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
Boston, USA-based non-profit the Institute for Clinical and Economic Review (ICER) has published a report on barriers to fair access in the US insurance industry. 3 November 2023
Independent French drugmaker Pierre Fabre has expanded a global partnership for Ebvallo (tabelecleucel) with US biotech Atara Biotherapeutics. 3 November 2023
San Diego, USA-based biotech AnaptysBio’s ground breaking Phase III trial results for imsidolimab, a novel inhibitor, bring renewed hope to patients battling generalized pustular psoriasis (GPP). 3 November 2023
San Diego, USA-based precision medicine firm Kura Oncology’s shares rose 4% to $8.31 yesterday, after it announced a research collaboration with Mirati Therapeutics. 3 November 2023
Eli Lilly has reported strong revenues for the third quarter, with blockbuster diabetes med Mounjaro (tirzepatide) doing much of the heavy lifting. 2 November 2023
US mRNA specialist Moderna today reported financial results for the third quarter of 2023 that disappointed, sending its shares down 8.9% to $69.23 in early trading. 2 November 2023
Regeneron Pharmaceuticals today announced financial results for the third quarter of 2023, showing that total revenues for the quarter came in at $3,363 million, rise of 15%, and beating consensus forecasts by 5%. 2 November 2023
The Crohn's disease (CD) treatment arena is set for a notable transformation, with novel therapies expected to drive significant market growth. 2 November 2023
The European Medicines Agency (EMA) has validated the submission for Braftovi (encorafenib) with Mektovi (binimetinib), submitted by privately-held French drugmaker Pierre Fabre, for the treatment of adult patients with BRAFV600-mutant advanced non-small cell lung cancer (NSCLC). 2 November 2023
Indian contract development and manufacturing organization (CDMO) Aragen is to build a new biologics manufacturing facility in Bangalore. 2 November 2023
The US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Committee concluded that Vertex Pharmaceutical and Swiss gene editing specialist CRISPR Therapeutics’ exagamglogene autotemcel (exa-cel) is generally safe for clinical use. 1 November 2023
Merck & Co has secured another approval from the US Food and Drug Administration for its blockbuster immuno-oncology product, Keytruda (pembrolizumab). 1 November 2023
French biotech Cellectis saw its shares rocket 149% to 2.24 euros by mid-afternoon trading today, on news of a collaboration an investment deal with UK pharm major AstraZeneca. 1 November 2023
Adding to recent regulatory approvals in the USA and European Union, pharma giant Pfizer can now add the UK to the geographies where its alopecia treatment can be marketed. 1 November 2023
On Tuesday, US biotech company Novavax, which is advancing protein-based vaccines with its Matrix-M adjuvant, announced a timely update with its Nuvaxovid XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted). 1 November 2023
US biotech giant Amgen saw its shares fall by 4.4% to $251.44 on Tuesday, after it announced financial results for the third quarter of 2023. 1 November 2023
Swiss pharma major Novartis has secured another approval from the US regulator for Cosentyx (secukinumab), a biologic which blocks the IL-17A cytokine. 1 November 2023
UK clinical-stage biotech STORM Therapeutics, which is targeting RNA modifying enzymes (RMEs) for oncology and other diseases, has appointed Marguerite Hutchinson as its chief business officer. 1 November 2023