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
GC Pharma, a South Korean biopharma formerly known as Green Cross Corporation, has set up a USA-based company dedicated to the development of new vaccines. 21 May 2018
Switzerland’s Roche and its majority-owned Japanese subsidiary Chugai Pharmaceutical have released full data from Phase III studies testing Hemlibra (emicizumab) as a treatment for haemophilia A. 21 May 2018
Newly-formed UTILITY therapeutics, which is focused on developing and commercializing antibiotics, has been granted Qualified Infectious Disease Products (QIDP) for both mecillinam and pivmecillinam, for the treatment of complicated urinary tract infections (cUTI). 21 May 2018
The US Food and Drug Administration is alerting health care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of two important immuno-oncology drugs. 21 May 2018
A long-term study has shown that NovoEight (turoctocog alfa) remains effective after three months of storage at a temperature of 40°c (104°f), according to findings presented on Monday at the World Federation of Hemophelia. 21 May 2018
GlaxoSmithKline has strengthened the data set supporting its anti-IL5 biologic treatment Nucala (mepolizumab) in severe eosinophilic asthma. 18 May 2018
Talking to investors in London, Takeda Pharmaceutical's chief executive Christophe Weber said his firm would remain focused on R&D to grow after his firm’s merger with rare disease specialist Shire. 18 May 2018
The first ever approval in a new and much-anticipated class of therapy, calcitonin gene-related peptide (CGRP) inhibitors, has been granted by the US Food and Drug Administration. 18 May 2018
Shares of US biotech Loxo Oncology leapt 21% to $167.53 after the firm released an abstract of early-stage data for its RET inhibitor LOXO-292. 18 May 2018
US ultra-rare diseases focussed biotech firm Ultragenyx Pharmaceutical and Japan’s Kyowa Hakko Kirin have announced that the Phase III study of Crysvita (burosumab) met its primary endpoint 17 May 2018
A record-breaking $260 million has been raised by CStone Pharmaceuticals, the largest series B financing round to have been completed by a Chinese biotech firm. 17 May 2018
The European Commission (EC) has approved a new indication in the Repatha (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels. 17 May 2018
Sensei Biotherapeutics, a privately-held company known as Panacea Pharmaceuticals until earlier this year, has announced the appointment of John Celebi as chief executive as the company seeks to push forward with its lead cancer vaccine. 16 May 2018
Genentech, the biotech unit of Swiss pharma giant Roche, has brought an end to its license and collaboration agreement with US immuno-oncology specialist NewLink Genetics. 16 May 2018
A pivotal Phase III trial evaluating Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents (aged 12-17) met its primary and key secondary endpoints. 16 May 2018
At a media event at Novo Nordisk headquarters in Copenhagen, the Danish diabetes giant provided insights into its clinical and commercial strategies on Wednesday.
While chief executive Lars Fruergaard Jørgensen said the firm was “more and more becoming a GLP-1 based company," chief scientific officer Mads Krogsgaard Thomsen said Novo was “maybe 8-10 years ahead of competition in oral GLP-1.” 16 May 2018
Danish diabetes care giant Novo Nordisk today announced an increased commitment to stem cell-based therapies and an expansion of the focus on type 1 diabetes into other serious chronic diseases. 16 May 2018
US pharma major Eli Lilly says that its drug candidate galcanezumab met its primary endpoint in a Phase III study of patients with episodic cluster headache, demonstrating statistically-significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period. 15 May 2018