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
Swiss drugmaker Santhera Pharmaceuticals has had its marketing authorization application (MAA) accepted for Puldysa (idebenone) to treat respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) who are not using glucocorticoids. 25 June 2019
UK-based C4X Discovery Holdings saw its shares climb 4.55% to 52.80 pence, after announcing a collaboration with PhoreMost, a UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets. 25 June 2019
Europe's biggest privately-held biotech BioNTech has been in the news recently, with reports the company could be about to raise just shy of a billion dollars in a US listing. 25 June 2019
The US Food and Drug Administration has issued a priority review voucher (PRV) to rare disease specialist AveXis, part of Swiss pharma giant Novartis. 25 June 2019
USA-based antibacterial products developer Entasis Therapeutics has announced the appointment of David Meek, currently chief executive of French pharma company Ipsen, as chairman of the board of directors, effective immediately. 25 June 2019
Positive Phase II results on the first topical gene therapy sent a US biotech company’s share price up by 27% in Monday morning’s trading. 24 June 2019
The US Food and Drug Administration has lifted the partial clinical hold placed on CANOVA (M13-494) in March this year, a Phase III trial evaluating venetoclax (trade named Venclexta and Venclyxto) for the investigational treatment of relapsed/refractory multiple myeloma. 24 June 2019
Bristol-Myers Squibb has announced that, to help proceed its $74 billion acquisition of biotech major Celgene, it would sell one of the latter’s top-selling drugs, Otezla (apremilast). 24 June 2019
New Jersey, USA-based drugmaker Bristol-Myers Squibb has announced a Phase III trial miss for Opdivo (nivolumab), with topline data showing the study did not meet its primary endpoint of overall survival (OS). 24 June 2019
In a filing with the US Securities and Exchange Commission (SEC), US biotech Exelixis has said it was informed last week by its collaboration partner Genentech, a US subsidiary of the Swiss pharma giant Roche, that the IMspire170 had failed to achieve pre-set goals. 24 June 2019
Some eight months after gaining marketing clearance for the drug in the USA, and an April advisory committee recommendation in Europe, US pharma giant Pfizer has now also won approval for Talzenna (talazoparib) in the European Union. 24 June 2019
The healthcare industry is at an inflection point with the market now preparing for more cell and gene therapies to be approved, writes Ana Stojanovska, vice president of Commercial Consulting at Xcenda, in an Expert View piece. 21 June 2019
For Belgium-based drugmaker UCB, EULAR 2019 came at a good time to shed further new light on bimekizumab – which the company itself is billing as its pipeline molecule – in a couple of the indications in which it is showing significant promise. 21 June 2019
The US cost-effectiveness group Institute for Clinical and Economic Review (ICER) yesterday released a Final Evidence Report assessing the comparative clinical effectiveness and value of Swiss pharma giant Novartis’ Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS). 21 June 2019
A Phase II proof-of-concept trial evaluating the investigational interleukin (IL)-33 antibody REGN3500 (SAR440340) met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. 21 June 2019
At its first investor day in five years, New Jersey, USA-based Merck & Co (NYSE: MRK) outlined key aspects of its clinical and commercial strategy, with chief executive Kenneth Frazier describing: “tremendous growth opportunities beyond Keytruda.” 21 June 2019
Danish diabetes care giant Novo Nordisk announced late yesterday d that the European Commission has granted marketing authorization for Esperoct (turoctocog alfa pegol, N8-GP) for the treatment of adolescents (≥12 years of age) and adults with hemophilia A. 21 June 2019
US gene therapy company Axovant Sciences has signed a strategic partnership with Yposkesi, a French contract development and manufacturing organization (CDMO). 20 June 2019
US protein engineering company Codexis says that Casdin Capital, a New York City-based life science-focused investment firm and current stockholder of Codexis, has invested around $50 million in Codexis through the purchase of shares of Codexis’ common stock in a private placement. 20 June 2019