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 US Food and Drug Administration has granted Breakthrough Therapy designation for JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in previously-treated patients with multiple myeloma. 9 December 2019
US biotech Cassava Sciences, previously known as Pain Therapeutics, was up 41% premarket on Friday on increased volume in reaction to new data from a Phase IIa clinical trial evaluating lead drug, PTI-125, in patients with mild-to-moderate Alzheimer's disease (AD). 9 December 2019
Texas, USA-based XBiotech revealed on Saturday that it has entered into a definitive agreement with Janssen Biotech, part of US healthcare giant Johnson & Johnson, to sell its novel antibody, bermekimab, that neutralizes interleukin-1 alpha (IL-1⍺). IL-1⍺ promotes disease-causing inflammation in a wide range of medical conditions. 7 December 2019
Sales of the multiple myeloma drug Darzalex (daratumumab) have hit $2.5 billion in a calendar year, which is good news not just for Janssen, the exclusive global license holder. 5 December 2019
US immune-oncology drug developer RAPT Therapeutics and South Korea’s Hanmi Pharmaceutical have entered into a license and collaboration agreement for FLX475 in Asia, worth up to $118 million 5 December 2019
The Australian biotech industry has voiced consternation at the government’s decision to move forward with a plan to cut R&D incentives in the country. 5 December 2019
Idoesia has granted Japan’s Mochida Pharmaceutical an exclusive license for the supply, co-development and co-marketing of daridorexant, Idorsia’s dual orexin receptor antagonist (DORA), for insomnia and related disorders in Japan. 5 December 2019
Privately-held US biotech Tetra Therapeutics has presented data showing that TNF-blocking agents reduce the risk of Alzheimer’s disease in patients with rheumatoid arthritis or psoriasis. 5 December 2019
US biotech firm Axsome Therapeutics yesterday announced that its AXS-12 (reboxetine) met the prespecified primary endpoint and significantly reduced the number of cataplexy attacks as compared to placebo in patients with narcolepsy in the CONCERT Phase II trial. 4 December 2019
USA-based Puma Biotechnology and privately-held French drugmaker Pierre Fabre have agreed to extend the terms of the license agreement in which Puma granted Pierre Fabre exclusive rights to develop and commercialize Nerlynx (neratinib) within Europe and part of Africa. 4 December 2019
The US Food and Drug Administration has approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. 4 December 2019
French biotech ImCheck Therapeutics has raised $53 million in a Series B financing to advance its clinical pipeline of gamma delta T-cell-focused antibodies for cancer and autoimmune diseases. 4 December 2019
Australian plasma and cell and gene therapy specialist CSL Limited is steadily advancing its R&D pipeline and capabilities to deliver a highly differentiated product portfolio mix, addressing a broader range of patients’ unmet needs,” said head of Research & Development Dr William Mezzanotte today. 4 December 2019
French drugmaker Sanofi is presenting clinical data from its insulin portfolio at the 2019 congress of the International Diabetes Federation, in Busan, South Korea. 4 December 2019
Privately-held UK biotech Mission Therapeutic and US major AbbVie today announced the identification of several deubiquitylating enzymes (DUBs) as potential drug targets in their Alzheimer’s and Parkinson’s R&D collaboration. 3 December 2019
India's Biocon, Asia's premier biotechnology company, has named Siddharth Mittal as its new chief executive and joint managing director. 3 December 2019
Astellas Pharma on Monday evening announced that it has entered into a definitive agreement to acquire US biotech Audentes Therapeutics at a price of $60.00 per share in cash. 3 December 2019
Texan biopharma Lexicon Pharmaceuticals lost more than 10% of its marke
t value on Monday as the company suffered a new setback in the development of Zynquista (sotagliflozin). 3 December 2019
French healthcare non-profit Médecins Sans Frontières (MSF) has called on Gavi, the Vaccine Alliance, to stop payments to pharma majors Pfizer and GlaxoSmithKline for their pneumococcal vaccine. 3 December 2019
Japan’s Astellas Pharma and USA-based Seattle Genetics have entered into a clinical collaboration agreement with pharma giant Merck & Co to evaluate the combination of their antibody-drug conjugate (ADC) enfortumab vedotin and Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with previously untreated metastatic urothelial (mostly bladder) cancer. 2 December 2019