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
Switzerland-based Myovant Sciences and Pfizer have announced positive one-year data from the Phase III SPIRIT extension study of once-daily relugolix combination therapy in women with endometriosis. 28 January 2021
French specialty vaccine company Valneva saw its shares gain almost 5% to 9.58 euros by midday, after the company announced it has started commercial production of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, at its manufacturing plant in Livingstone, West Lothian, Scotland. 28 January 2021
While UK-based drugmaker AstraZeneca has not yet received European approval for its coronavirus vaccine, the trading bloc is already up in arms about the amount it can get its hands on. 28 January 2021
AstraZeneca has selected a novel chronic kidney disease (CKD) target to advance to its drug development portfolio, under its collaboration with fellow UK-based artificial intelligence (AI) company BenevolentAI. 28 January 2021
In what is seen as a unique collaboration, Eli Lilly, Vir Biotechnology and GlaxoSmithKline yesterday announced they were joining forces to evaluate a combination of two COVID-19 therapies in low-risk patients with mild-to-moderate COVID-19. 28 January 2021
A post-marketing safety study of Pfizer’s Xeljanz (tofacitinib) has missed both primary endpoints, threatening to undermine the drug’s competitiveness among rival options. 28 January 2021
The National Institute for Health and Care Excellence (NICE) has recommended the use of Revlimid (lenalidomide) as maintenance treatment after an autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma in adults. 27 January 2021
Whether politicians choose to accept it or not, the countries of the world are engaged in a race to vaccinate their populations against the novel coronavirus - and winners are already beginning to emerge. 27 January 2021
French pharma major Sanofi today revealed it has entered into an agreement with Germany’s BioNTech under which Sanofi will support manufacturing and supply of BioNTech’s COVID-19 vaccine. 27 January 2021
US President Joe Biden has announced plans to boost vaccine supplies to US states by around 1.4 million doses per week, as the country scrambles to protect itself from the novel coronavirus. 27 January 2021
The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) today issued interim recommendations for the use of the mRNA-1237 vaccine against COVID-19 developed by US biotech Moderna. 26 January 2021
Regeneron Pharmaceuticals today announced positive initial results from an ongoing Phase III clinical trial evaluating REGEN-COV (casirivimab and imdevimab antibody cocktail) used as a passive vaccine for the prevention of COVID-19 in people at high risk of infection (due to household exposure to a COVID-19 patient). 26 January 2021
An inhaled interferon beta-1a treatment from Southampton, UK-based respiratory specialist Synairgen is to be included in a large trial testing agents against the novel coronavirus. 26 January 2021
Pharma Foods International (PFI) has entered into exclusive licensing agreement with fellow Japan-based Mitsubishi Tanabe Pharma (MTPC) for a new therapeutic antibody to treat autoimmune diseases. 26 January 2021
A subsidiary of French nanotechnology expert Nanobiotix, Curadigm, has been selected for the Sanofi iTech awards program, as a “highly promising option” to improve gene therapies. 26 January 2021
US biotech Moderna saw its shares gain 7.5% to $140.84 by late-morning trading today, as it announced encouraging results from in vitro neutralization studies of sera from individuals vaccinated with its Moderna COVID-19 Vaccine showing activity against emerging strains of SARS-CoV-2. 25 January 2021
Roche today announced positive top-line results from two identically designed global Phase III studies, TENAYA and LUCERNE, evaluating the Swiss pharma giant’s investigational bispecific antibody, faricimab, in people living with neovascular or “wet” age-related macular degeneration (nAMD). 25 January 2021