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
Adding to its US regulatory clearance in August, the European Commission (EC) has now also granted conditional marketing authorization for Elrexfio (elranatamab), from US pharma giant Pfizer. 8 December 2023
British drugmaker AstraZeneca has published research in The Lancet outlining the impact of Fasenra (benralizumab) in severe eosinophilic asthma. 8 December 2023
China’s National Medical Products Administration (NMPA) has approved the supplemental biologics license application (sBLA) for Cejemly (sugemalimab) alongside fluorouracil and platinum-based chemotherapy as a first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). 8 December 2023
US biotech Novavax has an advanced purchase agreement (APA) with the European Commission and an arrangement with the UK for the supply of the firm’s COVID-19 vaccine, developed with its Matrix-M adjuvant. 8 December 2023
Australian regulator the Therapeutic Goods Administration (TGA) says that its investigation into the risk of myocardial infarction and stroke in patients taking romosozumab (Evenity) found that stronger warnings regarding these risks were needed in the Product Information (PI) and Consumer Medicine (CMI) Information external sites. 8 December 2023
German biotech BioNTech revealed that it has signed a multi-year strategic partnership with the State of Victoria in Australia to strengthen the local mRNA ecosystem and facilitate innovations deriving from it. 8 December 2023
Netherlands-based Synaffix, which was recently acquired by Swiss contract development and manufacturing organization (CDMO Lonza, said today it has expanded its licensing agreement with China’s Innovent Biologics. 7 December 2023
Shares of Switzerland-based clinical-stage drug developer Pharvaris rose by as much as 42% Wednesday morning, as it announced positive top-line data from the CHAPTER-1 Phase II clinical study meeting its primary endpoint, with deucrictibant. 7 December 2023
At an investor R&D day in New York, French drugmaker Sanofi provided an update on developments regarding its pipeline and what it expects to be key growth drivers in the future. 7 December 2023
Ireland and USA-based natural killer (NK) cell therapy biotech ONK Therapeutics and US firm NAYA Biosciences have entered into a research partnership to evaluate combination therapy consisting of ONK’s optimally-engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK bispecific antibodies. 6 December 2023
Massachusetts, USA-based cell therapy specialist Abcuro today announced the appointment of Mark Pruzanski as chairman of its board of directors. 6 December 2023
Israel-based Teva Pharmaceutical Industries presented post hoc analysis of two Phase III studies at the European Headache Congress, showing the effectiveness of its already marketed migraine prevention treatment Ajovy (fremanezumab) in reducing migraine attacks in patients with migraine and co-morbid obesity. 6 December 2023
Germany-based Thermosome, a drug development company specializing in targeted tumor therapies, has named Frank Hermann as chief medical officer (CMO). 5 December 2023
Specialty biopharma firm Emergent BioSolutions has been awarded a $75 million option under an existing agreement with the Biomedical Advanced Research and Development Authority (BARDA). 5 December 2023
Shares of UK-based cancer and women’s health drug developer ValiRx were up 16.6% at 11.51 pence mid-afternoon, following the announcement that its joint venture company ValiSeek has entered a deal to license VAL401 to Ambrose Healthcare 5 December 2023
Japan’s largest drugmaker Takeda has announced the signing of a three-year memorandum of understanding (MoU) with the Biotechnology Industry Research Assistance Council (BIRAC). 5 December 2023