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
Swiss cancer giant Roche has outlined the data it intends to present at the upcoming annual meeting of the European Society for Medical Oncology (ESMO). 23 September 2019
In a surprise change of leadership at Akcea Therapeutics, Paula Soteropoulos, chief executive, Sarah Boyce, president, and Jeff Goldberg, chief operating officer, have all resigned with immediate effect. 23 September 2019
China-based biotech CARsgen Therapeutics has been granted PRIority MEdicines (PRIME) eligibility to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of relapsed or refractory multiple myeloma, by the European Medicines Agency 23 September 2019
As well as recommending approval of four novel medicines and three generic medicines at its September 2019 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced positive opinions for a number of label extensions, as follows: 23 September 2019
Japanese drugmaker JCR Pharmaceuticals has withdrawn its application with the Ministry of Health, Labor and Welfare of Japan (MHLW) for additional marketing approval of Temcell HS Inj, allogeneic bone marrow-derived mesenchymal stem cells, for the indication of epidermolysis bullosa (EB) (development code: JR-031EB). 20 September 2019
On Thursday, US House of Representatives Speaker Nancy Pelosi unveiled drastic proposals that would allow Medicare to negotiate lower prices on as many as 250 drugs and apply those discounts to private health plans. 19 September 2019
The full results of Strongbridge Biopharma’s Phase III SONICS study of the use of Recorlev (levoketoconazole) in endogenous Cushing’s syndrome have been published online in The Lancet Diabetes & Endocrinology. 19 September 2019
Bristol-Myers Squibb has outlined the data it will present at this year’s annual meeting of the European Society for Medical Oncology (ESMO), in Barcelona. 19 September 2019
New research examining the impact of antibiotics suggests that fluoroquinolones could create an elevated risk of developing aortic and mitral regurgitation, serious heart problems. 19 September 2019
A new report from industry analyst GlobalData finds that the market for hidradenitis suppurativa (HS) therapies is expected to grow from $898 million in 2018 to $1.81 billion in 2028, across the major markets. 19 September 2019
Privately-held oncology specialist Rgenix says that Robert Wasserman, has joined the Rgenix management team as its new chief medical officer. 19 September 2019
,veXis today announced that new interim data from the Phase III SPR1NT trial in pre-symptomatic patients as well as interim data from the ongoing Phase III STR1VE clinical program for Zolgensma (onasemnogene abeparvovec-xioi) showed positive outcomes, demonstrating age appropriate major milestone gain with pre symptomatic treatment and prolonged event-free survival* in patients with spinal muscular atrophy (SMA) Type 1. 19 September 2019
The US Food and Drug Administration has approved Erleada (apalutamide), from Johnson & Johnson subsidiary Janssen Biotech, for patients with metastatic castration-sensitive prostate cancer (mCSPC). 18 September 2019
Data presented in a symposium session at the annual meeting of the European Association for the Study of Diabetes (EASD) provide insights into imeglimin, an investigational type 2 diabetes medicine. 18 September 2019
Shares of Alexion Pharmaceuticals dipped 1.3% to $106.44 in after-hours trading on Tuesday, after the US biotech company announced plans for the transition of executive vice president and chief financial officer Paul Clancy later this year. 18 September 2019