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 Cell and Gene Therapy Catapult (CGT Catapult), a government-funded body encouraging the development of the advanced therapy sector, has published a report into trial activity in the UK. 18 January 2024
US clinical stage developer Immunitas Therapeutics today announced the appointment of Annalisa D’Andrea as its chief scientific officer (CSO). 18 January 2024
California, USA-based biotech BridgeBio Pharma (Nasdaq: BBIO) today announced strategic financing from Blue Owl Capital and Canada Pension Plan Investment Board (CPP Investments), bringing in capital of up to $1.25 billion. 18 January 2024
While 2023 saw the approval of many notable new drugs by the US Food and Drug Administration (FDA), the past year also featured many holds being imposed on clinical trials. 18 January 2024
Dutch immunology specialist argenx has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Vyvdura (efgartigimod alfa and hyaluronidase-qvfc; also marketed under the Vyvgart brand name) injection subcutaneous (SC). 18 January 2024
Japanese drugmaker Daiichi Sankyo yesterday announced that the US Patent and Trademark Office (US PTO) rendered a Final Written Decision invalidating all claims of Seagen’s US patent 10,808,039 (the ’039 patent) that were challenged by Daiichi Sankyo in a post-grant review proceeding (PGR). 18 January 2024
Two new initial public offerings (IPO) are set to go ahead in the USA, raising hopes of a thaw in what has been a long winter for biotech companies going public. 17 January 2024
Belgian clinical-stage biotech PDC*line Pharma today announced the selection of the PDC*neo+ project for funding by the Walloon region and BioWin, the health cluster for Wallonia. 17 January 2024
With the aim of boosting is leadership team, clinical-stage biotech Zura Bio today announced the appointments of Robert Lisicki as president and chief operating officer, and Kiran Nistala as executive vice president development and chief medical officer, to the executive leadership team. 17 January 2024
Just a month after winning its first US approval for sickle cell disease (SCD), Casgevy (exagamglogene autotemcel [exa-cel]) has won a second Food and Drug Administration (FDA) approval. 17 January 2024
California, USA-based biotech Allakos yesterday announced disappointing top-line data from its Phase II clinical trial in patients with atopic dermatitis (ATLAS) and from its Phase IIb clinical trial in patients with chronic spontaneous urticaria (MAVERICK). 17 January 2024
Canada-headquartered Genevant Sciences, a privately-held company of the Roivant family, has announced a collaboration and non-exclusive license agreement with Massachusetts, USA-based Tome Biosciences. 17 January 2024
Shares of US clinical-stage biotech Aclaris Therapeutics shot up as much as 40% to $1.21 in early trading today, after it announced leadership changes and that it is undertaking a strategic review of its business. 16 January 2024
New York, USA-based rare neurological disease drug developer Neurogene has announced the appointment of Julie Jordan as its chief medical officer (CMO). 16 January 2024
The European Commission has granted marketing authorization for yet another indication for Swiss pharma giant Roche’s cancer drug Tecentriq SC (atezolizumab; subcutaneous). 16 January 2024
In potentially the biggest pharma licensing deal ever, Japanese pharma major Daiichi Sankyo and US drug giant Merck & Co announced a collaboration in October. 16 January 2024
Food and healthcare company Orion Group has made a bold step to expand its biotech interests, buying around a quarter of LegoChem Biosciences (Kosdaq: 141080) for $420 million. 16 January 2024
DISCO Pharmaceuticals, a specialist biotech unlocking the surfaceome of cancer cells at scale to identify new targets and develop first in class drugs, today emerges from stealth. 16 January 2024
Arena BioWorks has announced its launch as a biomedical research institute with a mission to uncover mechanisms of disease by engaging in basic biological research that will be translated into lifesaving biotech therapeutics. 15 January 2024