding CSL Behring’s Hemgenix (etranacogene dezaparvovec), recommending the product for use in England and Wales. 27 June 2024
US RNA specialist Wave Life Sciences has presented positive results from its Phase Ib/IIa SELECT-HD trial of WVE-003, which is being developed as a potential disease modifying therapeutic for Huntington’s disease (HD). 26 June 2024