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 European Commission (EC) has granted conditional marketing authorization for gene therapy Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene). 4 June 2019
Germany’s Ethris, a leader in mRNA-based therapeutics, is expanding its leadership team by the addition of Thomas Langenickel in the role of chief medical officer. 4 June 2019
Bristol-Myers Squibb has announced updated results from studies evaluating Opdivo (nivolumab) and Yervoy (ipilimumab) at the annual meeting of the American Society of Clinical Oncology (ASCO). 4 June 2019
Deciding which company has presented the most significant data at an ASCO meeting is often a matter of perspective, but Amgen is definitely a contender at this year's event. 3 June 2019
Merck & Co’s industry-leading immuno-oncology drug Keytruda (pembrolizumab) is no stranger to making the headlines at ASCO, and this year’s meeting is no exception. 3 June 2019
Much awaited Phase III POLO trial data were presented at the 2019 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, and showed that Lynparza (olaparib) has a significant impact of progression of disease in certain pancreatic cancer patients. 3 June 2019
Positive data at the annual meeting of the American Society of Clinical Oncology (ASCO) will help boost chances for Sanofi’s isatuximab in a looming head-to-head with Johnson & Johnson’s Darzalex (daratumumab). 3 June 2019
Immunotherapy specialist Atara Biotherapeutics has presented clinical results relating to its biomarker research at the annual meeting of the American Society of Clinical Oncology (ASCO). 3 June 2019
New baseline biomarker analyses and updated clinical study efficacy and safety results were shared in a presentation, titled "Baseline tumor-immune signatures associated with response to bempegaldesleukin (NKTR-214, bempeg), at the 2019 American Society of Clinical Oncology (ASCO) meeting in Chicago. 3 June 2019
Shares of Humanigen rose 8.7% to $1.24 by mid-morning today, after it revealed a clinical collaboration with Gilead Sciences’ subsidiary Kite to trial a combination of its flagship therapy in combination with one of the first CAR-T cell therapy to be approved by the US regulator. 31 May 2019
Japanese drug major Astellas Pharma today announced that the US Food and Drug Administration approved a supplemental New Drug Application (sNDA) to update the US product labeling for Xospata (gilteritinib) to include final analysis data from the ADMIRAL trial. 31 May 2019
Vertex Pharmaceuticals says it has selected the triple combination of the next-generation corrector VX-445 (elexacaftor), tezacaftor and ivacaftor to submit for potential global regulatory approvals for people ages 12 and older with cystic fibrosis (CF). 31 May 2019
Atara Biotherapeutics, a US biotech specializing in T-cell immunotherapies for cancer, has named Pascal Touchon its new president, chief executive. 30 May 2019
Inovio Pharmaceuticals regained much of the losses it suffered in the stock market on Wednesday, but the company’s share price was heading south again on Thursday. 30 May 2019
California clinical-stage biotech Inhibrx has entered into an agreement with privately held Italian drugmaker Chiesi Farmaceutici, granting the latter an option to exclusively license, develop and commercialize INBRX-101 outside of the USA and Canada effective upon a $10 million equity investment in Inhibrx. 30 May 2019
The National Institute for Health and Care Excellence (NICE) has published its Final Appraisal Document for the use of Merck & Co’s Prevymis (letermovir/ID1153) in preventing cytomegalovirus (CMV) reactivation and disease in patients receiving an allogeneic stem cell transplant. 30 May 2019
The share price of Canadian biopharma Zymeworks (TSX: ZYME) closed 4% up on Wednesday after the company received two separate validations of its approach. 30 May 2019
USA-based private equity firm Ampersand Capital Partners announced plans to acquire Vibalogics GmbH, a German contract development and manufacturing organization (CDMO) focused on complex live biological products. 30 May 2019
German pharma major Boehringer Ingelheim and Danish biotech Gubra has announced a second collaboration and license agreement for the development of new poly-agonist peptides to treat obesity. 29 May 2019
Biomunex Pharmaceuticals, a privately-held French biotech focused on providing immuno-therapeutics through the discovery and development of bi- and multi-specific antibodies, has established a US subsidiary. 29 May 2019