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
The Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing whether JAK inhibitors offer value for money for the treatment of rheumatoid arthritis in the USA, at the same time as publishing recommendations on how to stop the current 'upward trajectory' of drug prices. 10 January 2020
The US Food and Drug Administration has approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. 10 January 2020
US hematopoietic cell transplant therapies focussed biotech Jasper Therapeutics has expanded its Series A financing with an additional investment of $14.1 million led by Roche Venture Fund and with participation from other investors, bringing the total company financing to more than $50 million to date. 10 January 2020
Further replenishing its R&D pipeline in the face of falling sales for some its blockbuster anti-viral drugs and an aging HIV portfolio, Gilead Sciences has licensed The Rockefeller University’s portfolio of broadly neutralizing antibodies (bNAbs) against HIV, including the two clinical-stage agents 3BNC117 and 10-1074. 9 January 2020
German family-owned pharma major says it has entered into a worldwide exclusive license deal to acquire Singapore-based biotech Enleofen Bio’s pre-clinical interleukin-11 (IL-11) platform to develop first-in-class therapies across a broad range of fibro-inflammatory diseases. 9 January 2020
Germany’s BioMed X has unveiled a new joint research group, in collaboration with Merck KGaA, the sixth such collaborative project between the two companies. 9 January 2020
Shares in French peanut allergy specialist DBV Technologies were boosted 20% in pre-market trading on Thursday, after the firm announced positive topline results from the Phase III PEPITES trial. 9 January 2020
The US regulator has added another approval to the list for Merck & Co’s Keytruda (pembrolizumab), as monotherapy for certain people with non-muscle invasive bladder cancer (NMIBC). 9 January 2020
Altavant Sciences has entered into a definitive agreement to acquire USA-based Onspira Therapeutics, a private drug development company similarly focused on therapeutics for rare pulmonary diseases. 9 January 2020
US biopharma Immunic has opted to exercise an exclusive global option to license a group of compounds, designated as IMU-856, from Daiichi Sankyo. 8 January 2020
Japanese drugmaker Kyowa Kirin today said that it has submitted a supplemental application for Lumicef (brodalumab) for the treatment of axial spondyloarthritis (axSpA) in Japan. 8 January 2020
UK-based Avacta Group and Korean pharma Daewoong Pharmaceutical are to form a joint venture (JV) aimed at developing cell and gene therapies incorporating the Cambridge-based company’s Affimer proteins. 8 January 2020
A new collaboration between Aragen Bioscience and Serum Institute of India will see the development of multiple stable cell lines in support of the latter’s HIV program. 8 January 2020
Spain’s largest drugmaker could be about to get bigger with the news that Almirall has entered into an option agreement to buy Bioniz Therapeutics to further expand its pipeline in dermatology. 8 January 2020