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
Geneva-based cell-line company Selexis and NexImmune, a T cell specialist, has signed a service agreement to develop cell lines targeting rare cancers and autoimmune diseases. 9 September 2022
SpringWorks Therapeutics shares were up 8% to $27.97 after the US biotech announced that it has entered into an expanded global, non-exclusive license and collaboration agreement with UK pharma major GSK. 9 September 2022
A less cumbersome dosing schedule for Eylea (aflibercept) has been shown safe and effective in late-stage trials, boosting its developers' chances of defending market share. 9 September 2022
Spanish dermatology company Almirall has provided some detail on the results from a Phase III atopic dermatitis (AD) trial of lebrikizumab. 8 September 2022
Privately-held Danish dermatology specialist LEO Pharma has presented new safety data on Adtralza (tralokinumab) at the European Academy of Dermatology and Venereology (EADV) Congress. 8 September 2022
US biotech Vertex Pharmaceuticals today announced that Jonathan Biller has been appointed chief legal officer, effective September 19, 2022. 8 September 2022
Positive Phase III results have been presented on eplontersen, a ligand-conjugated antisense therapy from US RNA-targeted drug developer Ionis Pharmaceuticals and Anglo-Swedish pharma major AstraZeneca. 8 September 2022
LifeArc revealed that its portfolio company Ducentis BioTherapeutics, a pre-clinical-stage UK biotechnology company focused on developing novel therapies for inflammation and autoimmune diseases, has been acquired by Arcutis Biotherapeutics. 8 September 2022
Industry analyst GlobalData has presented context on recently-approved inhalable coronavirus vaccines, indicating that the method of administration could be key to combating the spread of infections. 8 September 2022
Nodus Oncology has announced the completion of an asset purchase agreement (APA) for Basilea Pharmaceutica's novel poly (ADP-ribose) glycohydrolase (PARG) inhibitor discovery program. 8 September 2022
Health authorities in Europe have urged countries to use newly-authorized adapted COVID-19 vaccines as part of autumn and winter vaccination campaigns. 7 September 2022
Privately-held Seattle, USA-based drug developer Good Therapeutics says it has entered into a definitive agreement to be acquired by Swiss pharma giant Roche. 7 September 2022
California’s Arsenal Biosciences, a privately-held programmable cell therapy company engineering advanced CAR-T therapies for solid tumors, has closed a $220 million Series B financing. 7 September 2022
Based in Cambridge, Massachusetts, USA, Orbital Therapeutics launched today with a vision of enhancing global health by unleashing the full potential of RNA medicines to treat human disease in ways that were not previously possible. 7 September 2022
US biotech Rhythm Pharmaceuticals yesterday announced that the European Commission (EC) has expanded the marketing authorization for Imcivree (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients six years of age and older. 7 September 2022
Belgium’s largest pharma company UCB has announced new three-year results from the BE BRIGHT open-label extension study of bimekizumab. 7 September 2022
The European Commission (EC) has approved CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL), developed by Kite, a part of Gilead Sciences. 7 September 2022
Results from the DESTINATION Phase III extension trial showed Tezspire (tezepelumab) demonstrated an overall long-term safety and efficacy profile consistent with the previous PATHWAY Phase II and NAVIGATOR Phase III trials, sustained over 104 weeks in a broad population of patients with severe asthma. 7 September 2022