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
US precision medicines company IDEAYA Biosciences saw its shares leap 15.5% to $3.50 by mid-day, after it revealed a clinical trial collaboration with pharma giant Pfizer. 18 March 2020
Danish diabetes care giant Novo Nordisk has announced that two Phase III clinical trials and one Phase II trial for concizumab have been paused, due to: “non-fatal thrombotic events” in three patients. 18 March 2020
UK gene and cell therapy company Oxford Biomedica has signed a new licence and clinical supply agreement (LSA) with Juno Therapeutics, a part of Bristol-Myers Squibb. 18 March 2020
Ophthalmic gene therapy company Horama has announced an exclusive licensing agreement for global rights to a program targeting retinal dystrophy associated with pathogenic CRB1 gene mutations. 18 March 2020
US biotech Moderna on Monday announced that the first participant has been dosed in the Phase I study of its mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). 17 March 2020
Privately-held Singapore-based company Tessa Therapeutics’ CD30-directed autologous CAR-T therapy has received US Food and Drug Administration (FDA) regenerative medicine advanced therapy (RMAT) designation. 17 March 2020
US biotech Microbiotix has been awarded up to $2.86 million in non-dilutive funding by CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) to develop a new oral antibiotic to treat multidrug-resistant gonorrhea. 17 March 2020
US clinical-stage biotech Provention Bio yesterday announced a temporary pause in the randomization of patients with newly diagnosed type 1 diabetes (T1D) into its global Phase III PROTECT study of PRV-031 (teplizumab. 17 March 2020
Nucala (mepolizumab) has now been approved in Canada as an add-on maintenance treatment for use in adults, adolescents and children (aged six years and older) with severe eosinophilic asthma. 17 March 2020
The Franco-American pairing of Sanofi and Regeneron have rapidly ramped up a coronavirus (COVID-19) trial of Kevzara (sarilumab), a drug that is currently approved for rheumatoid arthritis (RA). 16 March 2020
US drugmakers Eli Lilly and Incyte Corp have announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to baricitinib for the treatment of alopecia areata (AA). 16 March 2020
A new partnership between Vancouver-based AbCellera and Eli Lilly will use antibodies from former COVID-19 patients as the basis for an antibody therapy for the disease. 16 March 2020
Germany’s Merck and Pfizer today announced a disappointing update from the Phase III JAVELIN head and neck 100 study evaluating avelumab in addition to chemoradiotherapy (CRT) versus standard-of-care CRT in patients with untreated locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). 16 March 2020
Oxford BioDynamics, a UK biotech focused on the discovery and development of biomarkers, based on regulatory 3D genome architecture, using its liquid biopsy platform EpiSwitch, announces that Dr Jon Burrows has been appointed as group chief executive, effective 23 March 2020. 16 March 2020
German newspaper Welt am Sonntag over the weekend said that US President Donald Trump “had offered funds” to entice German mRNA-based drug specialist CureVac to move its recently started COVID-19 R&D work to the USA, and the German government was now “making counter-offers to tempt it to stay.” 16 March 2020
Germany immunotherapeutics firm BioNTech today provided further details on its R&D effort, “Project Lightspeed,” to develop a potential vaccine to induce immunity and prevent COVID-19 infection in response to the growing global health threat posed by the disease. 16 March 2020