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
Nimble Therapeutics, a biotech spun out from Swiss pharma giant Roche in 2019, has expanded its collaboration and executed a license agreement with Genentech, a member of the Roche Group, for the discovery of peptide therapies for the treatment of diseases across multiple therapeutic areas. 6 January 2023
Chinese contract research, development and manufacturing organization WuXi Biologics has announced a license agreement with UK pharma major GSK. 6 January 2023
Armed with promising new data from the Phase III interim analysis, Japan’s largest drugmaker Takeda says it aims to seek marketing authorization for TAK-755 as the first recombinant ADAMTS13 (rADAMTS13) for a disorder with considerable unmet patient need. 6 January 2023
One of the pioneers of mRNA technologies, BioNTec, is investing the proceeds of its work during the pandemic on its original focus - cancer vaccines. 6 January 2023
The US Food and Drug Administration (FDA) yesterday accepted Biologics License Applications (BLAs) from Swiss pharma giant Roche and Belgium’s UCB, and granted them accelerated review. 6 January 2023
Adding to a deal with a US pharma giant last year, Cambridge, USA-based biotech Orna Therapeutics has now entered into a collaboration with Shanghai Xianbo Biotech, also known as Simnova outside of China, to discover, develop and commercialize multiple potential therapeutics in the area of oncology in China. 6 January 2023
One of the world’s leading specialists in mRNA therapeutics has partnered with California’s CytomX Therapeutics to create novel cancer meds. 6 January 2023
US immunology specialist Acelyrin has acquired ValenzaBio, a privately-held company developing therapies for autoimmune and inflammatory diseases, in an all-stock transaction. 5 January 2023
US precision medicines firm Frontier Medicines today announced the second and third programs under the company's global partnership with AbbVie have advanced into lead generation. 5 January 2023
Privately held Danish biotechnology company MinervaX has appointed Lidia Oostvogels as chief medical officer, bringing a wealth of experience in vaccine development with more than 25 years’ experience in clinical development. 5 January 2023
US biotech star-up Capsida Biotherapeutics has entered a multi-year strategic collaboration with pharma major Eli Lilly’s subsidiary Prevail to develop transformative genetic medicines for serious diseases. 5 January 2023
It has been a long road for Geron’s telomerase blocker, but the company is now finally planning a commercial launch for imetelstat in 2024. 5 January 2023
A report from industry commentator GlobalData highlights the potential for cell therapies to transform the treatment of multiple sclerosis (MS). 5 January 2023
UK pharma major AstraZeneca said today that its Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants. 5 January 2023
Taking advantage of the vast cash pile generated by the success of its COVID-19 vaccine Spikevax, US mRNA therapeutics and vaccines specialist Moderna (Nasdaq: MRNA) today announced its first out-right acquisition since its launch in 2020. 4 January 2023
Shares of US biotech firm Vera Therapeutics nose-dived in after-hours trading on Tuesday, after it announced what it described as “positive” the Phase IIb ORIGIN clinical trial of atacicept in patients with immunoglobulin A nephropathy (IgAN), which met its primary endpoint. 4 January 2023
Israeli biotech Chemomab Therapeutics has presented promising results on CM-101, its CCL24-neutralizing monoclonal antibody, in non-alcoholic steatohepatitis (NASH). 4 January 2023