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
Germany-based Medigene’s shares were down 3.7% at 1.04 euros in late afternoon trading, after it revealed a collaboration with China’s WuXi Biologics. 8 August 2024
Vertex Pharmaceuticalsrevealed a reimbursement agreement with NHS England for eligible transfusion-dependent beta thalassemia (TDT) patients to access the CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel), from today. 8 August 2024
US cell and gene therapy company Precigen has announced a strategic reprioritization of the company's clinical portfolio and streamlining of resources. 8 August 2024
Takeda announced that the European Commission (EC) has approved Adzynma (apadamtase alfa/cinaxadamtase alfa; code name TAK-755) for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP). 8 August 2024
Finland-based Faron Pharmaceuticals, a biopharma reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, has announced that its chief executive Markku Jalkanen is to retire. 7 August 2024
Shares of US therapeutic gene editing company Sangamo Therapeutics leapt as much as 46% to $1.11 yesterday on the news of a licensing deal. 7 August 2024
Tuesday was a good day for Levicept, a UK biotech focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis and other pain indications. 7 August 2024
US biotech major Amgen reported second quarter 2024 financial results late yesterday, showing total revenues increased 20% to $8.4 billion in comparison to the like quarter of 2023. 7 August 2024
US clinical-stage biotech Equillium saw its shares rise 8% to $0.68 as it revealed progress with its first-in-class anti-CD6 monoclonal antibody. 6 August 2024
Daiichi Sankyo (and US pharma giant Merck & Co have expanded their existing global co-development and co-commercialization agreement to include Merck’s MK-6070. 6 August 2024
The US subsidiary of Swiss family-owned protein specialist Octapharma today revealed that the US Food and Drug Administration (FDA) has expanded the approval of fibryga, fibrinogen (human) lyophilized powder for reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD). 6 August 2024
Shares of Swiss antibody drug conjugates (ADCs) develop ADC Therapeutics were down more than 11% at $2.55 as it reported financial results for 2nd-qtr 2024 and provided operational updates. 6 August 2024
Actinium Pharmaceuticals’ shares closed down 60% yesterday and fell a further 10% to $2.23 in after-hours trading, when the company announced a regulatory setback for its Iead candidate. 6 August 2024
California’s BioMarin Pharmaceutical (Nasdaq: BMRN) has announced a strategic pivot for its Roctavian (valoctocogene roxaparvovec-rvox) business, focusing on the USA, Germany, and Italy. 6 August 2024