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 Daiichi Sankyo’s shares edged up nearly 2% to 4,426 yen today, after it announced it was giving up Japanese marketing rights to Yescarta (axicabtagene ciloleucel). 8 December 2022
Earlier this month, US President Biden told a Carlsbad, Calif. audience that America’s future rests on major breakthroughs in technology and science. “Other countries are closing in fast,” he elaborated. “The CHIPS and Science Act sets us on a path to move up again.” 8 December 2022
Swedish biotech Oncopeptides saw its shares plunge 36% to 12.00 Swedish kronor yesterday, after it revealed that the US Food and Drug Administration (FDA) has requested a withdrawal of the US marketing authorization for its multiple myeloma drug Pepaxto (melphalan flufenamide). 8 December 2022
US biotech Mammoth Biosciences, which is building the next generation of CRISPR products to cure and detect disease, has reinforced its C-suite with the arrival of two industry veterans - Phil Tinmouth as chief business officer, and Siang Chin as general counsel. 8 December 2022
The marketing authorization application (MAA) for momelotinib, an investigational oral treatment for myelofibrosis, submitted by UK pharma major GSK, has been accepted by the European Medicines Agency (EMA). 7 December 2022
Trodelvy (sacituzumab govitecan-hziy), an antibody-drug conjugate (ADC) developed by California’s Gilead Sciences, has performed well in a post hoc analysis of the Phase III TROPiCS-02 study. 7 December 2022
Massachusetts, USA-based Entact Bio, co-founded in 2019 by an international group of researchers to develop precision medicines that enhance the function of key proteins, announced it has raised $81 million in Series A financing to advance its proprietary Encompass platform for developing enhancement-targeting chimeric (ENTAC) molecules. 7 December 2022
Shares of US drugmaker Summit Therapeutics went stratospheric yesterday, rocketing 194% to $2.31 by close, after it announced a licensing deal with a Chinese drug developer that could cost it as much as $5 billion. 7 December 2022
Australian biotech CSL Limited today unveiled the future of plasma manufacturing in Australia with the opening of its A$900 million ($608 million) plasma fractionation facility in Victoria, which the company claims is the largest of its kind in the Southern Hemisphere. 7 December 2022
French firm Valneva has presented positive antibody persistence data 12 months after vaccination with a single dose of its chikungunya vaccine candidate, VLA1553. 6 December 2022
Ireland and USA-based natural killer (NK) cell therapy biotech ONK Therapeutics has named Bruce McCreedy as chief scientific officer (CSO). 6 December 2022
Shares of La Jolla USA-based biotech Equillium were up 12% to $1.85 in pre-market trading, on news of a lucrative licensing deal with Japan’s Ono Pharmaceutical. 6 December 2022
In a challenging environment for biotech finance, Australian needle-free treatment specialist Vaxxas has raised new money for its COVID-19 vaccine - a sign of its potential in the growing market for seasonal coronavirus protection. 6 December 2022
While autologous CAR-T cell therapies have upended the treatment landscape for people with blood cancer, associated toxicities have limited access for many people. 6 December 2022
US clinical-stage cancer focused biotech Mirati Therapeutics has announced preliminary results from the KRYSTAL-7 Phase II trial and KRYSTAL-1 Phase Ib cohort evaluating adagrasib (400mg twice daily) concurrently combined with Merck & Co’s blockbuster drug Keytruda (pembrolizumab) in patients for the treatment of first-line non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation across all PD-L1 subgroups. 6 December 2022
The US Food and Drug Administration (FDA) has approved a second indication for Brexafemme (ibrexafungerp tablets) for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC). 6 December 2022
Research from industry analyst GlobalData has highlighted the extent to which the market capitalization of the largest biopharmaceutical firms has declined in the last quarter. 5 December 2022
Patients have been dealt a major blow after the first ever treatment for AL amyloidosis, a rare incurable condition, was rejected by the UK’s National Institute for Health and Care Excellence (NICE). 5 December 2022