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
Beating estimates for revenues and profits, Californian biotech Amgen presented strong results for the final quarter and full year of 2023 on Wednesday. 7 February 2024
The UK's Medicines and Healthcare Regulatory Agency (MHRA) has licensed subcutaneous (SC) injectable Vyvgart (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. 7 February 2024
The long and winding road of biopharma development has taken another turn for Rallybio, with the firm opting to slash almost half of its workforce to preserve cash. 7 February 2024
Ireland-headquartered Jazz Pharmaceuticals and UK biotech Redx Pharma today announced a definitive agreement under which Jazz will acquire Redx's KRAS (Kirsten rat sarcoma virus) inhibitor program. 7 February 2024
US biotech major Gilead Sciences announced results of operations for the fourth quarter and full year 2023 after markets closed yesterday that were generally in line with Wall Street expectations. 7 February 2024
Augmenting its strategic push into cell therapies, British pharma major AstraZeneca has announced that it will construct a state-of-the-art facility in Maryland, USA. 7 February 2024
US healthcare giant Johnson & Johnson late Monday announced top-line results from the pivotal Phase III VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG), as well as the Phase II DAHLIAS study of nipocalimab in adults with Sjögren’s disease (SjD). 6 February 2024
Another encouraging result in the growth area of antibody-drug conjugates (ADC) reveals a significant survival benefit for people with multiple myeloma. 6 February 2024
In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics’ made history by gaining the first FDA approval for a CRISPR-based drug, Casgevy (exagamglogene autotemcel) for the treatment of sickle cell disease with vaso-occlusive crisis. 6 February 2024
Swiss pharma giant Novartis late yesterday announced that it has entered into an agreement to make a voluntary public takeover offer to acquire MorphoSys, a Germany-based biopharmaceutical company developing innovative medicines in oncology. 6 February 2024
US genetic medicines company 4D Molecular Therapeutics was trading more than 70% higher during Monday morning's opening exchanges in New York. 5 February 2024
Neuropsychologist Dr Paul Wicks joins the ranks of Cambridge, UK-based precision medicine scaleup Sano Genetics today, where he will take up the full-time role of vice president of neuroscience. 5 February 2024
Phase III trial data results of the R21/Matrix-M vaccine developed by Oxford University and Serum Institute of India (SII), leveraging Novavax’ Matrix-M adjuvant has confirmed high efficacy and supported regulatory approvals and licensure in several African countries. 5 February 2024
Ahead of World Cancer Day, this is a great time to reflect on the advances in oncology which are providing hope and momentum in the global fight against cancer, says Dr Michael Ybarra, chief medical officer at trade group Pharmaceutical Research and Manufacturers of America (PhRMA). 5 February 2024