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
The Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of Madrigal Pharmaceuticals’ resmetirom and Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) for non-alcoholic steatohepatitis (NASH). 26 May 2023
Ultomiris (ravulizumab) has been approved in Japan as the first and only long-acting C5 complement inhibitor for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). 26 May 2023
US biopharma Apellis Pharmaceuticals and Swedish Orphan Biovitrum, also known as Sobi, have become the latest to discover the difficulty of drug development in amyotrophic lateral sclerosis (ALS). 26 May 2023
Anglo-Swedish drugmaker AstraZeneca is lining up the big-hitters from its cancer drug portfolio for next week’s American Society of Clinical Oncology (ASCO) Annual Meeting. 25 May 2023
USA-based ClearPoint Neuro a global therapy-enabling platform company providing navigation and delivery to the brain, saw its shares rise 3% to $8.15 pre-market today, on news of a multi-year license agreement with Belgium’s largest pharma company, UCB, to partner on drug delivery platforms for UCB’s gene therapy portfolio. 25 May 2023
Shares of US oncology drugmaker Mirati Therapeutics closed down 4% on Wednesday and were a further 8.7% lower at $40.01 in pre-market activity today, after it revealed that the SAPPHIRE study did not meet its primary endpoint of overall survival (OS) at the final analysis. 25 May 2023
Boston, USA-based cell and gene therapy incubator ElevateBio has raised $401 million in a series D financing round led by AyurMaya Capital Management Fund. 24 May 2023
UK headquartered Biodexa Pharmaceuticals, a company developing treatments for metastatic brain cancers, has signed non-binding letter of intent to potentially acquire Varian Biopharmaceuticals, a private US precision oncology company developing novel therapeutics for the treatment of cancer. 24 May 2023
Shares of Belgian biotech BioSenic were up more than 11% at 0.13 euros today, after it announced the signing of a term sheet with Pluristyx, a leading provider of gene-edited iPSC and cell therapy solutions, with a view to further negotiate the terms and conditions of a potential license and collaboration agreement. 24 May 2023
US RNA medicines company Wave Life Sciences saw its shares close up 2.7% at $3.81 yesterday, despite announcing that it is discontinuing an important program. 24 May 2023
While financial experts may debate the merits and demerits of the initial public offering (IPO), it’s not the only way to take a company public. 24 May 2023
Ichthyosis is a heterogenous group of disorders characterized by dry, itchy skin that appears scaly and rough like fish scales.1,2 The first case of ichthyosis was described 24 May 2023
US gene therapy company Avrobio saw its shares close up a massive 69% at $1.31 yesterday, after it said it is selling its investigational hematopoietic stem cell (HSC) gene therapy program for the treatment of cystinosis to Swiss pharma giant Novartis. 23 May 2023
The US Food and Drug Administration (FDA) yesterday approved Ayvakit (avapritinib) for the treatment of adults with indolent systemic mastocytosis (ISM), said Blueprint Medicines. 23 May 2023