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
Swiss pharma giant Roche has presented data from the largest pivotal study to date in children with hemophilia A at the American Society of Hematology Annual Meeting. 4 December 2018
German biotech Evotec has entered into a new integrated drug discovery alliance with Denmark’s LEO Pharma, a global leader in medical dermatology, adding to a string of deals the German company has signed this year. 4 December 2018
BeiGene clinical data from the pivotal Phase II trial of its investigational anti-PD-1 antibody, tislelizumab, in Chinese patients with relapsed/refractory (R/R) classical Hodgkin’s lymphoma (cHL), at the Annual Meeting of the American Society of Hematology (ASH) yesterday. 4 December 2018
Japanese biopharma Sosei Group has announced a re-branding and re-launching of its main operating business, three years after paying $400 million for Heptares Therapeutics’ G protein-coupled receptor pipeline. 3 December 2018
UK Research and Innovation (UKRI) has announced it will build a new Vaccines Manufacturing Innovation Centre, aimed at addressing a “structural gap in late-stage vaccine manufacturing process development.” 3 December 2018
There has been much speculation in recent weeks that US drugmaker and PARP inhibitor specialist Tesaro had put itself up for sale that has already sent the firm’s shares higher, but today they leapt more than 59% to $73.95 in pre-market trading after it was revealed that it has reached agreement to be taken over. 3 December 2018
US biotech firm Seattle Genetics’ shares gained 2.75% to $64.3-in pre-market trading today, after it highlighted data from the ECHELON-1 Phase III clinical trial evaluating Adcetris (brentuximab vedotin) at the ASH meeting. 3 December 2018
China’s BeiGene on Saturday announced clinical data from two ongoing trials of its investigational Bruton’s tyrosine kinase (BTK) inhibitor, zanubrutinib, in patients with mantle cell lymphoma (MCL), at the 60th Annual Meeting of the American Society of Hematology (ASH), taking place December 1-4, 2018 in San Diego, USA. 3 December 2018
Gilead Sciences company Kite Pharma released positive two-year efficacy and safety data from the pivotal ZUMA-1 trial of Yescarta (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. 3 December 2018
In a Phase III clinical trial, presented at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, USA, on the opening day, December 1, the experimental drug luspatercept significantly reduced the need for blood transfusions in patients with the inherited blood disorder beta thalassemia. 2 December 2018
Ireland-incorporated rare disease specialist Shire has been granted European approval for Takhzyro (lanadelumab) for routine prevention of attacks of hereditary angioedema (HAE), a rare, genetic and potentially life-threatening disorder. 30 November 2018
Bristol-Myers Squibb has entered a collaboration with two UK partners that comes with the promise of creating a ‘rule book’ to guide precision combination immunotherapies and to speed up the development of new lung cancer treatments. 30 November 2018
UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending the reimbursement within the Cancer Drugs Fund (CDF) of the immunotherapy, Opdivo (nivolumab), as adjuvant treatment after surgery, to potentially keep the cancer from returning. 30 November 2018
The growth of Chinese biopharma Hutchinson China MediTech took a dent earlier in the month with the share-damaging news of a Phase III failure of fruquintinib, a drug that has just been approved in China to treat advanced colorectal cancer. 29 November 2018
The US Food and Drug Administration on Wednesday approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. 29 November 2018
The US Food and Drug Administration has given Catalyst Pharmaceuticals approval for Firdapse (amifampridine), a therapy for the rare disease Lambert-Eaton myasthenic syndrome (LEMS). 29 November 2018
Charlotte Tillett, partner, and Emily Hocken, trainee, at Stevens & Bolton, offer an Expert View on the significance of the UK Supreme Court ruling in Warner-Lambert (WL) v Generics relating to WL’s best-selling pain relief drug, Lyrica (pregabalin). 28 November 2018
Hookipa Pharma has entered into a research collaboration and license agreement with DarwinHealth to develop novel immunotherapies based on the systematic discovery and prioritization of the next generation of immunogenic, tumor-specific cryptic antigens. 28 November 2018
The marketing drive for Shire’s Takhzyro (lanadelumab) has had a boost as the company seeks to convince payers that its hefty price tag is worth paying. 28 November 2018
US gene therapy company Rocket Pharmaceuticals yesterday announced that the US Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) and fast track designations to RP-L102, the company’s lentiviral vector (LVV)-based gene therapy for the treatment of Fanconi anemia (FA). 28 November 2018