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
Positive Phase II clinical trial demonstrated frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis (MS). 15 February 2024
US biopharma Citius Pharmaceuticals has announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Lymphir (denileukin diftitox) for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. 15 February 2024
US biotech Cogent Biosciences saw its shares close up a massive 59.3% at $8.70 yesterday, after it announced a securities purchase agreement for a private investment in public equity financing 15 February 2024
Tesaro, a subsidiary of UK pharma major GSK, has come up on top in the latest stage of its legal battle with Anglo-Swedish drugmaker AstraZeneca regarding the ovarian cancer drug Zejula (niraparib). 15 February 2024
Japan’s Ono Pharmaceutical yesterday revealed that it has entered into an option and collaboration agreement with Swiss biotech Numab Therapeutics. 15 February 2024
French pharma major Sanofi is angry that its interleukin (IL)-13 and IL-4 blocking antibody Dupixent (dupilumab) has been recommended for the treatment of moderate-to-severe prurigo nodularis (PN) in Scotland but not in England and Wales. 14 February 2024
After four years in stealth, California, USA-based biotech Latigo Biotherapeutics today announced its emergence with a $135 million Series A financing. 14 February 2024
The US Food and Drug Administration (FDA) has extended the Priority Review period for the Biologics License Application (BLA) for Kresladi (marnetegragene autotemcel; formerly RP-L201) for severe leukocyte adhesion deficiency-I (LAD-I). 14 February 2024
China-based biotech Brii Biosciences has entered into a second agreement with VBI Vaccines, sending the US firm’s up almost 10% to $0.72 in pre-market activity. 14 February 2024
Leading Australian biotech CSL Limited has reported financial results for the six months to December 31, 2023, showing that revenue came in at A$8.05 billion ($12.3 billion, up 11% at constant currency (CC). 14 February 2024
Clinical stage gene therapy company MeiraGTx Holdings announced the achievement of the first milestone under the asset purchase agreement with Janssen Pharmaceuticals. 14 February 2024
Shares of Canadian clinical-stage precision oncology company Repare Therapeutics leapt 10% to $7.57 today, as it revealed that Swiss pharma major Roche was returning rights to a partnered product. 13 February 2024
Privately-held French biotech StromaCare, which is developing immunotherapies through stroma modulation, today announced the appointment of Georges Rawadi as chief executive (CEO). 13 February 2024
Japanese drugmaker Ono Pharmaceutical has entered into a drug discovery collaboration and option agreement with USA-based Shattuck Labs to generate bifunctional fusion proteins for pathways involved in autoimmune and inflammatory diseases. 13 February 2024
Australian biotech CSL Limited yesterday announced disappointing top-line results from its Phase III AEGIS-II trial, with the news sending the firm’s shares down as much as 5%, wiping A$7 billion off its market capitalization. 13 February 2024
Rare diseases specialist Swedish Orphan Biovitrum (also known as Sobi) has set up a joint venture with South Korean firm Handok to commercialize its drugs in the latter’s home market. 13 February 2024
Genetic disease company Vertex Pharmaceuticals has secured conditional marketing authorization for Casgevy (exagamglogene autotemcel) in Europe. 13 February 2024
Sana Biotechnology has announced it has raised $165 million in a public offering, with Morgan Stanley, JP Morgan and Goldman Sachs acting as joint book-running managers. 12 February 2024
Since the approval of the first CAR-T in 2017, T cell therapies have revolutionized the treatment of some blood cancers, and are one of the few cancer treatments to drive cures. 12 February 2024