Hematology Center of Sergipe

DUBLIN, Nov. 16, 2023 /PRNewswire/ -- The "Hematology Collaboration and Licensing Deals 2016-2023" report has been added to ResearchAndMarkets.com's offering. Hematology Collaboration and Licensing Deals provides a comprehensive understanding and unprecedented access to the hematology deals entered into by the worlds leading biopharma companies. This fully revised and updated report offers comprehensive details of hematology deals spanning from 2016 to 2023. It provides valuable insights into the terms of these deals as they were announced between the involved parties. This data is crucial for gaining a deeper understanding of the payment and other terms negotiated in these agreements. Understanding the flexibility and intricacies of the deal terms negotiated by potential partners offers essential insights into the negotiation process. It provides clarity on what can be expected during the negotiation of these terms. While many companies may focus on payment clauses, the critical details lie in understanding how payments are triggered and how rights are transferred. Contract documents provide this level of insight, which may not be readily available through press releases and databases. This report includes a comprehensive listing of collaboration and licensing deals announced since 2016, sourced from the Current Agreements deals and alliances database. It encompasses financial terms where available and includes links to online copies of actual licensing contract documents as submitted to the Securities Exchange Commission by the collaborating companies and their partners. Additionally, the report offers a comprehensive deal directory, organized alphabetically by company and technology type. Each deal title is linked via Weblink to an online version of the deal record and, where available, the contract document. This feature provides convenient access to each contract document as needed. Chapter Highlights The initial chapters of this report provide an orientation of hematology dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an analysis of the trends in hematology dealmaking. Chapter 3 covers the financial deal terms for deals signed in the hematology field with stage of development announced. Deals are listed and sectioned by headline value, upfront payment, milestone payment and royalty rates. Chapter 4 provides a review of the top 25 most active biopharma companies in hematology dealmaking. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances database. Chapter 5 provides a comprehensive and detailed review of hematology deals signed and announced since 2016 where a contract document is available. Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive directory of hematology deals listed by theraeutic target. The report also includes numerous table and figures that illustrate the trends and activities in hematology deal making since 2016. Hematology Collaboration and Licensing Deals provides the reader with the following key benefits: Understand deal trends since 2016 Browse hematology collaboration and licensing deals Benchmark analysis - identify market value of transactions Financials terms - upfront, milestone, royalties Directory of deals by company A-Z, therapy focus and technology type Leading deals by value Most active dealmakers Identify assets and deal terms for each transaction Access contract documents - insights into deal structures Due diligence - assess suitability of your proposed deal terms for partner companies Save hundreds of hours of research time Hematology Collaboration and Licensing Deals includes: Trends in hematology dealmaking in the biopharma industry Overview of collaboration and licensing deal structure Directory of hematology deal records covering pharmaceutical and biotechnology The leading hematology deals by value Most active hematology licensing dealmakers Analyzing contract agreements allows due diligence of: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in hematology dealmaking 2.1. Introduction 2.2. Hematology partnering over the years 2.3. Hematology partnering by deal type 2.4. Hematology partnering by industry sector 2.5. Hematology partnering by stage of development 2.6. Hematology partnering by technology type 2.7. Hematology partnering by therapeutic indication Chapter 3 - Financial deal terms for hematology partnering 3.1. Introduction 3.2. Disclosed financials terms for hematology partnering 3.3. Hematology partnering headline values 3.4. Hematology deal upfront payments 3.5. Hematology deal milestone payments 3.6. Hematology royalty rates Chapter 4 - Leading hematology deals and dealmakers 4.1. Introduction 4.2. Most active in hematology partnering 4.3. List of most active dealmakers in hematology 4.4. Top hematology deals by value Chapter 5 - Hematology contract document directory 5.1. Introduction 5.2. Hematology partnering deals where contract document available Chapter 6 - Hematology dealmaking by therapeutic target 6.1. Introduction 6.2. Deals by hematology therapeutic target Deal Directory Deal directory - Hematology deals by company A-Z 2016 to 2023 Deal directory - Hematology deals by technology type 2016 to 2023 For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Approval by the European Commission would expand the indications of Reblozyl for treatment of anemia in adults with beta thalassemia in Europe In the pivotal BEYOND study, Reblozyl significantly increased hemoglobin levels, which were sustained over longer time compared to placebo PRINCETON N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of Reblozyl® (luspatercept) as a treatment for adult patients with anemia associated with non‑transfusion-dependent (NTD) beta thalassemia. The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union (EU). Upon approval, this would represent the third authorized indication for Reblozyl in the EU. The CHMP adopted a positive opinion based on results from the pivotal Phase 2 BEYOND study, evaluating the efficacy and safety of Reblozyl versus placebo in 145 adults with NTD beta thalassemia. Patients were eligible to receive best supportive care, including red blood cell transfusions, iron-chelating agents, use of antibiotic, antiviral, and antifungal therapy, and/or nutritional support, as needed. Reblozyl is an erythroid maturation agent approved in the EU, the United States, China and Canada to address anemia-associated, transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes, representing an important class of therapy for eligible patients. “Beta thalassemia is an inherited blood disorder that puts patients at significant risk for long-term clinical complications that can impair their quality of life, regardless of whether they require regular blood transfusions,” said Noah Berkowitz, ​M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. “Results from the BEYOND study showed Reblozyl improved anemia associated with non-transfusion-dependent beta thalassemia by sustaining hemoglobin increases in 77% of patients regardless of their baseline hemoglobin status. The potential approval of Reblozyl for patients with non-transfusion-dependent beta thalassemia represents an important development in the EU where several countries present with a high prevalence and where more people are impacted by the disease.” The EC is expected to deliver its final decision within 67 days of receipt of the CHMP opinion. The decision will be applicable to all EU member states, Iceland, Norway and Liechtenstein.* Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. *Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales). About BEYOND BEYOND (NCT03342404) is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in adults with non-transfusion-dependent beta thalassemia. The study is divided into the Screening Period, Double-blind Treatment Period (DBTP), Open-label Phase (OLP), and Post-Treatment Follow-up Period (PTFP) and randomized 145 subjects at a 2:1 ratio of Reblozyl versus placebo. All patients were eligible to receive best supportive care, which included red blood cell transfusions; iron-chelating agents; use of antibiotic, antiviral, and antifungal therapy; and/or nutritional support, as needed. The primary endpoint of the study is the proportion of subjects who have an increase from baseline ≥1.0 g/dL in mean of hemoglobin values over a continuous 12-week interval from Week 13 to Week 24 of treatment in the absence of transfusions. Key secondary endpoints include mean change in non-transfusion-dependent beta thalassemia-patient reported outcome (NTDT-PRO) Tiredness and Weakness (TW) domain score and baseline hemoglobin (Hb). Results demonstrated 74 of 96 (77.1%) patients in the Reblozyl treatment arm achieved the study’s primary endpoint, ≥1.0 g/dL mean Hb increase from baseline, versus 0 of 49 (0%) patients in the placebo arm (P<0.0001). In a key secondary endpoint of the study, 47 of 96 patients (49.0%) treated with Reblozyl achieved mean Hb increase of ≥1.5 g/dL compared to baseline from Week 37-48 in the absence of transfusions versus 0 patients (0%) in the placebo arm. In the Reblozyl arm, 89.6% of patients remained transfusion free at weeks 1-24 versus 67.3% of patients in the placebo arm. Improvements in patient reported quality of life outcomes (tiredness and weakness) were also observed to correlate with Hb increases. Serious adverse reactions occurred in 11.5% of patients (n=11) who received Reblozyl and in 25% of patients (n=24) who received placebo. The most common adverse reactions occurring in ≥10% of patients treated with Reblozyl were bone pain (36%), headache (30%), arthralgia (29%), back pain (28%), prehypertension (23%), hypertension (20%), cough (18%), diarrhea (17%), influenza-like illness (17%), asthenia (13%), influenza (13%), insomnia (11%) and nausea (10%). About Beta Thalassemia Beta thalassemia is an inherited blood disorder caused by a genetic defect in hemoglobin. It is one of the most common autosomal recessive disorders, and the total annual incidence of symptomatic individuals is estimated at 1 in 100,000 people globally.1,2 The disease is associated with ineffective erythropoiesis, which results in the production of fewer and less healthy red blood cells, often leading to severe anemia—a condition that can be debilitating and can lead to other complications for patients—as well as other serious health issues such as iron overload.3 Treatment options for anemia associated with beta thalassemia are limited, consisting mainly of frequent red blood cell transfusions and iron chelation therapy, and have the potential to contribute to iron overload, which can cause serious complications such as organ damage.1 Non-transfusion-dependent beta thalassemia is a term used to describe patients who do not require lifelong regular transfusions for survival, though they may experience a range of significant clinical complications and require intermittent or more frequent transfusions for defined periods of time.4 About Reblozyl® Reblozyl, a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models.1 Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. Reblozyl is currently approved in the U.S. for the treatment of: anemia in adult patients with beta thalassemia who require regular red blood cell transfusions, and anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Important Safety Information WARNINGS AND PRECAUTIONS Thrombosis/Thromboembolism In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly. Hypertension Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 1.8% to 8.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In adult patients with MDS with normal baseline blood pressure, 26 (29.9%) patients developed SBP ≥130 mm Hg and 23 (16.4%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents. Extramedullary Hematopoietic Masses In adult patients with transfusion-dependent beta thalassemia, EMH masses were observed in 3.2% of REBLOZYL-treated patients, with spinal cord compression symptoms due to EMH masses occurring in 1.9% of patients (BELIEVE and REBLOZYL long-term follow-up study). In a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of EMH masses was observed in 6.3% of REBLOZYL-treated patients vs. 2% of placebo-treated patients in the double- blind phase of the study, with spinal cord compression due to EMH masses occurring in 1 patient with a prior history of EMH. REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia. Possible risk factors for the development of EMH masses in patients with beta thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines. Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses. Embryo-Fetal Toxicity REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose. ADVERSE REACTIONS Beta Thalassemia Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML). Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%). Myelodysplastic Syndromes Grade >3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients. The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection. LACTATION It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose. Please see full Prescribing Information and Summary of Product Characteristics for REBLOZYL. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming people’s lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the CHMP opinion is not binding on the EC, that Reblozyl® (luspatercept) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidate for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news References: Galanello R, Origa R. Beta thalassemia. Orphanet Journal of Rare Diseases. 2010;5(11). Available at: . Accessed February 2022. Iolascon, A., et al. (2019, June). EHA research roadmap on hemoglobinopathies and thalassemia: Hemasphere. . Accessed November 2022. Rivella, S. (2013). Ineffective erythropoiesis and thalassemias. Available at: . Accessed February 2022. Musallam, K. M., Rivella, S., Vichinsky, E., & Rachmilewitz, E. A. (2013). Non-transfusion-dependent thalassemias. Haematologica, 98(6), 833–844. . Accessed February 2022.

DUBLIN--( BUSINESS WIRE )--The "2022 What's Next for World Hematology and Flow Cytometry Analyzer and Reagent Markets" report has been added to ResearchAndMarkets.com's offering. This survey from the publisher provides granular data and analysis not available elsewhere. The survey is designed to help current suppliers and potential market entrants identify and evaluate emerging opportunities emerging in the global hematology and flow cytometry markets during the next five years. Rationale Continued advances in molecular diagnostics, monoclonal antibodies, lasers and IT, as well as growing understanding of immunologic forces regulating systemic diseases, will have a profound impact on the hematology and flow cytometry markets worldwide. New molecular diagnostic and monoclonal antibody tests will facilitate existing procedures and provide basis for sensitive, specific and simple assays. The introduction of smaller and easy-to-operate laser systems will further expand applications of flow cytometry to routine clinical laboratories. Further advances in IT will reduce the cost of instrument manufacture, service warranty, and permit development of self-troubleshooting, auto-calibration and other advanced features. Presently tedious analyses of chromosomal abnormalities, DNA content, and lymphocyte subsets will become more automated and routine. Geographic Regions and Countries Asia-Pacific Australia, Bangladesh, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, New Zealand, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand, Turkey, Vietnam Europe Albania, Austria, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Kazakhstan, Latvia, Lithuania, Malta, Moldova, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK, Ukraine Latin America Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Haiti, Honduras, Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, Puerto Rico, Uruguay, Venezuela Middle East Bahrain, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, United Arab Emirates North America Canada, Mexico, USA Strategic Recommendations New product development opportunities with significant market appeal. Alternative market penetration strategies. Potential market entry barriers and risks. Market Segmentation Analysis Sales and market share estimates of leading hematology and flow cytometry product suppliers in major countries. Specimen, test and sales forecasts for over 40 procedures. Sales and Market Share Analysis Sales and market shares of major instrument and reagent suppliers in major countries. Hematology Tests Analyzed in the Report CBC + 5-Part Differential, Manual Differential/Review, Hematocrit (Automated, Manual), Hemoglobin (Automated, Manual), Sedimentation Rate, Reticulocytes, WBC (Automated, Manual), Platelets (Automated, Manual), Bone Marrow Analysis, RBC, Eosinophils Flow Cytometry Tests Analyzed in the Report Cell Surface Markers (CD4/CD8/T&B Lymphocytes, CD34, Others), Chemotherapy Monitoring (Leukemia/Lymphoma, Others), HLA Typing, Sperm Analysis, Cell Cycle Kinetics, Cell Function Testing, Chromosomal Abnormalities, Fetal Cell Analysis, Granulocyte Function, Receptor DNA/RNA Analysis, Cell Culturing Instrumentation Review Reviews of current instrumentation technologies, and features of leading hematology, flow cytometry, platelet aggregation and sedimentation rate analyzers. The report features analyzers marketed by Abbott, Beckman Coulter/Danaher, Becton Dickinson, Biocode Hycel, CellaVision, Diesse Ves Matic, Drew-Scientific, Horiba, Medica, Menarini, Nihon Kohden, Polymedco, Siemens, Sysmex and other suppliers. Technology Review Assessment of current and emerging technologies and their potential market applications. Companies developing or marketing new technologies and products by test. Competitive Assessments Strategic profiles of major suppliers and emerging market entrants. The companies analyzed in the report include: Abbott Agilent Technologies Beckman Coulter/Danaher Becton Dickinson Bio-Rad CellaVision Horiba Nihon Kohden Ortho-Clinical Diagnostics Roche Siemens Healthineers Sysmex For more information about this report visit https://www.researchandmarkets.com/r/5a9wwl