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
UK pharma major GlaxoSmithKline and US partner Vir Biotechnology announced US government contracts totaling around $1 billion to purchase sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19. 18 November 2021
Biotech start-up Ribonexus (previously called Aglaia Therapeutics) and fellow France-based drugmaker Pierre Fabre today announced an exclusive license agreement on a series of Pierre Fabre patented small molecules targeting the Eukaryotic translation initiation factor 4A (eIF4A). 18 November 2021
Ever since June’s landmark nod for Alzheimer’s medicine Aduhelm (aducanumab), the industry has been stirred by heated debate around the context of the potential super-blockbuster’s approval. 18 November 2021
New data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination. 18 November 2021
French pharma major Sanofi today announced an equity investment of $180 million and a new strategic collaboration with Owkin comprised of discovery and development programs in four exclusive types of cancer, with a total payment of $90 million for three years plus additional research milestone-based payments. 18 November 2021
Medical technology company Terumo Blood and Cell Technologies and Immunicom, a biotech pioneering subtractive immunotherapies, have signed a co-commercialization agreement. 17 November 2021
Bristol Myers Squibb has welcomed the positive recommendations of the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, relating to two of its cancer drugs. 17 November 2021
The Institute for Clinical and Economic Review (ICER) has published a Final Evidence Report assessing the comparative clinical effectiveness and value of mavacamten, a drug being developed for hypertrophic cardiomyopathy (HCM). 17 November 2021
Cytokine immunotherapy company Bright Peak Therapeutics has in-licensed a checkpoint blocker from Guangdong, China-based biotech Livzon Mabpharm. 17 November 2021
The European Commission has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use in three additional eosinophil-driven diseases. 17 November 2021
China’s biotech industry enjoyed significant growth in the past several years, but major bottlenecks are looming as Chinese biotechs aims for a global expansion, said speakers at the two-day event Chinatrials on November 11 in Shanghai. 17 November 2021
US biotech Biogen surprised industry watchers, with the announcement that Alfred (Al) Sandrock Jr, head of research and development, will retire from the company effective December 31, 2021. 17 November 2021
Czech immuno-oncology company SOTIO Biotech, which is owned by PPF Group, today announced an exclusive, target-specific license and option agreement with South Korean biotech LegoChem Biosciences, a company focused on developing its clinical-stage platform technology enabling antibody-drug conjugates (ADCs). 16 November 2021
While injectable PCSK9 inhibitors have long promised an effective way to lower LDL cholesterol levels, relatively low uptake has been blamed on high prices and a burdensome mode of administration. 16 November 2021
The neuromyelitis optica spectrum disorder (NMOSD) therapeutics market is highly genericized, with corticosteroids and immunosuppressants currently accounting for the highest portion of prescribed drugs in China. 16 November 2021
US DNA synthesis firm Twist Bioscience has launched Revelar Biotherapeutics, an independently operated, new biotechnology company to develop and commercialize an antibody, discovered and optimized by its Twist Biopharma division, that neutralizes all known variants of concern of the SARS-CoV-2 virus in pre-clinical studies. 16 November 2021
A set of guidelines that will provide a well-defined framework and guiding principle to facilitate sharing of biological information and data generated by research groups in India has been released by the government. 16 November 2021
Australian off-the-shelf cell therapy specialist Mesoblast saw its shares gain nearly 12% to A$1.90 today, as it released positive new results from the landmark Phase III study of rexlemestrocel-L in 565 patients with chronic heart failure (CHF) with reduced ejection fraction (HFrEF). 15 November 2021