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
Two new approvals for Opdivo (nivolumab)-based regimens in esophageal squamous cell carcinoma (ESCC) will bring meaningful competition for the leading checkpoint blocker, Keytruda (pembrolizumab). 31 May 2022
The UK Medical Research Council (MRC) and its Laboratory of Molecular Biology (LMB) have agreed to an additional $4millon (~£3.2million) funding to extend the Blue Sky collaboration with UK pharma major AstraZeneca beyond 2022. 31 May 2022
New pivotal data is to be presented on Roche’s CD20xCD3 T-cell engaging bispecific antibody, glofitamab at this week’s 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2022 Congress. 30 May 2022
NRG Therapeutics, a privately-held UK-based neuroscience company targeting mitochondrial dysfunction, has received a Biomedical Catalyst (BMC) award from the UK government. 30 May 2022
Taiwanese biotech firm AcadeMab has broken new ground in the development of immunotherapies through the development of a potentially life-saving monoclonal antibodies (MAbs) for COVID-19 patients using single B cell technology, shows the best neutralization ability (IC50 = 11.4 and 4.3 ng/ml) in both Omicron variants BA.1 and BA.2 respectively. 30 May 2022
At the 2022 annual meeting of the American Society of Clinical Oncology (ASCO 22), Shanghai-based cancer company I-Mab is presenting new Phase I data for uliledlimab. 30 May 2022
German biotech Evotec today announced the signing of a definitive agreement to acquire 100% of the capital of Rigenerand Srl, an Italian cell technology company. 30 May 2022
The US Food and Drug Administration has granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy, said Swiss pharma giant Novartis. 28 May 2022
US late-stage biotech Iovance Biotherapeutics has reported results from its C-144-01 clinical study in patients with advanced (unresectable or metastatic) melanoma who progressed on prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also on prior BRAF or BRAF/MEK inhibitor therapy. 28 May 2022
A new kind of therapy which raises the prospect of an off-the-shelf approach to CAR T-cell treatment has scored an early-stage win, lifting shares in developer Adicet Bio. 27 May 2022
Budget medicine specialist EQRx, a company focused on delivering innovative medicines at significantly lower prices, will present new data for its two lead programs at the annual meeting of the American Society of Clinical Oncology (ASCO 22). 27 May 2022
US biotech major Amgen has promised new data from across its oncology innovative medicines and biosimilars portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting next week. 27 May 2022
Switzerland-headquartered biotech Addex Therapeutics shares were down 4.7% at 0.59 francs after it announced that the outcome of a small Phase IIa feasibility study of dipraglurant in patients with blepharospasm was inconclusive and did not meet all of its objectives. 27 May 2022
The race to meet sudden, stratospheric demand for new anti-obesity meds is hotting up, but Novo Nordisk CEO Lars Fruergaard Jørgensen takes a collegiate approach. 26 May 2022
Japanese drugmaker Chugai Pharmaceutical announced that it launched anti VEGF/anti Ang-2 bispecific antibody Vabysmo Intravitreal Injection 120 g/mL (faricimab [genetical recombination]) for the treatment of age-related macular degeneration associated with subfoveal choroidal neovascularization and diabetic macular edema (DME). 26 May 2022
Roche has won approval from the European Commission (EC) for the use of Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adults with untreated diffuse large B-cell lymphoma (DLBCL). 26 May 2022
Following a European Medicines Agency recommendation in March, the European Commission has now granted formal approval for Carvykti (ciltacabtagene autoleucel, or cilta-cel), from Johnson & Johnson’s subsidiary Janssen. 26 May 2022
Antios Therapeutics has been given the cold shoulder by erstwhile development partner Assembly Biosciences, after a clinical hold was placed on its hepatitis B program. 26 May 2022
Belgium-based biotech Galapagos has exercised its option to in-license novel drug targets for inflammatory bowel disease (IBD) discovered by Scipher Medicine’s Spectra platform. 26 May 2022