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
Some $230 million has now been raised by Ring Therapeutics, a life sciences company founded by Flagship Pioneering with the aim of revolutionizing gene therapy with its commensal virome platform. 10 March 2023
New clinical data from US pharma giant Merck & Co for MK-0616, an investigational oral cholesterol-lowering drug, revealed that it significantly reduced low-density lipoprotein (LDL) cholesterol in adults. 10 March 2023
The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC). 10 March 2023
Effective March 11, Gustavo Pesquin will become the next chief executive (CEO) of Asklepios BioPharmaceutical (AskBio), which was acquired in 2020 by Germany’s Bayer. 9 March 2023
Shares of MacroGenics were up 10.9% at $6.10 in early trading today, after the biopharmaceutical company revealed that it has entered into an agreement to sell its royalty interest on future global net sales of Tzield (teplizumab-mzwv) to a wholly-owned subsidiary of DRI Healthcare Trust for up to $200 million. 9 March 2023
Staff at the US Food and Drug Administration (FDA) have prepared a report on the use of Roche’s Polivy (polatuzumab vedotin) alongside Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated large B-cell lymphoma. 9 March 2023
Latest trail results show that solanezumab did not slow the progression of cognitive decline due to Alzheimer's disease (AD) pathology when initiated in individuals with amyloid plaque but no clinical symptoms of the disease, known as the pre-clinical stage of admitted US pharma major Eli Lilly. 9 March 2023
The US subsidiary of Japanese drug major Astellas Pharma today announced disappointing top-line results from the Phase III MORPHO clinical trial evaluating gilteritinib as a maintenance therapy following allogeneic hematopoietic stem cell transplantation (HSCT) for patients with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutated acute myeloid leukemia (AML). 9 March 2023
Cambridge, USA-based clinical-stage biotech QurAlis Corporation has closed an oversubscribed $88 million Series B financing, bringing the total funds raised by the company0 to $143.5 million. 9 March 2023
Biotech companies in the Asia-Pacific (APAC) region are trailing Western rivals in terms of venture capital financing, according to a report from GlobalData. 9 March 2023
UK pharma major AstraZeneca this morning released new Phase III data on two of its oncology drugs, showing positive results in lung cancer survival. 9 March 2023
UK biotech Redx Pharma added to its woes, announcing that top-line results of its Phase II program were not sufficient enough to support the development of its RXC004 treatment as a monotherapy. 8 March 2023
Italian drugmaker Chiesi and Swedish biotech Affibody have agreed a collaboration and licensing agreement to develop and commercialize innovative treatments for respiratory diseases using the latter company’s technology. 8 March 2023
The strategic venture capital unit of US healthcare giant Johnson & Johnson (NYSE: JNJ) has put its weight behind a $100 million boost for a new precision medicine company. 8 March 2023
Protagonist Therapeutics’ shares closed up a massive 52% at $23.09 yesterday, after it announced positive top-line results from the FRONTIER 1 Phase IIb clinical trial evaluating the oral Interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in patients with moderate-to-severe plaque psoriasis. 8 March 2023
Japanese biotech Carna Biosciences has terminated a licensing deal with its Chinese partner BioNova Pharmaceuticals and regained all China rights of the asset AS1763, a BTK inhibitor treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and B-cell non-Hodgkin lymphoma (B-cell NHL). 8 March 2023
An analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed that Enhertu (trastuzumab deruxtecan) met the prespecified target for objective response rate (ORR) and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pre-treated patients. 7 March 2023
US clinical-stage cancer biotech Volastra Therapeutics, which is focused on exploiting chromosomal instability (CIN), today announced completion of the in-licensing of Amgen’s sovilnesib (AMG650), an oral, first-in-class small molecule inhibitor of KIF18A. 7 March 2023