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
CSL Seqirus, a business of Australia's CSL, has announced positive efficacy data from a real-world evidence (RWE) study of influenza vaccines. 3 May 2024
California-based biopharma BridgeBio Pharma has announced the completion of a $200 million private financing of its former subsidiary, TheRas. 3 May 2024
Amgen has reported better-than-expected first quarter results, with simultaneous news from its obesity pipeline lifting the firm’s stock price by almost 15%. 3 May 2024
New Jersey, USA-based PDS Biotechnology today announced the appointment of Stephan Toutain, as chief operating officer (COO), effective as of May 1, 2024. 2 May 2024
San Diego, USA-based clinical-stage cell and gene therapy company Poseida Therapeutics saw its shares close up more than 20% at $2.92 yesterday, when it revealed a second collaboration with Japanese drug major Astellas Pharma. 2 May 2024
Sanofi’s Beyfortus (nirsevimab) reduced respiratory syncytial virus (RSV) hospitalizations by 82% in infants under six months of age, compared to babies who received no RSV intervention, according to the interim results of an ongoing study published in The Lancet. 2 May 2024
UK clinical-stage biotech Barinthus Biotherapeutics, formerly Vaccitech, today announced the appointment of Dr Leon Hooftman as chief medical officer (CMO). 1 May 2024
Californian biotech Enlaza Therapeutics has raised $100 million in a series A financing led by J.P. Morgan Asset Management’s Private Capital division. 1 May 2024
Japanese biotech PeptiDream edged up 3% to 2,081 yen today, after it announced an expansion of its peptide discovery collaboration with Swiss pharma giant Novartis. 1 May 2024
A new age of innovation in immunology could change medical practice and people’s lives, as long as all parts of the system learn, evolve and work together, writes Anant Murthy, General Manager, argenx EMEA, in an Expert View piece. 1 May 2024
UK-based developer of novel immunoglobulin E (IgE) antibodies to treat cancer, Epsilogen, has appointed Ashley Nagle as chief business officer (CBO) with immediate effect as part of a broader company expansion. 1 May 2024
The European Medicines Agency’s (EMA) Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign. 30 April 2024
On April 29, the US Food and Drug Administration granted traditional approval to Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. 30 April 2024