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 biopharma Sage Therapeutics looks all but certain to secure US approval for Zulresso (brexanolone) in postpartum depression after Food and Drug Administration (FDA) advisory committees supported its benefit-risk profile by 17 votes to one. 5 November 2018
The US Food and Drug Administration has approved Lorbrena (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI). 5 November 2018
With 26 potential blockbusters in confirmatory development and 13 projects in clinical development across cell, gene and radioligand therapies, Swiss pharma giant Novartis says it plans to make 60 major regulatory submissions between 2019 and 2021. 5 November 2018
Despite the disappointing history of drug development in pancreatic cancer, the current therapeutic pipeline and clinical development is headed in a promising direction, a new report notes. 5 November 2018
Embark Biotech and Novo Nordisk have joined forces in a new collaboration to develop treatments for obesity and associated metabolic pathologies. 2 November 2018
US drugmaker AbbVie has seen enough promise from its collaboration with Swedish biotech BioArctic (STO: BIOA-B) to exercise its option to license a portfolio of antibodies. 2 November 2018
An abstract published by Actinium Pharmaceuticals in advance of the American Society of Hematology (ASH) meeting in December indicates dramatic results for Iomab-B in from the preliminary safety and feasibility readout from its on-going SIERRA pivotal Phase III trial in R/R AML (relapsed/refractory acute myeloid leukemia), comments Dr Chris Redhead, an analyst at Goetzpartners. 2 November 2018
London-listed rare disease specialist Shire has released its third quarter results, revealing sales of $3.8 billion, in line with analysts’ expectations, and 6% higher than the same period in 2017. 1 November 2018
This morning abstracts for the American Society of Hematology (ASH) meeting became available online, showing data from the Phase III luspatercept studies in myelodysplastic syndromes (MDS) and beta-thalassemia that were not previously disclosed in the top-line press releases by Celgene. 1 November 2018
Fresh from presenting some of the most encouraging quarterly results in recent memory, Sanofi has taken another bet on increasing its future revenues. 1 November 2018
The Australian government has made a new medicine available, from today, for free for an extremely rare and potentially life-threatening disease, saving patients hundreds of thousands of dollars a year. 1 November 2018
The European Commission has approved Venclyxto (venetoclax) in combination with MabThera (rituximab) for chronic lymphocytic leukemia (CLL) patients who have received at least one prior therapy. 1 November 2018
USA-based cancer therapy discoverer Tango Therapeutics has entered into a global strategic collaboration to discover, develop and commercialize a pipeline of innovative targeted immuno-oncology treatments for patients with cancer which could earn the venture capital-backed firm $1.75 billion. 31 October 2018
Signalling its intention to grow its biopharma business in the USA, Danish diabetes giant Novo Nordisk (NOV: N) has bought the US and Canadian rights to Macrilen (macimorelin), from Strongbridge Biopharma. 31 October 2018
A UK government report on trends in the life sciences from 2009 to 2017 has found that the sector was broadly characterized by steady growth in terms of business numbers, jobs and turnover. 30 October 2018
In yet another deal with the Swiss pharma giant, US biotech Halozyme Therapeutics has licensed its ENHANZE drug-delivery technology to Roche for exclusive development of a new undisclosed clinical stage therapeutic target, with an option to select two additional targets within four years. 30 October 2018
Evidence of an effective new treatment for Alzheimer’s would create shock waves across healthcare, given the extent of the global need among millions of patients. 30 October 2018