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
India-based Biocon Biologics (BBL), a subsidiary of India’s Biocon, and Serum Institute Life Sciences (SILS) ), a subsidiary of Serum Institute of India, have announced an important strategic alliance that will enable them to make a stronger global impact. 17 September 2021
US biotech Moderna has highlighted new findings suggesting that the company’s Spikevax COVID-19 vaccine is highly effective against circulating ‘variants of concern’. 16 September 2021
UK-based biotech Touchlight has announced an extension of its fundraising round to a current aggregate total of $125 million (£92 million GBP). The round was led by Bridford Investments Limited and Novator Partners. 16 September 2021
Orladeyo (berotralstat) is to be made available on the National Health Service (NHS) for hereditary angioedema (HAE) patients in England, Wales and Northern Ireland, the UK’s National Institute for Health and Care Excellence (NICE) has recommended. 16 September 2021
US drug developer Theravance Biopharma’s shares fell as much as 39% and closed yesterday down 15.8% at $6.77, after the company released disappointing trial results for its ampreloxetine and followed this with an announcement on refocussing its portfolio and reducing staff numbers. 16 September 2021
Swiss drugmaker Vifor Pharma and USA-based Travere Therapeutics have entered into a joint collaboration and licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand. 16 September 2021
The US Food and Drug Administration has granted accelerated approval for Brukinsa (zanubrutinib) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. 16 September 2021
The US Department of Health and Human Services (HHS) and the Department of Defense (DOD) have agreed to buy1.4 million additional doses of REGEN-COV (casirivimab and imdevimab) from US biotech Regeneron Pharmaceuticals. 15 September 2021
German mRNA specialist CureVac, once seen as a leader in the race to develop a coronavirus vaccine, has scaled back its ambitions after disappointing trial results. 15 September 2021
Arenaviral immunotherapies company Hookipa Pharma has entered into a clinical collaboration and supply agreement with US pharma giant Merck & Co. 15 September 2021
The market value of Swedish biopharma Calliditas Therapeutics dropped by 24% during Wednesday’s trading after a blow to its hopes for Nefecon. 15 September 2021
Austrian precision cancer medicines focused biotech OncoOne has appointed Brent Meadows to its executive management team as chief business officer (CBO). 15 September 2021
German pharma major Bayer has added to the case for using Nubeqa (darolutamide) to treat non-metastatic castration-resistant prostate cancer (nmCRPC), for which the androgen receptor inhibitor was approved in the USA in 2019. 15 September 2021
Bristol Myers Squibb is to present new three-year data from the CheckMate-743 trial of Opdivo (nivolumab) plus Yervoy (ipilimumab) at the European Society of Medical Oncology’s (ESMO) annual congress. 15 September 2021
Cambridge, USA-based EQRx, a biotech firm focused on developing lower-cost innovative medicines, has announced new data from a trial of its lung cancer candidate, sugemalimab. 15 September 2021
Following the transformational merger with DCprime in December 2020, Swedish biotech Immunicum now aims to become a global leader in off-the-shelf, allogeneic cell therapies, using its expertise in dendritic cell (DC) biology, comment analysts at Edison Investment Research. 15 September 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in Great Britain for Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor. 14 September 2021
Dutch biotech Pharming Group has announced top-line results from two pilot clinical trials of Ruconest (recombinant human C1 inhibitor) for the prevention of severe SARS-CoV-2 infection. 14 September 2021
Canadian biotech AbCellera yesterday announced it has acquired TetraGenetics, a USA-based company with a proprietary platform for generating recombinant human ion channels and other transmembrane proteins. 14 September 2021