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
Roche unit Genentech has announced that the US Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for advanced ovarian cancer following initial surgical resection. 14 June 2018
On Wednesday, the Annual European Congress of Rheumatology (EULAR) kicked off in Amsterdam, with a series of presentations to look forward to from rheumatic disease heavyweights AbbVie, Johnson & Johnson, Pfizer and others. 13 June 2018
Data presented on the Folfirinox chemotherapy regimen at the American Society of Clinical Oncology (ASCO) has spelt the end for Targovax’s TG01, a neoantigen cancer vaccine for resected pancreatic cancer. 13 June 2018
Shares in Israeli biotech Galmed Pharmaceuticals closed more than 150% up on Tuesday after the company revealed results that hint at a new treatment in one of pharma’s hottest therapy areas. 13 June 2018
Biomedical companies in the Spanish Catalan region attracted 102 million euros ($120 million) in investment in 2017, with 3.4 million euros per operation, on average. 13 June 2018
Lev Gerlovin (pictured left) and Walter Colasante are vice presidents at the life sciences division of Charles River Associates. Writing for The Pharma Letter, they seek to address the challenges posed to the existing biopharma business model by revolutionary, but prohibitively expensive, cell and gene therapies. 13 June 2018
USA-based vTv Therapeutics saw its shares plunge 22.75% to $1.46 in pre-market trading after it revealed another disappointment in the development of its Alzheimer’s disease candidate, notching up another AD failure this week alone. 13 June 2018
Albireo Pharma, a USA-based biotechnology company spun out from Anglo-Swedish drug major AstraZeneca in 2008, announced on Tuesday that it has been granted Rare Pediatric disease designation by the FDA for A4250 for the treatment of progressive familial intrahepatic cholestasis (PFIC), a rare liver disease with no approved drug therapy. 13 June 2018
Things only get better and better for US pharma giant Merck & Co’ blockbuster cancer drug Keytruda (pembrolizumab), which just last week was seen to be the outstanding event at the American Society of Clinical Oncology (ASCO) meeting. 13 June 2018
At the Annual European Congress of Rheumatology (EULAR), Chicago’s AbbVie presented new data from Phase III trials evaluating upadacitinib. 13 June 2018
US drugmaker Alexion Pharmaceuticals has entered into a partnership with Dutch biotech Complement Pharma to co-develop the preclinical C6 complement inhibitor CP010 for neurodegenerative disorders. 12 June 2018
US clinical-stage biotech firm Regenxbio says it has received an accelerated license payment of $100 million under its license agreement with AveXis for the development and commercialization of products to treat spinal muscular atrophy (SMA). 12 June 2018
A vaccine has moved into a Phase I trial for patients with non-small cell lung cancer (NSCLC) in a collaboration between Californian biotech Asterias Biotherapeutics and the charity Cancer Research UK. 11 June 2018
China’s Zai Lab, a Shanghai-based innovative biopharmaceutical company, has appointed that William Liang as chief commercial officer, reporting to Dr Samantha Du, Zai Lab’s chief executive. 11 June 2018
China-based WuXi Biologics (HK: 2269) is to invest $60 million and hire approximately 150 employees to establish a state-of-the-art biologics clinical and commercial manufacturing facility in Worcester, Massachusetts in the USA. 11 June 2018
Privately-held Viennese firm Themis Bioscience has been awarded PRIME designation for its candidate chikungunya fever vaccine, unlocking enhanced regulatory support from the European medicines regulator. 11 June 2018
The world biggest-ever selling drug Humira (adalimumab), which has so far managed to stave off biosimilars competition, has now seen the launch of a new formulation in Japan. 11 June 2018
Danish diabetes giant Novo Nordisk is to fire 3,000 staff and reduce long-term growth projections, in an increasingly challenging pricing environment for insulin. 11 June 2018
On June 8, 2018, the Food and Drug Administration granted regular approval to Venclexta (venetoclax) in combination with Rituxan (rituximab) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. 11 June 2018