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 National Institute for Health and Care Excellence (NICE) has opted against recommending Crysvita (burosumab) to treat adults in England and Wales who have a confirmed diagnosis of X-linked hypophosphataemia (XLH). 29 November 2023
UK biotech Arecor Therapeutics’ shares edged up more than 2% to 190.00 pence today, after it announced the signing of further collaboration agreement with US pharma major Eli Lilly. 29 November 2023
California, USA-based biotech firm BioMarin Pharmaceutical (Nasdaq: BMRN) has announced an agreement with the German National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement amount for Roctavian (valoctocogene roxaparvovec-rvox) for people with severe hemophilia A. 29 November 2023
Tokyo-based Daiichi Sankyo (TYO: 4568) has announced that its booster vaccine Daichirona for Intramuscular Injection (DS-5670) has been approved as an Omicron XBB.1.5-adapted monovalent mRNA vaccine against COVID-19. 29 November 2023
Belgian biotech Agomab Therapeutics today announced the appointment of Dr Angelika Jahreis as an independent non-executive director to its board of directors, while Andrea Sáez will join Agomab’s executive leadership team as chief development officer. 29 November 2023
The US Food and Drug Administration (FDA) yesterday said it has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous chimeric antigen receptor (CAR)-T cell immunotherapies. 29 November 2023
Shares of Dutch immunology specialist Argenx (Euronext: ARGX) have dropped around a tenth following negative results from the ADVANCE-SC study. 29 November 2023
US biopharma Novavax has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for its updated COVID-19 jab for active immunization to prevent COVID-19 in people aged 12 and older. 28 November 2023
Shares of US RNA-focussed biotech Avidity Biosciences leapt as much as 35% pre-market, after it announced a global licensing and research collaboration with pharma major Bristol Myers Squibb focused on the discovery, development and commercialization of multiple cardiovascular targets. 28 November 2023
Canada’s Xenon Pharmaceuticals has reported top-line results from the Phase II X-NOVA trial, showing the primary efficacy endpoint was not met. 28 November 2023
The US Food and Drug Administration (FDA) has accepted and granted priority review for the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), submitted by Abeona Therapeutics. 28 November 2023
USA-based venture capital and private equity company focused on life sciences, Flagship Pioneering, has marked the official opening of its UK hub. 28 November 2023
Roivant Sciences’ shares fell 4.7% to $8.70 in early morning trading yesterday, after it announced the Phase II study evaluating oral brepocitinib in adult patients with moderate to severe active lupus did not meet its primary endpoint. 28 November 2023
UK biotech start-up Myricx Bio has announced the publication today of ground-breaking research in Nature Cell Biology by its collaborators at the MRC-LMS (Laboratory of Medical Sciences) that has uncovered the central role of NMT as a druggable pathway in senescence. 28 November 2023
British pharma major AstraZeneca has established a new R&D center in Hong Kong, focused on research and development in areas including cell and gene therapies. 27 November 2023
Positive top-line data from the blinded extension phase of its Phase IIb ENLIVEN trial evaluating treatment with pegozafermin in patients with non-alcoholic steatohepatitis (NASH) were released today by 89bio. 27 November 2023
Following on from a deal announced last week, Swiss cancer company Oncoteq has unveiled an in-licensing agreement for an antibody-drug conjugate (ADC), codenamed TEQ102. 27 November 2023
Having pulled its multiple myeloma drug Blenrep (belantamab mafodotin) off the US market in 2022, and getting a negative recommendation from the European regulator in September this year, UK pharma major GSK has come back with promising new clinical data. 27 November 2023