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
Incyte Corporation has announced that the Phase III trial of Jakafi (ruxolitinib) in steroid-refractory or steroid dependent chronic graft-versus-host disease (GVHD) met its primary endpoint of superior overall response rate (ORR) at week 24, compared to best available therapy (BAT). 23 July 2020
The transthyretin amyloidosis (ATTR) market is expected to grow from $585 million in 2019 to $14.1 billion in 2029 across the seven major markets, according to GlobalData. 23 July 2020
Dutch biotech firm Synaffix today announced that Swiss oncology-focused drug discovery firm ADC Therapeutics has expanded its existing collaboration to explore additional applications, including DAR1, of Synaffix’ site-specific conjugation technologies. 23 July 2020
The UK’s capability to manufacture vaccines has received a substantial boost today, as the government announces an additional £100 million ($127 million) to ensure that any successful COVID-19 vaccine can be produced at scale in the UK. 23 July 2020
Swiss pharma giant Roche has presented detailed results from the Phase III Archway study of its investigational Port Delivery System (PDS). 23 July 2020
Putting the final nail in the coffin for its non-alcoholic steatohepatitis (NASH) drug candidate, French metabolic specialist Genfit today announced the discontinuation of the RESOLVE-IT Phase III clinical trial of elafibranor in adults with NASH and fibrosis. 23 July 2020
Shares of Swiss pharma giant Roche were down more than 2% in early trading today, after it revealed that second-quarter 2020 sales fell 9.6% to 14.1 billion Swiss francs ($15.20 billion). Factoring out the strength of the franc, revenue dropped 4%. 23 July 2020
Adding to a major supply deal with the UK earlier this week, today Pfizer and German partner BioNTech announced an agreement with the US Department of Health and Human Services and the Department of Defense to meet the government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. 22 July 2020
Shares in US biotech Biogen were up by 1.5% following 90 minutes of trading on Wednesday after the company presented its second quarter financial results. 22 July 2020
Japanese drugmaker Daiichi Sankyo has teamed up with Paris-based cancer research institute Gustave Roussy in a multi-year, multi-study research collaboration. 22 July 2020
The USA’s Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of obeticholic acid (OCA), from Intercept Pharmaceuticals (Nasdaq: ICPT), for the treatment of non-alcoholic steatohepatitis (NASH) with fibrosis. 22 July 2020
Oral Janus kinase (JAK) inhibitor Rinvoq (upadacitinib) 15mg and 30mg, once daily monotherapy met both primary and all secondary endpoints in Measure Up 2, the second Phase III study in individuals with moderate to severe atopic dermatitis. 22 July 2020
The Seattle-based subsidiary of Hamburg’s Evotec will develop COVID-19 antibodies for the US Department of Defense (DoD), under an $18.2 million contract. 22 July 2020
Gilead Sciences’ shares dipped 1.7% to $76.76 on Tuesday, after it announced that it will invest $300 million to acquire a 49.9% equity interest in Tizona Therapeutics, a privately held company developing first-in-class cancer immunotherapies, with the intention of buying the whole company later. 22 July 2020
A new project from the European Medicines Agency (EMA) has been established to monitor the efficacy and safety of COVID-19 treatments and vaccines in everyday clinical practice. 21 July 2020
Houston, USA-based CNS Pharmaceuticals has lined up both American and European manufacturers for berubicin, its lead drug candidate for the treatment of glioma brain tumors. 21 July 2020
Privately-held US start-up Jnana Therapeutics has entered a strategic, multi-target collaboration and license agreement with Roche (ROG: SIX) for the discovery of small molecule drugs directed at the solute carrier (SLC) family of metabolite transporters. 21 July 2020
Privately held Danish drugmakers Union Therapeutics and LEO Pharma have completed a transaction for the former to acquire the global rights to the LEO PDE4 inhibitor compound series to be re-named UNI500. 21 July 2020