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
A possible new indication for Sanofi’s IL-13 and IL-4 blocking antibody Dupixent (dupilumab) is on the cards, after a successful Phase III trial. 14 July 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended the use of Piqray (alpelisib) for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2), locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy. 14 July 2022
US biotech Gilead Sciences has announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of Trodelvy (sacituzumab govitecan) in England within its marketing authorization. 14 July 2022
Belgian biotech Agomab Therapeutics has extended its series B financing round with an additional close of $40.5 million, bringing the total to $114 million. 13 July 2022
An expert review of data from 79 real-world studies showed that AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [recombinant]) and the available mRNA COVID-19 vaccines provide equally effective protection against hospitalization and death from COVID-19 following two doses. 13 July 2022
US biopharma company Greenwich LifeSciences , which is focused on the development of GLSI-100, announced that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed. 13 July 2022
Positive results from the A-SURE study were presented at the 30th International Society on Thrombosis and Hemostasis (ISTH) Congress in London, demonstrating improved prophylactic effectiveness in Elocta (efmoroctocog alfa) treated patients compared to a matched treatment group on SHL FVIII treatments, according to Swedish Orphan Biovitrum, also known as Sobi. 13 July 2022
Agios Pharmaceuticals, a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today announced that effective August 8, 2022, Jackie Fouse will transition to the role of chairwomen of the board of directors and Brian Goff will assume the role of chief executive officer. 13 July 2022
A firm developing a novel vaccine technology, which could offer safer and more effective protection against infectious diseases, has appointed a new chief executive officer. 13 July 2022
The cell regeneration medicines market is currently valued at $30.3 billion and is anticipated to reach the valuation of $34.3 billion by the end of 2032 by growing at a CAGR of 14.4%, according to the latest report published by Future Market Insights. 13 July 2022
Centauri Therapeutics, a UK-based immunotherapy company focused on the treatment of infectious diseases, has announced three senior appointments at once. 12 July 2022
South Korean company LegoChem Biosciences and Germany’s Glycotope have signed a research collaboration and license agreement to develop an antibody drug conjugate (ADC). 12 July 2022
California, USA-based biotech Epic Bio, which is developing ultracompact therapies to modulate gene expression in vivo, today announced its launch and Series A financing of $55 million. 12 July 2022
Swiss clinical-stage biotech Vaccentis, which is developing patient-specific medicines, today announced the appointment of Martin Munte, a veteran leader in biotech and pharma. 12 July 2022
The US Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DoD), announced that it has secured 3.2 million doses of Novavax’ COVID-19 vaccine (NVX-CoV2373). 12 July 2022
Stockholm-based biotech Swedish Orphan Biovitrum and French drugmaker Sanofi have presented positive results from the XTEND-1 Phase III study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001). 11 July 2022
US mRNA specialist Moderna today announced new clinical data on its bivalent Omicron (BA.1) booster candidate, mRNA-1273.214, lifting the firm’s shares 1.5% to $179.07 by mid-morning. 11 July 2022
Swiss pharma giant Roche today announced results from the primary analysis of the Phase III HAVEN 6 study, which show that Hemlibra (emicizumab) continued to demonstrate a favorable safety profile and effective bleed control in people with moderate or mild hemophilia A, without factor VIII inhibitors. 11 July 2022
Research from industry analyst GlobalData suggests that India’s newly-approved COVID-19 vaccine, Gemcovac-19, could struggle to gain market share in the country. 11 July 2022