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
New York, USA-based biotech Regeneron has reported a positive third quarter revenue result, with sales up 23% to $2.05 billion, compared with the same period last year. 5 November 2019
US biotech firm Halozyme Therapeutics today announced that the HALO-301 Phase III clinical study evaluating its investigational new drug PEGPH20 as a first-line therapy for treatment of patients with metastatic pancreas cancer failed to reach the primary endpoint of overall survival. 4 November 2019
US therapeutic gene editing company Sangamo Therapeutics has appointed Sung Lee as executive vice president and chief financial officer, effective October 31, 2019. Mr Lee oversees finance, facilities and information technology functions for Sangamo and reports to the firm’s chief executive. 2 November 2019
USA-based biotech Ovid Therapeutics has made two senior leadership changes to further build the company’s capabilities as it approaches top-line results from the pivotal Phase III NEPTUNE trial for OV101 in Angelman syndrome, expected in mid-2020. 2 November 2019
Having closed Wednesday regular trading down marginally on Thursday, China’s BeiGene shot up 22.9% to $170.00 in after-trading as it announced a strategic collaboration with US biotech giant Amgen. 1 November 2019
US biotech firm Dicerna Pharmaceuticals yesterday announced a research collaboration and licensing agreement with Swiss pharma giant Roche to develop novel therapies for the treatment of chronic hepatitis B virus (HBV) infection using Dicerna’s proprietary GalXC RNAi platform technology. 1 November 2019
Third-quarter 2019 sales for US biotech Celgene came in at $4.52 billion, up 16% year-on-year and beating consensus forecasts of $4.41 billion. 1 November 2019
Genmab, one of the world’s most notable biotech success stories of recent years, has announced that one of those who helped to drive its rapid growth is to retire. 1 November 2019
European Medicines Agency’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of Lemtrada (alemtuzumab) in patients with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage. 31 October 2019
US drugmaker AbbVie is eyeing a second approval for its JAK inhibitor Rinvoq (upadacitinib), just 11 weeks after announcing its first one. 31 October 2019
Japanese drug major Sumitomo Dainippon Pharma and Roivant Sciences, a technology-enabled healthcare company, today announced that they have signed a definitive agreement for the creation of a novel and broad Strategic Alliance and to form a new company (the “New Company”) owned and supported by Sumitomo Dainippon. 31 October 2019
Privately-held US biotech Pandion Therapeutics and Japanese drugmaker Astellas have announced a collaboration with a potential value of $795 million. 31 October 2019
German life sciences group Bayer was up more than 2% as Wednesday’s trading day neared its end, after the company presented its third-quarter financial results. 30 October 2019
The US Food and Drug Administration approved Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. 30 October 2019
Germany’s MorphoSys and Belgium’s Galapagos today announced the end of the clinical development program of MOR106 in atopic dermatitis. 30 October 2019
The European Medicines Agency has validated the Marketing Authorization Application (MAA) for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it accelerated assessment. 30 October 2019
The US Food and Drug Administration (FDA) has placed a partial hold on spinal muscular atrophy (SMA) clinical trials for the intrathecal administration of a gene therapy that is already approved as an intravenous treatment. 30 October 2019
US biotech giant Amgen posted third-quarter 2019 financials after market close on Tuesday that beat expectations, but the stock dipped in after-hours trading, having ended the regular trading session up 1.94% to $208.99. 30 October 2019