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
The HOPE trial - together with a clinical mechanism of action study - strengthens the case for Lundbeck's Lu AG09222, as additional data highlights the anti-pituitary adenylate cyclase-activating polypeptide (PACAP) monoclonal antibody (mAb) as a potential preventive treatment for migraine. 14 September 2023
US clinical-stage immune-oncology firm Harpoon Therapeutics yesterday revealed that AbbVie has decided not exercise its exclusive license option in connection with Harpoon’s HPN217 program, which targets B cell maturation antigen, or BCMA. 14 September 2023
US biopharma firm Eiger BioPharmaceuticals saw its shares plummet more than 40% to $0.41, after it announced its decision to discontinue the Phase III LIMT-2c study of peginterferon lambda in patients with chronic hepatitis delta (CHD). 14 September 2023
French immuno-oncology specialist OSE Immunotherapeutics has announced that the results from its Phase III trial (ATALANTE-1) for Tedopi (OSE: 2101) have been published in Annals of Oncology. 14 September 2023
Stock in New Jersey, USA-based Rocket Pharmaceuticals shot up around 40% on Wednesday, following good news on the financing and regulatory fronts. 14 September 2023
In France, a recently-founded biotech focused on the tumor microenvironment has agreed terms for a licensing and co-development program with SATT Nord. 14 September 2023
Shares of London-listed blood disease specialist Hemogenyx Pharmaceuticals were up more than 9% at 1.80 pence, after it revealed in a stock exchange filing a positive development for its investigational product. 14 September 2023
Taiwan-based BRIM Biotechnology today announced that 22,500 shares have been issued at a premium of NT$65 (~US$2.03), raising a total of NT$1.4625 billion (~US$45.8 million). 13 September 2023
US biotech Moderna has spent much of the last couple of years banging the drum about the potential of its mRNA platform beyond producing the COVID-19 vaccine that brought the company multi-billion dollar sales and global acclaim. 13 September 2023
US pharma major AbbVie has scored another success with its next-generation anti-inflammation drug Skyrizi (risankizumab), with new data showing its drug matched, and even exceeded, the performance of a rival in the treatment of Crohn’s disease. 13 September 2023
The US Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) for Altuviiio [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl]. 13 September 2023
US biotech start-up Septerna says it has signed a definitive asset purchase agreement with Vertex Pharmaceuticals under which Vertex has acquired an undisclosed discovery-stage GPCR program. 13 September 2023
Dermatology and cosmetics company Pierre Fabre Laboratories has bought oncology specialist Vertical Bio, thus adding VERT-002 to its discovery pipeline. 12 September 2023
US cell and gene therapy biotech 2seventy bio had a bumpy ride this morning, after it announced a restructuring of its business operations and research and development model to significantly reduce costs while supporting the execution of a prioritized plan for the long-term growth of the company. 12 September 2023
Neurocrine Biosciences saw its shares rise 6.4% to $115.50 this morning, as it announced positive top-line data from the Phase III CAHtalyst Adult Study. 12 September 2023
Chinese biopharma Hutchmed today announced positive results from the confirmatory Phase IIIb clinical trial of savolitinib in patients with mesenchymal epithelial transition factor (MET) exon 14 skipping alteration non-small cell lung cancer (NSCLC). 12 September 2023
People with eosinophilic granulomatosis with polyangiitis (EGPA) could benefit from a convenient monthly injection of Fasenra (benralizumab), according to new data. 12 September 2023
Privately-held Swedish firm Salipro Biotech has entered into a research collaboration with Japan's Sumitomo Pharma to reveal the mechanism of action and pharmacological characterization of a drug candidate. 12 September 2023