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
Shares in contract manufacturing organization Samsung BioLogics (KRX: 207940) slumped almost a fifth this week after financial regulators said the biopharmaceutical firm was in violation of accounting rules. 3 May 2018
Privately-held USA-based biotech BeneVir has entered into a definitive agreement to be acquired by Janssen Biotech, part of US healthcare giant Johnson & Johnson. 2 May 2018
German life sciences major Merck KGaA today announced a development agreement for investigational molecule abituzumab with SFJ Pharmaceuticals Group (SFJ), a US-based company focused on increasing R&D output and productivity through innovative models. 2 May 2018
The US approval of Kymriah (tisagenlecleucel) last year enabled the Swiss pharma giant Novartis to boast that it had won the race to market with a CAR T-cell-directed therapy. 2 May 2018
The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending that Tremfya (guselkumab) be provided on the UK’s National Health Service (NHS) for patients with moderate to severe plaque psoriasis. 2 May 2018
New York’s Bristol-Myers Squibb is reportedly the latest drugmaker to step away from development of IDO blockers, a once promising field of immuno-oncology research that has hemorrhaged support since Incyte announced a bruising Phase III failure in this area last month. 2 May 2018
Diabetes care giant Novo Nordisk saw a near 6% bump in share price in Copenhagen this morning, after the world’s leading insulin provider released positive first-quarter financial results driven by rising diabetes rates worldwide. 2 May 2018
US biotech major Gilead Sciences late yesterday announced first-quarter 2018 financial results, posting total revenues of $5.09 billion, down 22% compared to $6.5 billion in 2017. 2 May 2018
Shares of US biotech major Biogen edged up 2% to $278.95 within an hour or so of the US biotech major announcing it had once again tweaked the terms of its deal with privately-held Swiss firm Neurimmune. 1 May 2018
Shares in New Jersey, USA-based Merck & Co are trading 1.5% lower ahead of the opening bell in New York, despite better-than-expected first quarter sales of $10 billion, up 6% from the same period last year. 1 May 2018
As part of a new European research project called Hypo-RESOLVE, a collection of more than 20 groups from academia, industry and civil society have joined forces to investigate solutions to alleviate the burden and consequences of hypoglycemia in diabetes. 1 May 2018
Shares in specialty Israeli pharma SteadyMed closed 77% up at $4.70 on Monday with the news that it is to be acquired by US drugmaker United Therapeutics. 1 May 2018
Opdivo (nivolumab) has been registered by Australia’s Therapeutic Goods Administration (TGA) as an adjuvant treatment for patients with completely resected melanoma with involvement of lymph nodes or metastatic disease. 1 May 2018
San Diego, USA-based synthetic biology specialist Synthorx has raised $63 million in a series C financing round led by OrbiMed, with money also from Medicxi, Osage University Partners, and other existing investors. 30 April 2018
The lead developer of drugs for cystic fibrosis (CF) is under pressure to slash the price of Orkambi (lumacaftor/ivacaftor), the first drug directed at treating the cause of the disease in people who have two copies of the F508del mutation, accounting for around 45% of cases. 30 April 2018
California biotech firm Rigel Pharmaceuticals today announced that the American Journal of Hematology has published positive results from the Fostamatinib in Thrombocytopenia (FIT) Phase III clinical program of Tavalisse (fostamatinib disodium hexahydrate) for the treatment of adults with chronic immune thrombocytopenia (ITP). 30 April 2018
Data from Phase II and Phase I studies was enough for the US Food and Drug Administration (FDA) to accept for priority review the Biologics License Application (BLA) for cemiplimab for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC patients who are not candidates for surgery. 30 April 2018
A newcomer on the biologics scene expressing a vision to become a global player is nothing new, but it is a bold ambition when coming from CinnaGen, an Iranian biosimilars company that is only just starting its journey in the world’s major pharma markets. 30 April 2018