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
Shares in Californian autoimmune specialist Annexon slumped over 40% on Wednesday, after the firm announced interim Phase II data for its Huntington’s disease candidate ANX005. 6 January 2022
Shares of US biotech Spectrum Pharmaceuticals closed down more than 11% at $1.27 yesterday, after it announced a strategic restructuring. 6 January 2022
Terms for a research and licensing collaboration between CRISPR company Intellia Therapeutics and privately-held cell therapy firm Kyverna Therapeutics have been agreed. 6 January 2022
US precision cancer therapy specialist Blueprint Medicines has appointed Kate Haviland to succeed Jeff Albers as chief executive (CEO), effective April 4, 2022. 6 January 2022
Californian precision oncology company Rain Therapeutics has announced a clinical supply agreement with Swiss pharma giant Roche for the supply of atezolizumab, the anti-PD-L1 monoclonal antibody marketed as Tecentriq. 5 January 2022
PhoreMost, a UK-based biopharma dedicated to developing drugs against intractable disease targets, has announced a collaboration to study oncology targets currently considered ‘undruggable’ with Polaris Quantum Biotech (POLARISqb), a North Carolina, USA-based quantum computing drug design company. 5 January 2022
Having taking the world by storm with their super successful COVID-19 vaccine Comirnaty, Germany’s BioNTech and US pharma giant Pfizer today announced the signing of a new collaboration agreement to develop an mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV). 5 January 2022
US biotech major Biogen has exercised its option to obtain an exclusive, royalty-bearing license to develop and commercialize BIIB115/ION306, from already partner Ionis Pharmaceuticals. 5 January 2022
USA-based Genocea Biosciences has entered into an R&D collaboration and option agreement with Janssen Biotech, part of US healthcare giant Johnson & Johnson, to explore the immunogenicity of neoantigens and the role and impact of Inhibigens in the context of vaccine therapies for cancer. 5 January 2022
Not only is there is a severe lack of effective T-cell lymphoma (TCL) treatments, according to GlobalData — a sentiment reflected by key opinion leaders (KOLs) — but the leading data and analytics company does not expect any significant solutions to appear in the next decade. 5 January 2022
Mergers and acquisitions among pharmaceutical and biotechnology companies announced in full year 2021 dropped to their lowest level in more than a decade, which may have been partly influenced by tougher regulations with competition authorities calling for significant divestments to green light deals. 4 January 2022
Denmark’s Genmab and privately-held Dutch biotech Synaffix have signed a license agreement providing Genmab broad access to Synaffix’ ADC technologies. 4 January 2022
Shares of PTC Therapeutics were up 6.9% to $42.58 by close of trading on Monday, ahead of formally announcing that Waylivra (volanesorsen) has successfully received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos - CMED (Drug Market Regulation Chamber) in Brazil. 4 January 2022
Privately-held Oncoheroes Biosciences is to acquire certain development rights to Allarity Therapeutics’ candidates dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and stenoparib, a PARP inhibitor. 4 January 2022
Shares of Swiss biotech Santhera Pharmaceuticals were up 15.4% at 1.50 Swiss francs by early afternoon, after it revealed an exclusive license agreement with China-based rare diseases specialist Sperogenix Therapeutics. 4 January 2022
Shares in New York-based rare disease firm Applied Therapeutics have fallen by a third, after the company said it would put a US regulatory bid on hold. 4 January 2022
US autoimmune drug developer Kyverna Therapeutics has entered into exclusive, worldwide licenses with the National Institutes of Health (NIH) for intellectual property related to a novel clinical-stage anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with properties uniquely suited for use in autoimmune diseases. 4 January 2022
South Korean Celltrion Group’s shares edged up 1.8% to 200,000 Korean won in early trading on Monday, after it released results for its COVID-19 cocktail therapy candidates including neutralization data against the Omicron variant. 4 January 2022