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
Bristol Myers Squibb’s closed up 1.6% at $65.46 on Friday, after the US pharma major bagged another indication for its blockbuster immuno-oncology drug Opdivo (nivolumab), and this came well ahead of the prescription drug user fee act (PDUFA) goal date for a decision on the immunotherapy regimen of May 25. 17 April 2021
The US Food and Drug Administration on Friday revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. 17 April 2021
US health technology assessor the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of UK drugmaker GlaxoSmithKline’s Benlysta (belimumab) and Canadian firm Aurinia’s Lupkynis (voclosporin) for the treatment of lupus nephritis (LN). 16 April 2021
Roche today announced new Ocrevus (ocrelizumab) analyses supporting its significant benefit on disease progression in early-stage relapsing-remitting multiple sclerosis (RRMS) and primary progressive MS (PPMS) as well as demonstrating high persistence and strong adherence to twice-yearly (six-monthly) dosing. 16 April 2021
A licensing deal between XOMA Corporation and Affimed Therapeutics is starting to bear fruit, with progress in three innate cell engager (ICE) programs. 16 April 2021
The European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody. 16 April 2021
The approval of a Food and Drug Administration (FDA) emergency use authorization (EUA) for AstraZeneca’s COVID-19 vaccine AZD1222, now dubbed Vaxzevria, will boost confidence and use of the vaccine globally. 16 April 2021
For biotech companies, the prospect of receiving non-dilutive, non-recourse funding to advance their assets even through the early stages of clinical development may sound too good to be true. 16 April 2021
California, USA-based biotech BioAge Labs has entered into an exclusive worldwide license agreement with Amgen to develop and commercialize Amgen’s clinical-stage APJ agonist, BGE-105 previously (named AMG 986 by Amgen) to ameliorate muscle aging. 15 April 2021
Cambridge, UK-based biotech Alchemab Therapeutics today announced the completion of a £60 million ($82 million) Series A financing round. 15 April 2021
The National Institute for Care and Health Excellence’s (NICE) has recommended Ultomiris (ravulizumab) for use in the National Health Service (NHS) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 15 April 2021
UK endocrine diseases specialist Diurnal Group has withdrawn its application for maintenance of orphan designation in Europe for Efmody (hydrocortisone modified-release hard capsules), a drug formerly known as Chronocort. 15 April 2021
US pharma giant Merck & Co today announced it will discontinue the development of MK-7110 (formerly known as CD24Fc) for the treatment of hospitalized patients with COVID-19. 15 April 2021
PTC Therapeutics has announced new data showing continued improvements in motor milestones in infants with type 1 spinal muscular atrophy (SMA) after two years of treatment with Evrysdi (risdiplam). 15 April 2021
UK pharma major GlaxoSmithKline today announced that, following a recommendation by the Independent Data Monitoring Committee, it has taken the decision to stop enrolling patients in the Phase II INDUCE-3 trial, including discontinuing treatment with feladilimab. 15 April 2021
China’s SciNeuro Pharmaceuticals has entered into an exclusive license agreement with US pharma major Eli Lilly for the development and commercialization of alpha-synuclein targeted antibody therapies in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. 15 April 2021
Pfizer and BioNTech’s Comirnaty (tozinameran) is forecast to have peak sales of $24.8 billion by 2021, which is only its second year on the market. 15 April 2021