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
The US Food and Drug Administration (FDA) has posted a safety communication to inform the public and healthcare providers that the agency has required and approved labeling changes to the US Prescribing Information (USPI) for all licensed BCMA-directed and CD19-directed genetically modified autologous CAR-T cell immunotherapies. 20 April 2024
Swiss drugmaker Ferring Pharmaceuticals has inked a deal with South Korean contract manufacturing and development organization (CDMO) SK pharmteco. 19 April 2024
Connecticut, USA-based biotech company Biohaven has priced an underwritten public offering with the goal of raising approximately $230 million. 19 April 2024
Dutch rare diseases biotech firm ProQR Therapeutics saw its shares leap more than 11% to $2.07 today, after it announced its successful defense against opposition filed against a key patent for its ADAR-mediated RNA editing platform Axiomer. 19 April 2024
Japanese drugmaker Chugai today announced that it concluded a license agreement with its majority owner, Swiss pharma giant Roche, for zilebesiran, 19 April 2024
Former Novartis executive Aurelia Caparrós has joined Amarna Therapeutics, a privately-held Dutch biotech developing gene therapies in a range of rare and prevalent diseases, including type 1 diabetes. 19 April 2024
A rare success in Parkinson’s disease is good news not just for the company behind the research - Cerevel Therapeutics - but also for AbbVie. 19 April 2024
Japanese pharma giant Takeda has picked up a new approval for subcutaneous Entyvio (vedolizumab), for maintenance therapy of severely active Crohn’s disease. 19 April 2024
US immune therapies and vaccines developer Corner Therapeutics has raised $54 million to create vaccines that confer lifelong protection from cancer and infectious diseases. 19 April 2024
American biopharma companies have criticised new European pharmaceutical legislation designed to make medicines more available, accessible and affordable. 18 April 2024
US pharma major Eli Lilly is on the brink of reshaping the pharmaceutical landscape with its ground-breaking treatments, Mounjaro (tirzepatide) for diabetes and marketed as Zepbound for obesity and the highly anticipated donanemab for early symptomatic Alzheimer’s disease. 17 April 2024
Swiss pharma giant Roche today released new data from the Phase III OCARINA II study (S31.006) of Ocrevus (ocrelizumab), an investigational twice-yearly, 10-minute subcutaneous (SC) injection. 17 April 2024
Ahead of a planned presentation at the American Thoracic Society meeting next month, US biotech major Amgen has released an update regarding the results of the Phase IIa COURSE trial for Tezspire (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), 17 April 2024
US privately-held Kumquat Biosciences today announced a strategic and exclusive collaboration with Japan’s Takeda to develop and commercialize a novel immuno-oncology (I-O) small molecule inhibitor as a mono- and/or combination-therapy. 17 April 2024
Novartis has announced data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta (ofatumumab) treatment for up to six years in recently diagnosed treatment-naïve people living with relapsing multiple sclerosis (RMS). 17 April 2024
A change of therapeutic focus, a full rebrand and a major cash injection will shake things up considerably at Massachusetts, USA-based Cullinan Therapeutics. 17 April 2024
North Carolina, USA-based KBI Biopharma has appointed Jean-Baptiste Agnus as chief business officer, joining the company’s executive team. 17 April 2024
US clinical-stage cell therapy developer Vittoria Biotherapeutics has announced that Keith Westby has joined the company as its inaugural chief operating officer (COO). 16 April 2024