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Pharmaceutical
The combined use of two well-known active substances can fight leukemic cells and limit their spread. This is the result of a study conducted by the Karl Landsteiner University of Health Sciences (KL Krems) and recently published in the journal Cancer Letters. 5 March 2025
Pharmaceutical
US clinical-stage pharma company Protagonist Therapeutics and Japan’s Takeda have announced positive top-line results for the Phase III VERIFY study, in which phlebotomy-dependent patients with polycythemia vera (PV), a rare blood cancer, were randomized to treatment with either rusfertide or placebo, as an add-on to standard of care treatment. 4 March 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its February 2025 meeting. The European Commission is expected to announce a final decision on approval in the coming months. 1 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. 26 February 2025
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Sarclisa (isatuximab), in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the IMROZ Phase III study. 25 February 2025
Biotechnology
US pharma giant Pfizer has ended all development and commercialization activities relating to fidanacogene elaparvovec, a hemophilia B gene therapy marketed as Beqvez in the USA and Durveqtix in Europe. 24 February 2025
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending the use Breyanzi (lisocabtagene maraleucel) for National Health Service (NHS) in England. 21 February 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Altuvoct (efanesoctocog alfa) to be used to treat and prevent bleeding in patients aged two years and above with severe or moderate hemophilia A. 18 February 2025
Pharmaceutical
USA-based Agios Pharmaceuticals has announced that the ACTIVATE-Kids Phase III study of mitapivat in children aged 1 to <18 years with pyruvate kinase (PK) deficiency who are not regularly transfused achieved its primary endpoint of hemoglobin response. 14 February 2025
Pharmaceutical
Antengene has announced that its multiple myeloma treatment, Xpovio (selinexor), will be included in Taiwan’s National Health Insurance (NHI) reimbursement scheme. 13 February 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin) in yet another indication, US pharma giant Pfizer announced late yesterday. 13 February 2025
Biotechnology
IN8bio has announced encouraging new clinical data from its ongoing Phase I trial of INB-100, an allogeneic gamma-delta T cell therapy being tested in patients with acute myeloid leukemia (AML). 12 February 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the Phase II TRANSCEND FL trial evaluating Breyanzi (lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary endpoint in the marginal zone lymphoma (MZL) cohort. 11 February 2025
Biotechnology
Marking World Cancer Day 2025, this week's Executive Q&A is with Diego Santoro, General Manager & Head of International Region at Gilead and Kite Oncology. Mr Santoro outlines the company’s efforts to expand access to innovative CAR T-cell therapies in the Middle East. 8 February 2025
Biotechnology
Biotech firm CSL Behring has announced the four-year results from the pivotal HOPE-B study confirming the long-term durability and safety of a one-time infusion of Hemgenix (etranacogene dezaparvovec) for adults living with hemophilia B. 7 February 2025
Pharmaceutical
Danish pharma major Novo Nordisk has announced interim results from the Phase III FRONTIER3 trial of 70 children with hemophilia A with and without inhibitors. 7 February 2025
Biosimilars
Dr Reddy’s Laboratories has signed a licensing deal with Shanghai Henlius Biotech to develop and commercialize HLX15, a biosimilar of Johnson & Johnson’s Darzalex (daratumumab) for multiple myeloma. 7 February 2025
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca beat analyst expectations in presenting its impressive latest financial results. 6 February 2025
Biotechnology
Eleva, a German biopharmaceutical company, and 3PBIOVIAN, a global contract development and manufacturing organization (CDMO), have announced a strategic partnership to enhance the production of Eleva's pipeline products. 4 February 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines for approval at its January 2025 meeting, as well as some biosimilars. 31 January 2025
Pharmaceutical
The combined use of two well-known active substances can fight leukemic cells and limit their spread. This is the result of a study conducted by the Karl Landsteiner University of Health Sciences (KL Krems) and recently published in the journal Cancer Letters. 5 March 2025
Pharmaceutical
US clinical-stage pharma company Protagonist Therapeutics and Japan’s Takeda have announced positive top-line results for the Phase III VERIFY study, in which phlebotomy-dependent patients with polycythemia vera (PV), a rare blood cancer, were randomized to treatment with either rusfertide or placebo, as an add-on to standard of care treatment. 4 March 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its February 2025 meeting. The European Commission is expected to announce a final decision on approval in the coming months. 1 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. 26 February 2025
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Sarclisa (isatuximab), in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the IMROZ Phase III study. 25 February 2025
Biotechnology
US pharma giant Pfizer has ended all development and commercialization activities relating to fidanacogene elaparvovec, a hemophilia B gene therapy marketed as Beqvez in the USA and Durveqtix in Europe. 24 February 2025
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending the use Breyanzi (lisocabtagene maraleucel) for National Health Service (NHS) in England. 21 February 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Altuvoct (efanesoctocog alfa) to be used to treat and prevent bleeding in patients aged two years and above with severe or moderate hemophilia A. 18 February 2025
Pharmaceutical
USA-based Agios Pharmaceuticals has announced that the ACTIVATE-Kids Phase III study of mitapivat in children aged 1 to <18 years with pyruvate kinase (PK) deficiency who are not regularly transfused achieved its primary endpoint of hemoglobin response. 14 February 2025
Pharmaceutical
Antengene has announced that its multiple myeloma treatment, Xpovio (selinexor), will be included in Taiwan’s National Health Insurance (NHI) reimbursement scheme. 13 February 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin) in yet another indication, US pharma giant Pfizer announced late yesterday. 13 February 2025
Biotechnology
IN8bio has announced encouraging new clinical data from its ongoing Phase I trial of INB-100, an allogeneic gamma-delta T cell therapy being tested in patients with acute myeloid leukemia (AML). 12 February 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the Phase II TRANSCEND FL trial evaluating Breyanzi (lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary endpoint in the marginal zone lymphoma (MZL) cohort. 11 February 2025
Biotechnology
Marking World Cancer Day 2025, this week's Executive Q&A is with Diego Santoro, General Manager & Head of International Region at Gilead and Kite Oncology. Mr Santoro outlines the company’s efforts to expand access to innovative CAR T-cell therapies in the Middle East. 8 February 2025
Biotechnology
Biotech firm CSL Behring has announced the four-year results from the pivotal HOPE-B study confirming the long-term durability and safety of a one-time infusion of Hemgenix (etranacogene dezaparvovec) for adults living with hemophilia B. 7 February 2025
Pharmaceutical
Danish pharma major Novo Nordisk has announced interim results from the Phase III FRONTIER3 trial of 70 children with hemophilia A with and without inhibitors. 7 February 2025
Biosimilars
Dr Reddy’s Laboratories has signed a licensing deal with Shanghai Henlius Biotech to develop and commercialize HLX15, a biosimilar of Johnson & Johnson’s Darzalex (daratumumab) for multiple myeloma. 7 February 2025
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca beat analyst expectations in presenting its impressive latest financial results. 6 February 2025
Biotechnology
Eleva, a German biopharmaceutical company, and 3PBIOVIAN, a global contract development and manufacturing organization (CDMO), have announced a strategic partnership to enhance the production of Eleva's pipeline products. 4 February 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines for approval at its January 2025 meeting, as well as some biosimilars. 31 January 2025
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