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 biotech major Amgen’s Aimovig (erenumab) is forecast to be the top-selling drug in the migraine market by 2026, generating nearly $1.4 billion in sales in the seven major markets. 11 June 2018
Experts from the International Society for Cell and Gene Therapy (ISCT) told The Pharma Letter last month that the last 12 months had been the most important yet for advances in their field. 10 June 2018
The European Commission (EC) has approved a new indication for Prolia (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. 8 June 2018
In its Final Evidence Report and Report-at-a-Glance on cystic fibrosis transmembrane conductance regulator (CFTR) modulators, US health technology accessor the Institute for Clinical and Economic Review, calls for restraint and increased transparency in the pricing of three new cystic fibrosis drugs. 8 June 2018
The US Food and Drug Administration has approved Rituxan (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV). 8 June 2018
Biotech start-up Invenra recently announced a partnership collaboration with fellow USA-based Exelixis to develop multi-specific antibodies as cancer therapies. 8 June 2018
China's Luye Pharma has partnered up with US biotech firm Elpis Biopharmaceuticals to work on dual target based therapies for cancer patients who fail to respond to current treatment. 7 June 2018
BioMarin Pharmaceutical says it has received $20 million in milestone payments as a result of regulatory progress for its out-licensed breast cancer compound. 7 June 2018
Detailing his agency’s efforts to advance biotech innovation, US Food and Drug Administration Commissioner Scott Gottlieb has outlined key areas in which he intends to develop FDA policies and practices. 7 June 2018
US biotech Vertex Pharmaceuticals today announced 10 scientific abstracts from the company’s portfolio of cystic fibrosis (CF) medicines are being presented at the 41st European Cystic Fibrosis Conference taking place June 6-9, 2018, in Belgrade, Serbia. 7 June 2018
UK gene and cell therapy group Oxford BioMedica saw its share price leap more than 19% to 862.40 pence today, after it announced a lucrative deal to commercialize its Parkinson’s disease candidate, which could be worth as much as $824 million. 6 June 2018
Microbiotica, a researcher in microbiome-based therapeutics spun out of the UK’s Wellcome Sanger Institute, has agreed a multi-year strategic collaboration with the Roche unit Genentech to discover, develop and commercialize biomarkers, targets and medicines for inflammatory bowel disease (IBD). 6 June 2018
The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra (emicizumab-kxwh) for adults and children with hemophilia A without factor VIII inhibitors, an indication that would attract a much wider patient population than currently available. 6 June 2018
The recent US Food and Drug Administration approval for Cimzia (certolizumab pegol) marks Belgian drugmaker UCB’s entrance into the immuno-dermatology market, a competitive field in which Cimzia could find a niche space. 6 June 2018