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
After several US setbacks affecting the firm’s lead product, AVEO Oncology late Wednesday finally received US Food and Drug Administration approval for Fotivda (tivozanib) as a treatment of adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies. 11 March 2021
Roche today revealed that the global Phase III randomized, double-blind, multicenter REMDACTA study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir), versus placebo plus Veklury, did not meet its primary endpoint. 11 March 2021
Shares of US biotech bluebird bio gained 13% pre-market today and were still up 8.8% at $32.70 by mid-morning after it announced encouraging analyses of its gene therapy program that was linked with a serious adverse event. 10 March 2021
Belgium’s AgomAb Therapeutics says it has closed a $74 million Series B financing round led by Redmile Group, which will further advance its lead compound AGMB-101. 10 March 2021
Novartis has announced that the Phase III CANOPY-2 study evaluating canakinumab in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival. 10 March 2021
Hong Kong-based Uni-Bio Science Group closed up 2% at HK$0.10 today, after it revealed it has formed a partnership with Singapore’s DotBio to co-develop next generation, best-in-class therapeutics for patients with retinal diseases. 10 March 2021
Drug delivery innovator TFF Pharmaceuticals, a biotech company based in Texas, has entered into two new collaborations exploring the use of its technology. 10 March 2021
Shares of US gene therapy company Rocket Pharmaceuticals were up more than 9% at $53.14 in early afternoon trading on Tuesday, after the company revealed that the Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-L201, its investigational gene therapy for the treatment of leukocyte adhesion deficiency-I (LAD-I). 10 March 2021
Orionis Biosciences, a privately-held genome-scale drug discovery company, and The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division, have announced the launch of a research collaboration. 9 March 2021
New Jersey, USA-based rare disease drug developer PTC Therapeutics today announced that it will provide an initial funding of $60 million to the Spinal Muscular Atrophy (SMA) Foundation to discover and develop regenerative medicines for neuromuscular diseases to help restore patients lost function. 9 March 2021
Spanish drugmaker Grifols today announced the closing of its agreement with GigaGen to acquire its remaining 56% share capital for $80 million. 9 March 2021
Japanese drugmaker Takeda has announced the exercise of its option to acquire Maverick Therapeutics, a private biopharma company pioneering conditionally active bispecific T-cell targeted immunotherapies. 9 March 2021
US biotech Soleno Therapeutics has provided an update following recent interactions with the US Food and Drug Administration regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi Syndrome (PWS). 9 March 2021
USA and Canada-based biotech CytoDyn, which is developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, yesterday reported the Phase III trial of leronlimab for the treatment of severe-to-critical patients with COVID-19. 9 March 2021
Clarivate today announced the launch of its annual "Drugs to Watch" list, identifying drugs entering the market or launching key indications in 2021 which are predicted to achieve blockbuster status by 2025. 9 March 2021
Lab research published in the New England Journal of Medicine suggests that Comirnaty, the coronavirus vaccine developed by BioNTech and Pfizer, could be effective against a Brazilian variant of concern. 9 March 2021
Genomics-based drug discovery company Exelixis has announced an exclusive license agreement with WuXi Bio to support the continued expansion of its oncology biologics pipeline. 8 March 2021
The UK's National Health Service (NHS) has fast-tracked the introduction of Novartis’ Zolgensma (onasemnogene abeparvovec) to make it available for babies and young children with spinal muscular atrophy (SMA). 8 March 2021