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
The life sciences landscape has adapted in tandem with data management solutions over the past several years, attracting significant investment. However, these solutions lack the ability to rapidly address and complement existing pain points and previous investments with the latest technological innovations. 3 January 2024
Shares of US neurogenetic focused biotech Voyager Therapeutics shot up 30% to $10.86 today, after it announced a capsid license agreement and strategic collaboration with Novartis. 2 January 2024
UK-based biotech Sareum Holdings saw its shares gain 18% to 70.00 pence by early afternoon after it announced that is co-development partner, the CRT Pioneer Fund (CPF), has entered into a development and commercialization licence agreement for SRA737 with a private biopharma company based in the USA. 2 January 2024
After decades without a breakthrough, scientists targeting the respiratory syncytial virus (RSV) have notched up three successes in a period of around a year. 2 January 2024
British and American biotech Apollo Therapeutics has boosted its series C financing round by $33.5 million, bringing the total amount to $260 million. 2 January 2024
South Korean biotech LegoChem Biosciences has entered into a license agreement with Janssen Biotech, to develop and commercialize LCB84. 29 December 2023
US biotech Iovance Biotherapeutics saw its shares drop more than 20% on Tuesday, after it revealed a setback with its clinical program for LN-145 TIL therapy in non-small lung cancer (NSCLC). 29 December 2023
US oncology drug developer Oncternal Therapeutics took a 10% initial tumble after it revealed a patient in an early-stage trial of its ONCT-808, but closed the day up 18% at $0.59. 29 December 2023
Singapore-based Novotech, an Asia-Pacific-focused contract research organization (CRO), has presented research on financial shifts in the biotech industry in 2023. 29 December 2023
Vertex Pharmaceuticals and CRISPR Therapeutics made history last month by gaining approval for the first CRISPR-based drug, Casgevy (exagamglogene autotemcel). 29 December 2023
Just a few days after punting $14 billion to acquire Karuna, Bristol Myers Squibb has announced a definitive agreement to take over radiopharmaceuticals-focused drug developer RayzeBio. 28 December 2023
Privately-held Chinese firm Elpiscience Biopharma has inked a deal with Japan’s Astellas Pharma related to two novel bi-specific macrophage engagers (BiME). 28 December 2023
Chinese biopharma Innovent Biologics and Xuanzhu Biopharma have entered into a clinical trial collaboration and supply accord for the combination therapies of Tyvyt (sintilimab) injection with KM-501. 28 December 2023
The level of competition in the Russian pharmaceutical market will significantly tighten next year, as local drugmakers plan to overtake global producers in the segment of public procurements, reports The Pharma Letter’s local correspondent. 28 December 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the advanced melanoma medicine Opdualag (nivolumab-relatlimab) for patients from the age of 12. 28 December 2023
Shares in US muscle biology specialist Cytokinetics soared 70% to $77.34 this morning, as it announced positive results from the much-awaited SEQUOIA trial of its aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). 27 December 2023
Japan’s innovative pharma market has been on an upwards trajectory these last 12 months – despite what you may have seen in IQVIA thought leadership reports, industry advocacy body pronouncements or USD-reported results. 27 December 2023