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Mashup Score: 12
Recommendation based on results from CheckMate -901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate a survival benefit versus standard-of-care chemotherapy alone in cisplatin-eligible adults with unresectable or metastatic urothelial carcinoma If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU A decision on the EU marketing authorization is expected by June 2024 Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The final EC
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 29
Bristol Myers Squibb will utilize Cellares’ proprietary Cell Shuttle, a next-generation end-to-end, fully automated cell therapy manufacturing platform, for the clinical and commercial-scale manufacturing of select CAR T cell therapies Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO), will allocate multiple Cell Shuttles and its fully automated, high-throughput Cell Q systems across its IDMO Smart Factories in the U.S., EU and Japan for Bristol Myers Squibb’s use This agreement strengthens Bristol Myers Squibb’s existing global network of state-of-the-art cell therapy manufacturing facilities and provides increased agility, improved scalability and potential to improve turnaround time to support the company’s CAR T inline and pipeline assets Bristol Myers Squibb (NYSE: BMY) and Cellares , the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, today announced a
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 23
Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program Bristol Myers Squibb (NYSE: BMY) today announced data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating KRAZATI ® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRAS G12C -mutated locally advanced or metastatic colorectal cancer (CRC). These late breaking data (abstract #CT013) will be featured in an oral presentation at the 2024 American Association for Cancer Research (AACR) annual meeting on Monday, April 8 at 11:10 a.m. Pacific Time and will be highlighted as part of the meeting’s official press program. The data will also be published simultaneously in Cancer Discovery . With a median follow up of 11.9 months in 94 patients, KRAZATI plus cetuximab demonstrated an objective response rate, the primary endpoint, of
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 4
Several blood thinners are being developed that could prevent the clots that cause heart attacks and strokes—without some of the side effects.
Source: www.wsj.comCategories: General Medicine News, PayerTweet
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Mashup Score: 16
KarXT demonstrated a favorable long-term metabolic profile where most patients experienced stability or improvements on metabolic parameters over 52 weeks of treatment A majority of patients (65%) experienced reductions in weight over the course of the trial, with a mean weight decrease of 2.6kg observed at one year Data show no significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores over 52 weeks KarXT was generally well tolerated, with a side effect profile consistent with prior trials of KarXT in schizophrenia Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia. These data were presented in a poster titled, “Long-Term Safety of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F74) and in the Oral Session “Long-Term Metabolic Outcomes Associated With KarXT
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 16
Long-term treatment with KarXT was associated with continued improvements in symptoms of schizophrenia across all efficacy measures at 52 weeks More than 75% of participants achieved >30% improvement in symptoms from baseline, as measured by the Positive and Negative Syndrome Scale (PANSS) total score, at one year Participants previously on placebo in acute trials experienced significant reduction of symptoms beginning at week two and maintained throughout treatment Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia. Long-term efficacy data from the trial were presented in a poster titled, “Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F264) at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 20
Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death and a well-established safety profile Expanded approval brings this personalized CAR T cell therapy to more patients with relapsed or refractory multiple myeloma earlier in their treatment journey as a one-time infusion offering meaningful treatment-free intervals when responding to therapy Abecma is now approved in the U.S., Japan, Switzerland and the EU for earlier use for triple-class exposed relapsed and/or refractory multiple myeloma, underscoring BMS’ commitment to delivering Abecma globally, with consistently high manufacturing success rates and continuous increases in capacity Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 20
Approval of Reblozyl is based on head-to-head, pivotal Phase 3 COMMANDS study, in which Reblozyl nearly doubled the percentage of patients achieving transfusion independence and hemoglobin increase, along with increased durability compared to epoetin alfa This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia and the first therapy to demonstrate superior efficacy vs. epoetin alfa in LR-MDS Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has expanded approval of Reblozyl® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). This approval of Reblozyl covers all EU member states.* “With this approval for Reblozyl as a first-line treatment for anemia in adults with lower-risk MDS, more patients in the EU will have the potential to become transfusion
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 6Bristol Myers Squibb Releases 2023 Environmental, Social and Governance Report Demonstrating Progress and Setting New Long-Term Goals - 1 month(s) ago
Company builds on its strengths to advance patient access, product innovation, culture and inclusion and diversity Bristol Myers Squibb (NYSE: BMY) today published its 2023 Environmental, Social, and Governance (ESG) Report detailing the company’s meaningful progress, evolved strategy, and aspirational goals toward its ESG efforts. The company’s ESG strategy is embedded in its mission to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. “For more than 130 years, BMS has enabled positive change for our patients around the world. As we navigate an increasingly complex global landscape, our ESG strategy has never been more important to driving long-term business value and fulfilling our purpose,” said Christopher Boerner , Ph.D., Board Chair Chief Executive Officer, Bristol Myers Squibb. “We recognize ESG is a journey of continuous improvement, and our entire team is committed to advancing sustainability.” In 2023, BMS conducted a
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Mashup Score: 32
Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer Bristol Myers Squibb (NYSE: BMY) today announced that the pivotal Phase 3 KRYSTAL-12 study, evaluating KRAZATI® (adagrasib) as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation, met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR) as assessed by Blinded Independent Central Review (BICR) at final analysis for these endpoints. The study remains ongoing to assess the additional key secondary endpoint of overall survival. Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to
Source: news.bms.comCategories: General Medicine News, PayerTweet
#MEDIA: The @EMA_News #CHMP issued a positive opinion for our #immunotherapy-chemotherapy combination as a first-line treatment for adult patients with unresectable or metastatic #urothelialcarcinoma. https://t.co/AQrjrsoi4z https://t.co/c4A3j8twAi