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
Japanese drug major Eisai’s shares closed up 6% at 12.075 yen today, as it revealed an exclusive global agreement with the USA’s Bristol Myers Squibb for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC), that could earn the company more than $3 billion. 18 June 2021
Dutch specialty pharma company Pharming Group said today it has appointed Anurag Relan as chief medical officer (CMO), effective immediately, and Robert Friesen as chief scientific officer, effective from August 1, 2021. 18 June 2021
US science and technology conglomerate Danaher Corporation has entered into a definitive agreement to acquire privately-held biotech firm Aldevron, a fast-growing producer of plasmid DNA, mRNA and recombinant proteins that are used for vaccines, including those for the current coronavirus pandemic. 18 June 2021
FibroGen and fellow USA-based HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science, have announced a partnership covering three HiFiBiO programs. 18 June 2021
Charnwood Molecular, a UK-based pre-clinical discovery contract research organization (CRO) has announced the acquisition of the assay development and biological screening provider, Aurelia Bioscience. 18 June 2021
Gilead Sciences’ subsidiary has announced a strategic partnership with privately held US biotech Shoreline Biosciences to develop novel cell therapies across a variety of cancer targets. 18 June 2021
Swiss pharma major Novartis has secured a positive reimbursement decision in the UK for Cosentyx (secukinumab) as an option for certain people with active non-radiographic axial spondyloarthritis. 17 June 2021
The Russia Ministry of Health of the Russian Federation has approved pathogenetic therapy of cytokine release syndrome in patients with moderate to severe new coronavirus infection (COVID-19) as an additional indication to be included in the olokizumab SmPC. 17 June 2021
Positive findings from the STOP-COVID study (NCT04469114) evaluating the efficacy and safety of oral Janus kinase (JAK) inhibitor tofacitinib in 289 hospitalized adult patients with COVID-19 pneumonia who were not on ventilation have been published in that the New England Journal of Medicine. 17 June 2021
The US government has purchased an additional 200 million doses of the coronavirus vaccine developed by Moderna, in case boosters are needed. 17 June 2021
In an environment with continued pricing pressure biopharma executives are asking themselves: Can we discover and develop new medicines that improve patient outcomes whilst solving access challenges? 17 June 2021
Having scored a historic first last week, with accelerated US regulatory approval for the use of its Aduhelm (aducanumab) as the first treatment in nearly two decades to address an underlying cause of Alzheimer's disease, yesterday US biotech major Biogen (Nasdaq: BIIB) also added to the list of failures in the search for such treatments. 17 June 2021
The US Food and Drug Administration approved Cambridge, Massachusetts-based Blueprint Medicines’ Ayvakit (avapritinib) for adult patients with advanced systemic mastocytosis (AdvSM). 17 June 2021
German vaccines developer CureVac saw its shares halve in value overnight, after the firm announced its coronavirus vaccine had failed late-stage testing. 17 June 2021
US biotech Regeneron Pharmaceuticals’ shares were up 2.4% at $40.16 in early trading today, as new results of a large UK clinical trial showed the company’s antibody cocktail improved survival in hospitalized COVID-19 patients. 16 June 2021
In a second cardiometabolic deal signed this month, Danish diabetes care giant Novo Nordisk has now entered into a collaboration with privately-held US biotech Lumen Bioscience. 16 June 2021
Japanese pharma major Daiichi Sankyo has pulled the plug on development of an inhaled formulation of nafamostat, dubbed DS-2319, as a treatment for COVID-19. 16 June 2021
Vyepti (eptinezumab-jjmr) met both co-primary endpoints of the RELIEF study, published today in the Journal of the American Medical Association (JAMA), showing early benefit for time to headache pain freedom, and time to the absence of most bothersome symptoms (MBS), compared to placebo, said Danish CNS specialist Lundbeck. 16 June 2021
Swiss-American biotech CRISPR Therapeutics and USA-based Capsida Biotherapeutics have entered into a strategic partnership to research, develop, manufacture and commercialize in vivo gene editing therapies delivered with engineered AAV vectors for the treatment of familial amyotrophic lateral sclerosis (ALS) and Friedreich’s ataxia. 15 June 2021
Biogen’s near-billion dollar bet on Nightstar Therapeutics looks set to lose spectacularly, following the failure of the Phase III STAR study of lead candidate timrepigene emparvovec. 15 June 2021