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
China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. 10 January 2024
New York-based TG Therapeutics has entered into an agreement with Precision BioSciences related to an allogeneic CD19 CAR-T cell therapy. 10 January 2024
Blueprint Medicines Corporation has outlined its 2024 corporate strategy, promising accelerated revenue growth, sustainable research and development, and a clear path to profitability. 9 January 2024
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of Tivdak (tisotumab vedotin-tftv) to full approval. 9 January 2024
UK pharma major GSK has entered into an agreement to acquire Anglo-American biotech Aiolos Bio, a clinical-stage company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions. 9 January 2024
Japanese drugmaker Astellas has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for zolbetuximab. 9 January 2024
US pharma giant Merck & Co entered into a definitive agreement under which Merck, through a subsidiary, will acquire Harpoon Therapeutics for $23.00 per share. 9 January 2024
Breaking new ground, private Chinese start-up Argo Biopharmaceutical has won two exclusive license and collaboration contracts with Swiss cancer giant Novartis. 9 January 2024
The European Commission (EC) has approved US pharma giant Pfizer’s Talzenna (talazoparib) in combination with Xtandi (enzalutamide), for the treatment of adult patients with metastatic castration-resistant 9 January 2024
USA-based biotech incubator Flagship Pioneering and South Korea’s Samsung today announced a collaboration aimed at fostering cutting-edge biopharmaceutical innovation. 8 January 2024
Shares of UK blood disease drug developer Hemogenyx Pharmaceuticals were down 7.5% at 2.13 pence as trading drew to a closed today, despite announcing the successful completion of its Process Qualification (PQ) run of the end-to-end process for the manufacture of HEMO-CAR-T cells. 8 January 2024
Kicking of the JP Morgan Healthcare conference this morning, Johnson & Johnson announced a definitive agreement to acquire Ambrx Biopharma. 8 January 2024
Germany’s Boehringer Ingelheim closed last week with a fourth licensing deal, this one with Japan’s Kyowa Kirin to develop a novel, first-in-class treatment for fibro-inflammatory diseases. 8 January 2024
Belgium’s UCB has won European Commission (EC) approval for Rystiggo (rozanolixizumab) as an add-on to standard therapy for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. 8 January 2024
Swiss pharma giant Novartis has entered an agreement to acquire Dutch firm Calypso Biotech, a developer of Interleukin15 (IL-15) targeted therapies. 8 January 2024
Two Finnish companies, Orion Corporation and Glykos Finland Oy, have entered into a research collaboration and licensing agreement related to the development of antibody-drug conjugates (ADCs) to treat solid tumors. 8 January 2024
Swiss pharma giant Novartis today announced positive results from the primary analysis of ASC4FIRST, a pivotal Phase III trial comparing Scemblix (asciminib) with investigators’ choice of tyrosine kinase inhibitor (TKI) treatment in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 8 January 2024