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
AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). 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
CSL Behring has been granted a positive recommendation by the Spanish Interministerial Commission on the Pricing of Medicines (CIPM), resulting in national reimbursement for Hemgenix (etranacogene dezaparvovec) for eligible haemophilia B patients in Spain. 1 October 2024
Johnson & Johnson has announced long-term results from the Phase III CARTITUDE-4 study showing that a single infusion of Carvykti (ciltacabtagene autoleucel; cilta-cel) significantly extended overall survival (OS) in those with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI). 30 September 2024
Pfizer (NYSE: PFE) has announced the withdrawal of Oxbryta (voxelotor), a treatment for sickle cell disease (SCD), from all global markets. 26 September 2024
US biotech 2seventy bio and partner Bristol Myers Squibb today revealed that they will discontinue enrollment in its ongoing Phase III KarMMa-9 study. 25 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
Aptadir Therapeutics, a biotech company focused on RNA inhibitor-based therapies for cancer and genetic conditions, has launched with $1.6 million in pre-seed funding. 24 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
The upcoming European Society for Medical Oncology (ESMO) Congress 2024 should provide a reminder—if it were needed—of the pace of innovation in the development of new medicines for cancer. 10 September 2024
Epsilogen, a specialist in the development of immunoglobulin E (IgE) antibodies to treat cancer, has announced the completion of a £12.5 million ($16.4 million) Series B expansion financing. 9 September 2024
Vor Bio has announced positive data from its ongoing Phase I/II VBP101 study evaluating the combination of trem-cel and Mylotarg (gemtuzumab ozogamicin) in people with relapsed or refractory acute myeloid leukemia (AML). 9 September 2024
Last week’s research news included French pharma major Sanofi releasing mixed Phase III results for it tolebrutinib in progressive multiple sclerosis. Also of note, US vaccine developer Vaxcyte announced strong early-stage trial results for its VAX-31 in pneumococcal disease. On the regulatory front, US drugmaker Travere Therapeutics gained full approval from the US Food and Drug Administration (FDA) for its kidney disease drug Filspari. US cancer drug developer IN8bio announced a prioritization of its R&D pipeline to focus on INB-100 in acute myeloid leukemia, along with a workforce cutback. 8 September 2024
Shares of US gamma-delta T cell therapies for cancer developer IN8bio closed down more than 7% yesterday and fell a further 3.2% to $0.465 pre-market, after it announced a major reshuffle. 5 September 2024
American critical care specialist Citius Pharma is to list its oncology subsidiary on the Nasdaq exchange, via merger with a special purpose acquisition company (SPAC). 25 October 2023
Shanghai-based gene therapy company Belief BioMed (BBM) has out-licensed certain rights for the commercialization of its hemophilia candidate, BBM-H901. 23 October 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today authorized a new medicine called, Tepkinly (epcoritamab), as a treatment for diffuse large B-cell lymphoma (a type of blood cancer) in adults. 20 October 2023
Nearly five months have passed since the Annual Meeting of the American Society of Clinical Oncology (ASCO) took place, and cancer-focused drugmakers are ready once again to dump their data to the world’s oncologists, media and more. 19 October 2023
Swiss pharma giant Roche saw its shares fall more than 5% to 254.60 francs this morning, after it posted a cautious forecast for full-year 2023. 19 October 2023
China’s CARsgen Therapeutics has announced the publication of two cases of long-term disease-free survival in the treatment of advanced hepatocellular carcinoma (HCC) with its CAR-GPC3 T-cell therapy. 12 October 2023
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today announced that Lydia Abad-Franch has been appointed as senior vice president, head of research, development and medical affairs (RDMA), and chief medical office, a role which she has held on an interim basis since June. 5 October 2023
Despite positive top-line data, Syndax Pharmaceuticals stock has fallen more than a tenth, following an interim analysis from the AUGMENT-101 trial. 3 October 2023
US pharma major AbbVie (NYSE: ABBV) saw its shares dip 2.1% to $149.06 on Friday after it announced disappointing data from its Phase III CANOVA study evaluating the safety and efficacy of Venclexta (venetoclax). 2 October 2023
Moving the compound a step closer to regulatory approval, the US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) filed by US biotech Regeneron Pharmaceuticals for odronextamab. 29 September 2023
Gilead Sciences has released a statement confirming it has stopped its ENHANCE-2 study of magrolimab in acute myeloid leukemia (AML). 27 September 2023
The US Food and Drug Administration has granted a new approval for US pharma giant Pfizer’s hematologic malignancies drug Bosulif (bosutinib). 27 September 2023
The European Commission (EC) has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. 25 September 2023
Having gained US and Taiwan regulatory approval for its hematology drug Altuviiio (efanesoctocog alfa) earlier this year, French pharma major Sanofi has now bagged marketing clearance in Japan. 25 September 2023
Regulatory news last week included the US Food and Drug Administration a(FDA) approving UK pharma major GSK’s new myelofibrosis drug Ojjaara (momelotinib) with a wider indication than what hade been expected. The US Federal Commission (FTC) issued a policy on the listing of patents in the FDA’S Orange Book. Last Tuesday, Chinese biotech BeiGene revealed that Swiss pharma giant Novartis has pulled out of a second collaboration, this time regarding time regarding Tevimbra (tislelizumab). Also of note on the research front, US CNS specialist Relmada Therapeutics released positive Phase III results for its REL-1017 as a treatment for major depressive disorder (MDD). 24 September 2023