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
Switzerland-based biotech firm Numab Therapeutics has entered into a research collaboration and worldwide licensing agreement with German family-owned pharma Boehringer Ingelheim. 7 July 2020
Immuno-oncology start-up Vor Biopharma, which is pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, today announced it has raised $110 million in a Series B financing. 7 July 2020
US biotech firm Regeneron Pharmaceuticals saw its shares rise 4.6% on Monday and gain a further 3.6% to $650.03 by mid-morning today, after it announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron's investigational double antibody cocktail for the treatment and prevention of COVID-19, as well as a lucrative deal with the US government. 7 July 2020
The European Investment Bank (EIB) and CureVac, a clinical-stage German biotech company developing a new class of transformative medicines based on optimised mRNA, entered into a 75 million-euros ($84 million) loan agreement to support the company’s ongoing development of vaccines against infectious diseases, including its vaccine candidate CVnCoV aimed at preventing SARS-CoV-2 infections. 7 July 2020
Shares in Immunomedics were lifted 8% on Monday, after the antibody-drug conjugate (ADC) specialist posted positive data from the Phase III ASCENT study of Trodelvy (sacituzumab govitecan-hziy). 7 July 2020
Emergent BioSolutions has announced a five-year manufacturing services agreement with Janssen Pharmaceuticals, part of US healthcare giant Johnson & Johnson, for large-scale drug substance manufacturing for J&J’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant based on the AdVac technology. 7 July 2020
US biopharma Unum Therapeutics has completed the acquisition of Kiq, a privately-held biotech focused on the discovery and development of precision kinase inhibitors. 6 July 2020
Cambridge, USA-based Dragonfly Therapeutics today announced a new research collaboration with Bristol-Myers Squibb to discover and develop Dragonfly's novel immunotherapies for multiple sclerosis and neuro-inflammation targets. 6 July 2020
Swiss oncology-focused drug discovery firm ADC Therapeutics today announced that the US Food and Drug Administration has lifted the partial clinical hold on the pivotal Phase II clinical trial of camidanlumab tesirine (Cami, formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma (HL). 6 July 2020
UK-based drug discovery and development company Mission Therapeutics, which is focused on selectively inhibiting deubiquitylating enzymes (DUBs), today announced that it has raised $15 million in equity investment. 6 July 2020
Swiss biotech Idorsia today announced positive top-line results of the second pivotal Phase III study investigating 10mg and 25mg doses of its dual orexin receptor antagonist, daridorexant, in 924 adult and elderly patients (39.3% ≥ 65 years) with insomnia. 6 July 2020
The specialist HIV company ViiV Healthcare, which is majority owned by GlaxoSmithKline, has announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. 3 July 2020
CSL Behring has announced that the European Medicines Agency (EMA) has approved the new Summary of Product Characteristics, which includes information about new, extended dosing options, for Idelvion (coagulation Factor IX [recombinant], albumin fusion protein; albutrepenonacog alfa). 3 July 2020
The US Phase III trial of rheumatoid arthritis drug Kevzara (sarilumab) in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo). 3 July 2020
The US Food and Drug Administration has approved a randomized, double-blind, placebo-controlled Phase III clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated acute respiratory distress syndrome (ARDS). 2 July 2020
Hopes for an effective vaccine against the novel coronavirus have been boosted by positive Phase I/II data from the BNT162 mRNA-based vaccine program. 2 July 2020
US clinical-stage immuno-oncology firm EpicentRx has entered into a licensing agreement for RRx-001, a small molecule immunotherapy targeting CD47 – SIRPα with ongoing Phase III trial in small cell lung cancer (SCLC), with China-owned SciClone Pharmaceuticals International. 1 July 2020