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
US neurology specialist Neurocrine Biosciences saw its shares fall 4.4% to $107.17 after it announced negative Phase II study results from two signal-seeking pipeline programs in focal onset seizures and anhedonia. 13 November 2023
Cambridge, UK-based drug discovery and development company Mission Therapeutics today announced the publication of a peer-reviewed article titled ‘Knockout or inhibition of USP30 protects dopaminergic neurons in a Parkinson’s disease (PD)’ in the journal Nature Communications. 13 November 2023
UK-based Barinthus Biotherapeutics today presented data from two hepatitis B virus (HBV) clinical trials at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2023. 10 November 2023
The US Food and Drug Administration yesterday approved Japanese pharma major Takeda’s Adzynma (ADAMTS13, recombinant-krhn; TAK-755), adding to the approval a day earlier of the firm’s bowel cancer drug Fruzaqla (fruquintinib). 10 November 2023
Belgium’s largest pharma company, UCB, has announced new long-term data from the Bimzelx (bimekizumab) Phase IIb study BE AGILE and its open label extension (OLE). 10 November 2023
The US Food and Drug Administration (FDA) has approved Ixchiq, French specialty vaccines developer Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus. 10 November 2023
UK oncology-focussed biotech ValiRx edged up 2.5% to 12.30 pence this morning, after it announced it has entered into an agreement with StingRay Bio to investigate a lead series of drug candidates for use in oncology. 10 November 2023
A Phase II failure for Californian cell therapy company Atara Biotherapeutics has prompted a share sell-off, with the company’s stock falling 80% in value on Thursday. 10 November 2023
Cells are the basic unit of life and are themselves living. They coordinate, construct, kill, and multiply. Using human cells as medicines is as intuitively thrilling as it is technically difficult. 9 November 2023
WuXi XDC has published a prospectus for its upcoming initial public offering (IPO), detailing plans to raise $470 million with a listing on the Hong Kong Stock Exchange. 9 November 2023
The UK's National Institute for Health and Care Excellence (NICE) has recommended Lamzede (velmanase alfa) in its final evaluation document as an option for treating the non-neurological signs and symptoms of mild to moderate alpha-mannosidosis in England and Wales. 9 November 2023
The market for myasthenia gravis (MG), an autoimmune and neuromuscular disease characterized by muscle weakness and fatigue, is set to experience a compound annual growth rate (CAGR) of 8.3% across the seven major markets. 9 November 2023
Britain’s biggest drugmaker AstraZeneca has exceeded revenues expectations handily in the third quarter 2023, with robust demand in oncology leading the way. 9 November 2023
US biotech major Biogen today reported third quarter 2023 results and updated full year 2023 guidance that failed to impress investors, with its shares falling 4.7% to $235.34 in early trading’ 8 November 2023
Californian drugmaker Gilead Sciences has exceeded estimates in the third quarter, with revenues of around $7.1 billion and earnings per share (EPS) of $1.73. 8 November 2023
Danish drugmaker Genmab has reported third quarter 2023 revenues of 4.7 billion Danish kroner ($420 million), better than the 4.5 billion kroner expected according to the FT consensus forecast. 8 November 2023
South Korea’s Chong Kun Dang Pharmaceutical's stock soared 26.1% to end at 128,000 won on Monday, on news of a deal with Swiss pharma giant Novartis. 7 November 2023