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
Massachusetts, USA-based biotech incubator Flagship Pioneering and US pharma giant Pfizer have announced a novel agreement to create a new pipeline of innovative medicines. 19 July 2023
UK biotech start-up Bloomsbury Genetic Therapies says that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation (RPDD) for BGT-OTCD, the company’s investigational liver-targeted gene therapy for the treatment of Ornithine transcarbamylase deficiency (OTCD). 19 July 2023
Boston, USA-based clinical-stage biotech Pieris Pharmaceuticals saw its shares surge as much as 70%, and still up 27% at $0.24 mid-morning, after it provided a strategic update following recent events that have impacted its inhaled respiratory franchise. 18 July 2023
Privately held, venture-funded biotech Revolo Biotherapeutics today announced additional data from its proof of concept, two-week, three-dose, Phase IIa clinical trial evaluating the efficacy, safety, and tolerability of the company’s immune-resetting drug, ‘1104, in adults with active eosinophilic esophagitis (EoE). 18 July 2023
The US Food and Drug Administration (FDA) has approved Beyfortus (nirsevimab-alip) for the prevention of RSV lower respiratory tract disease in neonates and infants. 18 July 2023
Shares of Swedish Orphan Biovitrum, also known as Sobi, edged up 3% to 212.00 kronor today, after it posted financial results for the second quarter of 2023. 18 July 2023
The European Medicines Agency (EMA) has accepted for review the marketing authorization application for bimekizumab, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), submitted by Belgium’s largest pharma company UCB. 18 July 2023
Over the last few days, attendees of the ongoing annual meeting of the Alzheimer’s Association have been arriving in Amsterdam for what has turned out to be a particularly exciting congress. 18 July 2023
UK-based CAR-T therapies specialist Leucid Bio today announced the appointment of Filippo Petti as its chief executive (CEO), with immediate effect. 18 July 2023
While targeted protein-busting antibodies are revolutionizing the treatment of Alzheimer’s disease, a damaging side effect - amyloid-related imaging abnormalities (ARIA) - has emerged as a differentiator among the growing number of options. 17 July 2023
Belgo-Dutch autoimmune diseases specialist argenx has announced positive top-line results from the ADHERE study evaluating Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy (CIDP). 17 July 2023
DTx Pharma, a San Diego, USA-based pre-clinical stage biotechnology company, today announced that it has been acquired by Swiss pharm giant Novartis. 17 July 2023
Venture capital firm Westlake Village BioPartners has announced the launch of its third fund of $450 million to incubate and grow early-stage biotech companies in the Los Angeles area and further afield. 17 July 2023
Market reaction to genetic medicines developer Sangamo Therapeutics announcement of an evaluation and option agreement with Prevail Therapeutics, a wholly-owned subsidiary of Eli Lilly, was positive pre-market, with its shares rising 9.2% to $1.41. 17 July 2023
At the AAIC in Amsterdam, we’re speaking with two key figures from Lilly's development program for donanemab, as the company presents new data that could help it to push ahead in the treatment of early Alzheimer's. 17 July 2023
Fragile X syndrome (FXS) is an X-linked dominant disorder characterized by a broad range of clinical manifestations, including intellectual disability, autism spectrum disorder, language deficits, macroorchidism, seizures, and anxiety. 17 July 2023