3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
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
Adding to its US regulatory clearance in August, the European Commission (EC) has now also granted conditional marketing authorization for Elrexfio (elranatamab), from US pharma giant Pfizer. 8 December 2023
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
Kedrion Biopharma has finalized an agreement with Germany-based Biotest for the long-term commercialization and distribution of Yimmugo (immune globulin) in the USA. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024
Privately-held Ferring Pharmaceuticals has announced the opening of a global manufacturing hub in Finland for the drug substance of its intravesical non-replicating gene therapy Adstiladrin (nadofaragene firadenovec-vncg). 3 October 2024
Shares of UK drug developer Hemogenyx Pharmaceuticals rose as much as 9% and closed up 5.9% at 1.70 pence yesterday on the news of a further investment from Prevail Partners. 3 October 2024
UK-based biotech Resolution Therapeutics has announced the completion of a £63.5 million ($76.8 million) series B financing round led by Syncona. 3 October 2024
The BioIndustry Association (BIA), in collaboration with the Centre for Process Innovation (CPI), has published a new report on the UK’s mRNA sector. 2 October 2024
Aspen Neuroscience, a private biotechnology company specializing in autologous cell therapies, has announced the opening of a major new facility near its headquarters in San Diego. 2 October 2024
Privately-held UK biotech Curve Therapeutics today announced the further strengthening of its leadership team with the appointments of Andre Hoekema as chairman of the board and Cora Griffin as head of business development. 2 October 2024
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Company Spotlight
A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.