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
In the first-line kidney cancer setting, Germany’s Merck KGaA has thrown its hat firmly into the ring, with strong data from the JAVELIN Renal 101 trial showing the firm is ready to go toe to toe with its American namesake, and others. 22 October 2018
The International AIDS Vaccine Initiative (IAVI) and Serum Institute of India, the world's largest vaccine manufacturer, today announced a strategic partnership to develop and manufacture affordable and accessible monoclonal antibody products for HIV and other global health challenges. 22 October 2018
For the first time, an immuno-oncology therapy has been shown to be effective against breast cancer, new data highlighted at the annual ESMO congress have shown. 22 October 2018
Entyvio (vedolizumab), Takeda’s gut-selective biologic that is approved as an intravenous (IV) formulation for ulcerative colitis (UC) and Crohn’s disease (CD), could soon become available in subcutaneous (SC) form. 22 October 2018
The US Food and Drug Administration has approved Dupixent (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. 20 October 2018
Shares of US drugmaker Merrimack Pharmaceuticals were down 30.23% at $3.60 in pre-market trading today, after it announced the termination of the SHERLOC study. 19 October 2018
A new analysis of Lutathera (lutetium Lu 177 dotatate) NETTER-1 data has been presented at the 2018 European Society for Medical Oncology (ESMO) congress, which kicked off in Munich, Germany today, which examines the impact of Lutathera treatment on patients with low, medium or high liver tumor burden. 19 October 2018
The Parker Institute for Cancer Immunotherapy and Xyphos Biosciences today announced a collaboration to create universal CAR-T therapies to treat multiple cancer types using the company's 'convertibleCAR' platform. 18 October 2018
There was good news for two US majors with novel CGRP inhibitor migraine prevention drugs, but disappointment for another firm, when US pharmacy benefits manager (PBM) Express Scripts yesterday announced its new SafeGuardRx Migraine Care Value program, which will begin April 1, 2019. 18 October 2018
Japan’s Sosei has announced that it will not take up an option to acquire more equity in MiNA Therapeutics, the British RNA activation therapeutics company. 18 October 2018
Gilead Sciences is to collaborate with Spain's AELIX Therapeutics, a spin-off of the HIVACAT vaccine research consortium, on the development of investigational products aimed at curing HIV infection. 18 October 2018
Sweden’s Medivir says it will reduce activities “not critical to its development pipeline of drug candidates,” including cutting around 60 staff, as part of a cost-cutting plan. 17 October 2018
The US Food and Drug Administration approved Talzenna (talazoparib), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer. 17 October 2018
Intrathecal catheterization is a highly effective delivery method for drugs targeting neurological diseases, writes Brad Gien, head of surgery, North America, Envigo, in an Expert View piece. 17 October 2018
US Food and Drug Administration Commissioner Scott Gottlieb has issued a statement outlining the steps his agency is taking to modernize programs and “advance opportunities for developing more targeted therapies.” 16 October 2018
Chinese biotech Innovent Biologics wants to raise $422 million in an initial public offering (IPO) to take forward its monoclonal antibodies and other biologics in oncology, ophthalmology, autoimmune, and cardiovascular diseases. 16 October 2018
After already penning two licensing deals in the past few months, HiFiBiO Therapeutics has today announced the acquisition of H-Immune Therapeutics, an early-stage biotechnology company engaged in the discovery and development of novel immuno-oncology therapeutics. 16 October 2018
Roche might be facing increased competition to its well-established breast cancer drug Herceptin (trastuzumab), but the Swiss pharma giant is not sitting still as biosimilars start to take market share. 16 October 2018