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
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorization at its December 2016 meeting. 17 December 2016
Rather like Kite’s registrational Zuma-1 trial of KTE-C19 in lymphoma, Novartis’ Eliana study has generated a fileable response rate. In the case of the Swiss firm’s rival CAR-T therapy, CTL019, this is in childhood leukemia patients, says EP Vantage, the editorial arm of the Evaluate group. 10 December 2016
Breakthrough immunotherapy Opdivo (nivolumab) has been approved in the European Union for the treatment of classical Hodgkin lymphoma (cHL), a rare and often-aggressive blood cancer. 7 December 2016
Janssen Research and Development, a subsidiary of the US health care giant Johnson & Johnson, has presented Phase II data on Imbruvica (ibrutinib) in chronic graft-versus-host-disease (cGVHD), who failed prior systemic therapy. 6 December 2016
Swiss pharma giant Novartis has responded to the growing competition to its off-patent product Gleevec (imatinib mesylate) by presenting the latest findings on its new drug that it wants patients to start taking as a replacement therapy. 6 December 2016
New data from the Phase III GALLIUM study has been presented at the 58th American Society of Hematology (ASH) annual meeting which suggests that Gazyvaro (obinutuzumab) could be an effective first-line treatment for follicular lymphoma (FL). 5 December 2016
Data presented at the 58th American Society of Hematology (ASH) Annual Meeting has offered hope that the first new sickle cell-related pain crises (SCPC) option for 20 years could be on its way. 5 December 2016
US biotech Celgene, the Dana-Farber Cancer Institute and the University of Arkansas for Medical Sciences have announced the creation of the Myeloma Genome Project. 5 December 2016
Denmark’s Novo Nordisk has announced new results on NovoSeven (rFVIIa), a portable room temperature stable recombinant activated factor VIIa, at the 58th American Society of Hematology (ASH) annual meeting. 5 December 2016
In another reversal of a negative cancer drug opinion from the cost-effectiveness watchdog for England and Wales based on the drug manufacturer’s agreement on a price discount, the agency has said that a new drug for the treatment of leukemia can be used routinely on the National Health Service. 25 November 2016
The European Commission has granted conditional marketing authorization for Ninlaro (ixazomib) capsules, indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy. 24 November 2016
UK biotech Kymab has taken a major step forward in advancing its proprietary pipeline of first-in-class therapeutic human monoclonal antibodies. 24 November 2016
Shares of US biotech firm Juno Therapeutics plunged as much as 44%, before recovering to $21.56 for a 27,8% slide by late morning New York trading, after it announced another setback for its leukemia drug candidate. 23 November 2016
Swiss pharma giant Novartis, which has recently been rumored to be on the acquisition trail for AstraZeneca (LSE: AZN) - which rejected a $69 billion bid from Pfizer in 2014, today announced something far less ambitious with the takeover of a small US pharma company. 21 November 2016
Israel’s Teva Pharmaceutical Industries (NYSE TEVA) today announced it has obtained approval from the European Commission for an indication extension for its leukemia drug. 21 November 2016
Spanish drugmaker Grifols raised 1 billion euros ($1.06 billion) in revenue in the third quarter of 2016, a 3% increase compared with the same period the previous year. 18 November 2016
More than 75% of treatments in the UK’s Cancer Drugs Fund (CDF) which have been reappraised by the National Institute for Health and Care Excellence (NICE) have received positive recommendations for routine use in the NHS. 17 November 2016
US biotech major Biogen has named two members to the executive management team of Bioverativ, its planned spin-off company focused on the discovery, research, development and commercialization of treatments for hemophilia and other blood disorders. 16 November 2016
The myelofibrosis market is expected to almost double in value from $545.2 million in 2015 to $1.02 billion by 2025, representing a compound annual growth rate (CAGR) of 6.4%, a new study reveals. 16 November 2016
uniQure says it has completed a company-wide strategic review aimed at refocusing its pipeline, consolidating its manufacturing and enhancing overall execution to drive shareholder value. 15 November 2016