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
At the 65th American Society of Hematology (ASH) annual meeting, Gilead Sciences company Kite announced results from a three-year follow-up analysis of the ZUMA-12 trial. 12 December 2023
Australian biotech CSL Limited has announced the three-year results from the pivotal HOPE-B study confirming continued long-term durability and safety of Hemgenix (etranacogene dezaparvovec-drlb) following a one-time infusion in people living with hemophilia B. 12 December 2023
Adding to the string of companies seeking to expand into the attractive antibody-drug conjugates (ADCs) space, Bristol Myers Squibb has announced an exclusive license and collaboration agreement for US clinical-stage biotech SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific ADC. 12 December 2023
Spanish dermatology specialist Almirall and etherna, a privately-held Belgian mRNA/lipid nanoparticle (LNP) technology platform company, have announced a collaboration. 12 December 2023
The US Food and Drug Administration (FDA) has accepted Pfizer’s Biologics License Application (BLA) for its anti-tissue factor pathway inhibitor (anti-TFPI) candidate marstacimab for individuals living with hemophilia A or hemophilia B without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). 12 December 2023
The US Federal Trade Commission (FTC) is seeking to block French pharma major Sanofi’s proposed acquisition of an exclusive license to Maze Therapeutics therapy in development for treatment of Pompe disease. 12 December 2023
Shares of USA-based Skye Bioscience rose 14% to $3.99 by mid-morning, after it revealed its intent to enter the huge and fast-growing obesity treatment sector. 11 December 2023
Cell therapy company AbelZeta Pharma has announced an agreement with AstraZeneca to co-develop a new CAR T-cell therapy in hepatocellular carcinoma (HCC). 11 December 2023
The European Commission (EC) has granted marketing authorization of a new indication Jemperli (dostarlimab), from UK pharma major GSK. 11 December 2023
The Johnson & Johnson subsidiary Janssen has presented new long-term follow-up data at the 2023 American Society of Hematology (ASH) Annual Meeting from the Phase III GLOW and Phase II CAPTIVATE studies of first-line, fixed-duration treatment with Imbruvica (ibrutinib) plus AbbVie’s enclexta (venetoclax). 11 December 2023
Swiss pharma giant Roche has presented new data from its CD20xCD3 T-cell engaging bispecific antibody program at the 65th American Society of Hematology (ASH) Annual Meeting. 11 December 2023
Adding Sarclisa (isatuximab) to carfilzomib, lenalidomide and dexamethasone (KRd) caused a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly-diagnosed multiple myeloma (MM). 11 December 2023
The US Food and Drug Administration (FDA) on Friday approved two milestone treatments, Casgevy (exagamglogene autotemcel [exa-cel]), and Lyfgenia (lovotibeglogene autotemcel [lovo-cel)], representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD). 11 December 2023
Singapore-based clinical-stage biotech Hummingbird Bioscience today announced the appointment of Angèle Maki, as chief business officer (CBO), with immediate effect. 11 December 2023
US pharma major Bristol Myers Squibb has presented updated results from the primary analysis of the Phase III COMMANDS trial at the 2023 American Society of Hematology (ASH) Annual Meeting. 10 December 2023
Findings from the pivotal Phase III BASIS clinical trial evaluating marstacimab for the treatment of people with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) were released at the American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego. 10 December 2023
At this year’s American Society of Hematology (ASH) Annual Meeting, Swiss pharma giant Roche announced that the primary analysis of the Phase III HAVEN 7 study reinforced the efficacy and safety of Hemlibra (emicizumab) in previously untreated or minimally treated infants with severe hemophilia A without factor VIII inhibitors. 10 December 2023
Shares of Intensity Therapeutics skyrocketed 120% to $8.79 pre-market today, after it announced positive safety, tolerability, efficacy and immune activation data from the company’s Phase II INVINCIBLE trial of INT230-6 in patients with early-stage breast cancer. 9 December 2023
With the end of the year approaching, it is again time for The American Society of Hematology (ASH) Annual Meeting, the last major pharmaceutical conference in the calendar. 9 December 2023