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
Shares of US biotech Stealth BioTherapeutics leapt 28% to $8.20 in pre-market trading today, after it announced an agreement for an option to co-develop and commercialize elamipretide for mitochondrial diseases with Alexion Pharmaceuticals. 10 October 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation to Ofev (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. 10 October 2019
US biotech firm Ra Pharmaceutical saw its shares roar ahead 103% to $46.14 in pre-market trading today, on the news that it has agreed to a takeover by Belgium’s largest pharma firm UCB. 10 October 2019
Hutchison China MediTech Limited, also known as Chi-Med, has expanded its global collaboration with fellow Chinese firm Innovent Biologics. 10 October 2019
Hong Kong-based Insilico Medicine, a company developing an end-to-end drug discovery pipeline utilizing the latest advances in deep learning, has entered into a two-program AI drug discovery collaboration agreement with Jiangsu Chia Tai Fenghai Pharmaceutical (CTFH), taking on previously undruggable targets. 9 October 2019
A new research collaboration between Danish diabetes giant Novo Nordisk and the Cambridge, USA-based firm bluebird bio will see the companies work together on certain in vivo gene editing technologies. 9 October 2019
Collaboration will be crucial to keeping up with growing consumer demand for microbiome support, writes David Evendon-Challis, vice president of innovation at the consumer goods firm, RB, in an Expert View piece. 9 October 2019
The US regulator has finally approved Scenesse (afamelanotide), a subcutaneous implant used to treat the ultra-rare disorder erythropoietic protoporphyria, in which exposure to sunlight causes pain. 9 October 2019
UK-based biotech firm Prokarium says it has received an investment of £4.59 million ($5.6 million) from the Wellcome Trust to fund two clinical trials of its lead program, Entervax, a bivalent vaccine against enteric fever. 9 October 2019
Basel-based drugmaker Novartis has provided a detailed look at the data propelling late stage development of ligelizumab, a possible replacement for the ageing respiratory drug Xolair (omalizumab). 8 October 2019
The growing stable of Flagship Pioneering now has another member, with this one purportedly the world’s first exoneural biology company. 8 October 2019
GlaxoSmithKline today announced a five-year collaboration with California, USA-based biotech Lyell Immunopharma, to develop new technologies to improve cell therapies for cancer patients. 8 October 2019
Handan He has left her role as global head of computational, biopharmaceutics and translational PK/PD at Novartis’ pharma unit to join Ascletis as chief scientific officer. 8 October 2019
There were two important drug approvals for medicines regulator Health Canada today, the first being US biotech major Amgen’s new humanized anti-sclerostin monoclonal antibody for osteoporosis. 8 October 2019
US biotech major Gilead Sciences yesterday announced that the New Drug Application (NDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis (RA), has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW). 8 October 2019
Shares in South Korean biotech Helixmith are up by more than half after the firm announced results for a first-in-class biologic, VM202. 8 October 2019
With its leading ophthalmology drug Lucentis (ranibizumab) nearing the end of its patent exclusivity, there was good news for Swiss pharma giant Novartis with US regulatory approval for its successor. 8 October 2019
US biotech Sarepta Therapeutics lost more than 50% of its market value between mid-July and last week, with an adverse event report and a US Food and Drug Administration (FDA) rejection of Vyondys 53 (golodirsen) contributing to the damage. 7 October 2019