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
Chicago’s AbbVie has submitted to the US regulator for approval to market Rinvoq (upadacitinib) for people with active ankylosing spondylitis (AS). 25 August 2020
Privately-held Engitix, a biotech developing programs in fibrosis and solid tumors using its proprietary human extracellular matrix (ECM) platform, has entered into a licensing and collaboration agreement with Japanese pharma major Takeda. 25 August 2020
With rates of COVID-19 infection continuing to climb worldwide, and a proven vaccine still at least months away, the value of therapeutic options under development is increasing. 25 August 2020
US oncology specialist Onconova saw its shares decimated after it announced that INSPIRE, the company’s pivotal Phase III study assessing the efficacy and safety of IV rigosertib in higher-risk myelodysplastic syndrome (HR-MDS) patients, did not meet its primary endpoint of improved survival. 25 August 2020
Vaccine research specialist Intravacc has partnered with Therapyx, a company based in Buffalo, New York, on development of the gonorrhea vaccine candidate NGoXIM. 25 August 2020
US biotech Moderna has concluded advanced exploratory talks with the European Commission (EC) to supply 80 million doses of mRNA-1273, its vaccine candidate against COVID-19. 24 August 2020
Bristol Myers Squibb has entered into a definitive agreement to acquire Forbius, a privately held, clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases. 24 August 2020
The Phase III COMBI-i study evaluating the immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar (dabrafenib) and Mekinist (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival. 22 August 2020
US biotech major Gilead Sciences and co-developer Belgium-based Galapagos received a big shock following the Food and Drug Administration’s complete response letter (CRL) for its rheumatoid arthritis (RA) candidate filgotinib earlier this week. 21 August 2020
The European Commission has approved Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor for cystic fibrosis (CF) patients aged 12 and older with one F508del mutation and one minimal function mutation (F/MF), or two F508del mutations (F/F) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 21 August 2020
Japan’s Ono Pharmaceutical has received a supplemental approval for Velexbru (tirabrutinib) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, in Japan for additional indication of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma, for a partial change in approved items of the manufacturing and marketing approval. 21 August 2020
Shares in German company BioNTech and US pharma giant Pfizer are both set to open Friday’s training with significant gains after the latest update on their COVID-19 vaccine. 21 August 2020
The US Food and Drug Administration has approved Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 21 August 2020
The US Food and Drug Administration has approved the expansion of the Kyprolis (carfilzomib) US prescribing information to include its use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly — for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three previous lines of therapy. 21 August 2020
UK pharma major AstraZeneca has secured approval in Japan for Imfinzi (durvalumab) as a treatment for extensive-stage small cell lung cancer (ES-SCLC). 21 August 2020
Tokyo’s Chugai Pharmaceutical has secured a label update for Kadcyla (trastuzumab) from the Japanese Ministry of Health, Labour and Welfare. 21 August 2020
Clinical-stage German biotech CureVac saw its shares rise 16% on Thursday and a further 6% to $70.00 pre-market today after it was revealed that the company had concluded exploratory talks with the European Commission with respect to the purchase of its investigational vaccine against COVID-19. 21 August 2020