Viz.ai Wins 2024 Edison Award™ for Innovation for Second Year in a Row

Viz.ai Wins 2024 Edison Award™ for Innovation for Second Year in a Row




Viz.ai Wins 2024 Edison Award™ for Innovation for Second Year in a Row

Honored for excellence in innovation in cardiovascular & ophthalmic innovations

SAN FRANCISCO–(BUSINESS WIRE)–#ai–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced that it has been named an Edison Award Winner in the 2024 Edison Awards, for the second year in a row. Viz PE with right ventricle/left ventricle ratio (RV/LV), the company’s AI software solution designed to detect and triage pulmonary embolism (PE) and right heart strain, was recognized in the Cardiovascular & Ophthalmic Innovations category. The prestigious Edison Awards, named after the American inventor Thomas Alva Edison, honor excellence in new product and service development, marketing, design and innovation.




“We are honored to win our second Edison Award for innovation,” said Dr. Chris Mansi, CEO and co-founder of Viz.ai. “When we started Viz.ai, we had a vision that by using artificial intelligence, we could help healthcare systems work smarter and faster, improving patient outcomes and ultimately saving lives. Every year in the United States, pulmonary embolism affects around 900,000 patients.1 The recognition of Viz PE, which has the potential to deliver faster and optimal care for patients with pulmonary embolism, validates our efforts to make this vision a reality.”

Viz PE with automated RV/LV ratio measurement became an FDA-cleared AI-powered solution for the detection of suspected PE and assessment of right heart strain in 2022, in partnership with Avicenna.AI. PE is a serious condition, with untreated acute cases having a mortality rate as high as 30% within one month of diagnosis. Timely detection and triage by a multidisciplinary Pulmonary Embolism Response Team (PERT) are critical for patients. Recent data shows that the Viz PE solution combined with PERT activation significantly improved time to assessment and time to anticoagulation with a 74% reduction in in-hospital mortality risk.2

All nominations are reviewed by the Edison Awards’ Steering Committee and an executive judging body. The panel is composed of more than 2,000 senior business executives and academics from the fields of product development, design, engineering, science, marketing and education, as well as past winners.

Winners were announced at the Edison Awards Gala on April 18, 2024 in Fort Myers, FL.

For more information on Viz PE, please visit https://www.viz.ai/pulmonary-embolism.

1 Association, A. L. (n.d.). Learn about pulmonary embolism. American Lung Association. https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism

2 Shapiro J. Shorter Time to Assessment and Anticoagulation with Decreased Mortality in Patients with Pulmonary Embolism Following Implementation of Artificial Intelligence Software. Presented at: AVF, March 2024.

About Viz.ai

Viz.ai is the pioneer in the use of AI algorithms and machine learning to increase the speed of diagnosis and care across 1,600+ hospitals and health systems in the U.S. and Europe. The AI-powered Viz.ai OneTM is an intelligent care coordination solution that identifies more patients with a suspected disease, informs critical decisions at the point of care, and optimizes care pathways and helps improve outcomes. Backed by real-world clinical evidence, Viz.ai One delivers significant value to patients, providers, and pharmaceutical and medical device companies. For more information visit viz.ai.

About The Edison Awards

Established in 1987, the Edison Awards are dedicated to recognizing, honoring and fostering innovations and innovators. Named after Thomas Alva Edison (1847-1931), the annual competition honors excellence in new product and service development, marketing, human-centered design and innovation. Past award recipients include Jony Ive, Martha Stewart, Carmichael Roberts and companies leading in innovation including; Nest, now part of Google, AMD, Intel, Naqi, 3M and Cargill. In 2021, the Edison Awards introduced the inaugural Lewis Latimer Fellowship program designed to celebrate, connect and bring together a community of innovative Black thought leaders. For more information, visit www.edisonawards.com.

Contacts

Olivia Schlabach

olivia.schlabach@finnpartners.com

Targeted Sequencing Industry Report 2024: A $3.479 Billion Market in a Growth Phase with Illumina Dominating – Global Analysis and Forecasts 2023-2033 – ResearchAndMarkets.com

Targeted Sequencing Industry Report 2024: A $3.479 Billion Market in a Growth Phase with Illumina Dominating – Global Analysis and Forecasts 2023-2033 – ResearchAndMarkets.com




Targeted Sequencing Industry Report 2024: A $3.479 Billion Market in a Growth Phase with Illumina Dominating – Global Analysis and Forecasts 2023-2033 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Targeted Sequencing Market – A Global and Regional Analysis: Focus on Application, Product Type, Target Enrichment Methods, Type of Target Capture, End User, and Region – Analysis and Forecast, 2024-2033” report has been added to ResearchAndMarkets.com’s offering.


In 2023, the targeted sequencing market held a value of $3,479.8 million. The market is expected to grow at a CAGR of 12.28% during the forecast period 2024-2033 and attain a value of $10,987.4 million by 2033, driven by increasing research initiatives, rising demand for precision medicine, and geographical expansion of key players.

The global targeted sequencing market has been characterized by intense competition, as established entities and emerging players compete for a share of the market. The anticipated growth and transformation of the market bring forth both challenges and opportunities, which are expected to make it a dynamic landscape to observe in the upcoming years.

The targeted sequencing market in the North America region has been witnessing significant growth of 12.39% in the forecast period, marked by increasing research and development in the region and early adoption of advanced technologies. In 2023, North America accounted for a share of 49.90% of the global targeted sequencing market.

Industry Impact

Targeted sequencing is expected to be a period of wider adoption in clinical settings across various applications. For instance, use in early disease detection, personalized treatment selection, and monitoring treatment response. Additionally, continuous price reduction and higher throughput are driving the widespread adoption at the patient level. Increasing focus on automation in targeted sequencing workflows, single-cell sequencing, advancements in bioinformatics, liquid handling, and nucleic acid preparation are expected to continue to transform targeted sequencing methods. The industry is likely to witness the dynamic contributions of genomics and precision diagnostics.

The industry’s advancements in targeted sequencing research and development continually address population health trends, disease prevalence, and treatment outcomes. As a result, the targeted sequencing market’s impact extends beyond technological integration for diagnosis, making it an integral component of global health strategies and broader ecosystem.

Cancer to Dominate the Global Targeted Sequencing Market (by Application)

The cancer segment dominated the global targeted sequencing market (by application) in FY2023.

Targeted sequencing panels are rapidly becoming the standard of care in the management of patients with advanced cancer. NGS-based gene panel tests have successfully identified driver mutations in colorectal cancer, breast cancer, and lung cancers, which has subsequently resulted in the development and use of targeted therapies associated with improved outcomes.

Academic and Research Institutions to Dominate the Global Targeted Sequencing Market (by End User)

The academic and research institutions segment dominated the global targeted sequencing market (by end user) in FY2023.

Growing research initiatives undertaken by universities and research institutes in exploring new applications for targeted sequencing are driving the academic and research institutions segment growth.

Services to Dominate the Global Targeted Sequencing Market (by Product Type)

The global targeted sequencing market (by product type) was dominated by the services segment in FY2023. This is largely due to the value proposition offered by targeted sequencing services. These services present an economically viable, efficient, and expertise-centric approach for laboratories and researchers.

Hybridization Capture to Dominate the Global Targeted Sequencing Market (by Target Enrichment Method)

The global targeted sequencing market (by target enrichment method) was dominated by the hybridization capture segment in FY2023. The hybridization capture-based method is more suitable for research and discovery projects. Therefore, scientists and clinicians tend to employ hybridization capture for large panels for the detection of SNPs, fusion genes, copy number variations (CNV), and others.

Targeted DNA Sequencing to Dominate the Global Targeted Sequencing Market (by Target Capture)

The global targeted sequencing market (by target capture) was dominated by the targeted DNA sequencing segment in FY2023. Targeted DNA sequencing allows researchers to focus time and expense on the data analysis of only the regions of interest.

Key Market Players and Competition Synopsis

The global targeted sequencing industry is in a growth phase and constantly evolving. Illumina, Inc. holds a significant market share in terms of technology and consumables and is expected to retain its dominance. The market dominance can be attributed to its huge product portfolio and highly accurate sequencing instruments. Other established players in the market include PerkinElmer, Inc., Beijing Genomics Institute (BGI), Thermo Fisher Scientific, Inc., and Agilent Technologies, Inc.

Key Attributes:

Report Attribute Details
No. of Pages 138
Forecast Period 2024 – 2033
Estimated Market Value (USD) in 2024 $3.87 Billion
Forecasted Market Value (USD) by 2033 $10.98 Billion
Compound Annual Growth Rate 12.2%
Regions Covered Global

Some of the prominent companies in this market are:

  • Agilent Technologies, Inc.
  • Azenta, Inc.
  • BGI Group
  • CD Genomics
  • F. Hoffmann-La Roche Ltd
  • Daicel Corporation
  • Thermo Fisher Scientific, Inc.
  • Danaher Corporation
  • Illumina, Inc.
  • LGC Limited
  • PacBio
  • Revvity, Inc.
  • Psomagen
  • QIAGEN N.V.
  • Takara Bio Inc.

Market Dynamics

Trends: Current and Future Impact Assessment

  • Increasing Number of Targeted Sequencing Products and Services in the Market
  • Increasing Synergistic Partnerships between Market Players

Market Drivers

  • Increasing Demand for High Depth of Coverage in Sequencing
  • Cost and Data Management Benefits of Targeted Sequencing as Compared to WGS

Market Restraints

  • Lack of Advanced Genomic Testing Centers
  • Lack of Knowledge about New Genes

Market Opportunities

  • Increasing Use in Clinical Research and Trials for Better Disease Pathogenesis and/or Clinical Relevance
  • Increasing Adoption in Targeted Therapeutics in Oncology

Targeted Sequencing Workflow

  • Research and Development Review
  • Patent Filing Trend (by Country, Year)
  • Regulatory Landscape

For more information about this report visit https://www.researchandmarkets.com/r/31w9rs

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.

Contacts

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Two Clinical Trials Identify a Better Way to Target Appropriate Antibiotics for Patients Hospitalized With Pneumonia or Urinary Tract Infection

Two Clinical Trials Identify a Better Way to Target Appropriate Antibiotics for Patients Hospitalized With Pneumonia or Urinary Tract Infection




Two Clinical Trials Identify a Better Way to Target Appropriate Antibiotics for Patients Hospitalized With Pneumonia or Urinary Tract Infection

Algorithm driven alerts help identify best antibiotic for patients with common infections in two 59-hospital trials, with implications to reduce antibiotic resistance

NASHVILLE, Tenn. & ORANGE, Calif. & ATLANTA & BOSTON–(BUSINESS WIRE)–Two large multi-state studies uncovered a highly effective way to improve antibiotic selection for patients hospitalized with pneumonia or urinary tract infections (UTI), enabling better antibiotic stewardship in hospitals, according to research studies published today in the Journal of the American Medical Association (JAMA).


Stewardship Prompts to Improve Antibiotic Selection for Pneumonia
Stewardship Prompts to Improve Antibiotic Selection for Urinary Tract Infection

The studies, led by Harvard Pilgrim Health Care Institute, HCA Healthcare and the University of California, Irvine, were funded by the Centers for Disease Control and Prevention (CDC).

Antibiotic resistance, which occurs when germs like bacteria and fungi mutate to defeat the drugs designed to kill them, is a major public health threat. Helping clinicians tailor antibiotic prescriptions to individual patients can improve patient outcomes by preserving healthy bacteria in the body and reducing the risk of future antibiotic resistance. The two newly published studies, the INSPIRE Pneumonia and UTI Trials, involved more than 220,000 patients with pneumonia or UTI in 59 HCA Healthcare hospitals. In half of the hospitals, clinicians were given algorithm driven computerized alerts with information about the best antibiotic match for an individual patient at the moment antibiotics were being prescribed. This resulted in a better match for 28% of pneumonia patients and 17% of patients with UTI when compared to hospitals where physicians were not provided with alerts according to the trials.

The alerts used patient characteristics from the electronic medical record as well as hospital and location-specific data to determine the patient’s risk for an antibiotic-resistant infection. Assessment of risk was based on pre-trial data from more than 200,000 HCA Healthcare patients with pneumonia and UTI. Physicians treating patients with a low risk for antibiotic-resistant bacteria were prompted to give standard-spectrum antibiotics.

“Pneumonia and urinary tract infections are two of the most common infections requiring hospitalization and a major reason for overuse of broad-spectrum antibiotics,” said Sujan Reddy, MD, Medical Officer in the Epidemiology, Research and Innovations Branch of CDC’s Division of Healthcare Quality Promotion. “The INSPIRE trials have found a highly effective way to help physicians follow treatment recommendations to optimize antibiotic selection for each patient. These trials show the value of harnessing electronic health data to improve best practice.”

Physicians often choose extended-spectrum antibiotics that cover a very broad range of bacteria out of concern that their patients could be sick with antibiotic-resistant bacteria. The INSPIRE trials identified patients with low risk for antibiotic resistance and prompted physicians to order standard-spectrum antibiotics if extended-spectrum antibiotics were being ordered. The trials found that giving physicians real-time information about their patients’ risk for antibiotic resistance worked significantly better to align antibiotic prescribing with current Infectious Diseases Society of America treatment recommendations.

“The right information at the right time can improve physician antibiotic selection,” said Shruti Gohil, MD, MPH, Assistant Professor in the Division of Infectious Diseases at the University of California, Irvine School of Medicine. “Many different bacteria can cause pneumonia or UTI, and picking the best matched antibiotic can be a challenge. Results from these trials show that giving physicians an alert informing them of their patient’s actual risk for antibiotic resistance can help them choose the best antibiotic and reduce extended-spectrum antibiotic use.”

The INSPIRE trials were ongoing when the COVID-19 pandemic began. The trials showed continued beneficial effects in antibiotic selection when other hospitals in the nation were reporting large increases in use of extended-spectrum antibiotics. Part of this benefit is attributed to having an automated prompt that continues to work when hospital resources and staff attention are diverted.

The 59 participating community hospitals spanned 12 states and are part of HCA Healthcare, the largest private inpatient healthcare system in the U.S. The size of the studies involving a wide breadth of community hospitals supports the likelihood that results are applicable to hospitals across the country.

“HCA Healthcare is committed to excellence and innovation in delivering high-quality healthcare, and we are honored to continue our longstanding collaboration with the CDC, Harvard and UCI to leverage our health system’s scale to answer clinical questions for the benefit of patients,” said Kenneth Sands, MD, MPH, chief epidemiologist at HCA Healthcare. “We began using this groundbreaking technology and workflow in the hospitals where we tested it, and have since implemented it across our entire system to improve care for individual patients while also contributing to our growing body of work supporting appropriate antibiotic use everywhere.”

The studies were conducted through a scientific consortium including HCA Healthcare, Harvard Medical School’s Department of Population Medicine at the Harvard Pilgrim Health Care Institute, the University of California, Irvine and the Centers for Disease Control and Prevention.

Additional information about the INSPIRE Pneumonia and UTI Trials can be found in the following JAMA author interview podcast.

Editorial: Harnessing the Electronic Health Record to Improve Empiric Antibiotic Prescribing
Author Interview Podcast

About Centers for Disease Control and Prevention

Whether diseases start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC’s world-leading experts protect lives and livelihoods, national security and the U.S. economy by providing timely, commonsense information, and rapidly identifying and responding to diseases, including outbreaks and illnesses. CDC drives science, public health research, and data innovation in communities across the country by investing in local initiatives to protect everyone’s health.

About Harvard Pilgrim Health Care Institute’s Department of Population Medicine

The Harvard Pilgrim Health Care Institute’s Department of Population Medicine is a unique collaboration between Harvard Pilgrim Health Care and Harvard Medical School. Created in 1992, it is the first appointing medical school department in the United States based in a health plan. The Institute focuses on improving health care delivery and population health through innovative research and education, in partnership with health plans, delivery systems, and public health agencies. Point32Health is the parent company of Harvard Pilgrim Health Care and Tufts Health Plan. Follow us on Twitter and LinkedIn.

About HCA Healthcare

Nashville-based HCA Healthcare is one of the nation’s leading providers of healthcare services comprising 186 hospitals and approximately 2,400 ambulatory sites of care, including surgery centers, freestanding ERs, urgent care centers, and physician clinics, in 20 states and the United Kingdom. With its founding in 1968, HCA Healthcare created a new model for hospital care in the United States, using combined resources to strengthen hospitals, deliver patient-focused care and improve the practice of medicine. With a robust system for analyzing clinical data across large and diverse patient populations, HCA Healthcare is a leader in pragmatic research like the Swap Out, ABATE and REDUCE MRSA trials that can help identify new standards of care. HCA Healthcare is a learning health system that uses its more than 43 million annual patient encounters to advance science, improve patient care and save lives.

About UCI Health

UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system in Orange County. Patients can access UCI Health at primary and specialty care offices across Orange County and at its main campus, UCI Medical Center in Orange, Calif. The 459-bed, acute care hospital, listed among America’s Best Hospitals by U.S. News & World Report for 22 consecutive years, provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation services. UCI Medical Center is home to Orange County’s only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center and regional burn center. UCI Health serves a region of nearly 4 million people in Orange County, western Riverside County and southeast Los Angeles County. Follow us on Facebook, Instagram, LinkedIn and Twitter.

Contacts

HCA HEALTHCARE:

Investor Contact

Frank Morgan

615-344-2688

Media Contact

Harlow Sumerford

615-344-1851

HARVARD PILGRIM HEALTH CARE INSTITUTE:
Maya Dutta-Linn

Maya_Dutta-Linn@hphci.harvard.edu

Jessica Meuleman

Jessica_Meuleman@hphci.harvard.edu

CENTERS FOR DISEASE CONTROL AND PREVENTION:
Martha Sharan

404-998-1787

msharan@cdc.gov

UCI HEALTH:
Sophia Papa

661-369-6968

spapa@hs.uci.edu

 

Global Generic Drugs Strategic Research Report 2024: Market to Reach $671.5 Billion by 2030 – Small-molecule Generic Drugs Account for a Lion’s Share, Biosimilars Exhibit Fastest Growth – ResearchAndMarkets.com

Global Generic Drugs Strategic Research Report 2024: Market to Reach $671.5 Billion by 2030 – Small-molecule Generic Drugs Account for a Lion’s Share, Biosimilars Exhibit Fastest Growth – ResearchAndMarkets.com




Global Generic Drugs Strategic Research Report 2024: Market to Reach $671.5 Billion by 2030 – Small-molecule Generic Drugs Account for a Lion’s Share, Biosimilars Exhibit Fastest Growth – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Generic Drugs – Global Strategic Business Report” report has been added to ResearchAndMarkets.com’s offering.


Global Generic Drugs Market to Reach $671.5 Billion by 2030

The global market for Generic Drugs estimated at US$430.2 Billion in the year 2023, is projected to reach a revised size of US$671.5 Billion by 2030, growing at a CAGR of 5.7% over the analysis period 2023-2030.

The global economic update coincides with a rising demand for generic painkillers, reflecting the growing significance of generic drugs in the pharmaceutical market. Competition among key players is highlighted, with market share percentages and competitive market presence outlined for 2023. Despite promising opportunities, sustaining success in this market requires strategic approaches. Challenges such as pricing dynamics and accessibility persist, but recent market activity suggests ongoing developments in response to these challenges.

Small-Molecule Generics, one of the segments analyzed in the report, is projected to record 4.2% CAGR and reach US$538.8 Billion by the end of the analysis period. Growth in the Biosimilars segment is estimated at 15.3% CAGR for the next 8-year period.

The U.S. Market is Estimated at $130.2 Billion, While China is Forecast to Grow at 7.1% CAGR

Both North America and Europe are key players in this sector, while the Asia-Pacific region emerges as a hotspot for rapid growth. India stands out as a significant market, particularly for small-molecule generic drugs, although biosimilars are also experiencing notable growth.

The Generic Drugs market in the U.S. is estimated at US$130.2 Billion in the year 2023. China, the world’s second largest economy, is forecast to reach a projected market size of US$126.8 Billion by the year 2030 trailing a CAGR of 7.1% over the analysis period 2023 to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 4.2% and 5% respectively over the 2023-2030 period. Within Europe, Germany is forecast to grow at approximately 4.9% CAGR.

Key Attributes:

Report Attribute Details
No. of Pages 711
Forecast Period 2023 – 2030
Estimated Market Value (USD) in 2023 $430.2 Billion
Forecasted Market Value (USD) by 2030 $671.5 Billion
Compound Annual Growth Rate 6.6%
Regions Covered Global

MARKET OVERVIEW

  • Global Economic Update
  • Demand for Generic Pain Killers Rises
  • A Prelude to Generic Drugs
  • Generic Drugs Market Set for a Rapid Growth
  • North America and Europe Dominate, Asia-Pacific to Exhibit the Fastest Growth
  • India- A Significant Market
  • Small-molecule Generic Drugs Account for a Lion’s Share, Biosimilars Exhibit Fastest Growth
  • Exciting Times for Biosimilars
  • Competition
  • Generic Drugs – Global Key Competitors Percentage Market Share in 2023 (E)
  • Competitive Market Presence – Strong/Active/Niche/Trivial for Players Worldwide in 2023 (E)
  • Market Opportunities
  • Strategies to Sustain Success
  • The Future of Generics & Biosimilars Look Bright amid Persistent Barriers
  • Market Challenges
  • Factors Affecting Prices & Accessibility
  • Recent Market Activity
  • BRANDS

MARKET TRENDS & DRIVERS

  • Generic Drugs Enjoy Adrenaline Rush with Regulatory & Scientific Support
  • R&D & Innovation Push
  • Efforts to Eliminate Barriers to Generics Development
  • Regulatory & Scientific Collaboration as Key
  • FDA’s Generic Drug User Free Program
  • Policy Support to Generic Drugs: Clearing Road to Affordable Access to Quality Medicines
  • Savings in Billions
  • Taking GDUFA to Next Level
  • Pushing Competition through ANDAs
  • Patent Expiries Set to Widen the Addressable Market for Generic Drugs
  • Patent Expiries of Select Drugs in 2020
  • Patent Expiries of Select Drugs in 2021
  • Patent Expiries of Select Drugs in 2022
  • Patent Expiries of Select Drugs in 2023
  • Patent Expiry of Select Major Drugs in the US: 2020-2023
  • Robust Demand for Pharmaceutical Drugs Drives Demand for Generic Drugs
  • Cost Containment Measures Put Focus on Generics
  • Small Molecule Generics Represent the Dominant Segment
  • Specialty Generic Drugs Gain Popularity
  • Specialty Generics – The Way to Success Amid Challenges
  • Factors that can Provide Competitive Edge
  • Increasing Demand for Biosimilars, Driven by Patent Expiry of Major Biopharmaceutical Drugs
  • Patent Expiries of Major Biopharmaceutical Drugs in the US and Europe in the Recent Past
  • Progressive Regulatory Framework Accelerates Product Approvals & Subsequently Market Revenues
  • Specific Guidelines for Biosimilars in Various Countries with Year of Publication
  • Biosimilars Regulatory Agencies in Select Regional Markets
  • Biosimilar Approvals in the US (as of 2023)
  • Biosimilar Approvals in Europe (as of 2023)
  • Rising Healthcare Costs Drive Demand for Generic Drugs
  • World Healthcare Expenditure (In US$ Billion) for the Years 2017-2023
  • Aging Population to Propel the Demand for Generic Drugs
  • Global Aging Population Statistics for the 65+ Age Group in Million by Geographic Region for the Years 2019, 2025, 2035 and 2050
  • Significant Increase in Number of Patients Suffering from Chronic Diseases Fuel Demand for Generic Medicines
  • Global Cost of Chronic Diseases (In US$ Billion) for the Years 2018 and 2030
  • Fatalities by Heart Conditions – Estimated Percentage Breakdown for Cardiovascular Disease, Ischemic Heart Disease, Stroke, and Others
  • Global Cancer Incidence: Number of New Cancer Cases in Million for the Years 2018, 2020, 2025, 2030, 2035 and 2040
  • Number of New Cancer Cases and Deaths (in Million) by Region for 2018
  • US Regulators Struggle to Keep Up with the Global Market
  • Increased Dependency on Non-US Manufacturers
  • Patient Trust and Traceability
  • Drug Supply Shortage Risks
  • Fixing a Broken System
  • Hospitals Teaming Up to Develop Own Generic Drugs to Combat Shortages and High Prices
  • Use of Artificial Intelligence and Machine Learning in Pharmaceutical Manufacturing Witnesses a Surge

FOCUS ON SELECT PLAYERS (Total 255 Featured)

  • Abbott Laboratories
  • Apotex Inc.
  • ASKA Pharmaceutical Co., Ltd.
  • Aspen Pharmacare Holdings Limited
  • AstraZeneca Plc
  • Baxter International Inc.
  • Dr. Reddy’s Laboratories Limited
  • Eli Lilly and Company
  • Endo International plc
  • F. Hoffmann-La Roche AG
  • Fresenius Kabi AG
  • GSK plc
  • H. Lundbeck A/S
  • Incepta Pharmaceuticals Ltd.
  • Lupin Ltd.
  • Novo Nordisk A/S
  • Sandoz International GmbH
  • Sanofi-Aventis U.S. LLC
  • STADA Arzneimittel AG
  • Sun Pharmaceutical Industries Limited
  • Teva Pharmaceutical Industries Ltd.
  • Viatris Inc.

For more information about this report visit https://www.researchandmarkets.com/r/9t2gol

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.

Contacts

ResearchAndMarkets.com

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For E.S.T Office Hours Call 1-917-300-0470

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Antibe Provides Update on CCAA Proceedings

Antibe Provides Update on CCAA Proceedings




Antibe Provides Update on CCAA Proceedings

TORONTO–(BUSINESS WIRE)–$ATBPF–Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSX: ATE) announced that the Company sought an extension of its previously announced stay of proceedings (“Stay”) under the Companies’ Creditors Arrangement Act (the “CCAA”) at a hearing before the Ontario Superior Court of Justice (Commercial List) (the “Court”) on April 18, 2024.


The Court has reserved its decision and extended the Stay pending release of the decision. The Company is requesting to extend the Stay until May 24, 2024 in order to be able to continue engaging with the U.S. Food and Drug Administration with respect to the previously announced hold on the Company’s planned Phase II trial and to determine appropriate next steps.

About Antibe Therapeutics Inc.

Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation therapies to target pain and inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is intended as a safer alternative to opioids and today’s NSAIDs for acute pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com.

Forward Looking Statements

This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, statements concerning the extension of the Stay, payment of amounts due to Nuance under the arbitral award, anticipated engagement with the U.S. Food and Drug Administration concerning the clinical hold on otenaproxesul. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the decision of the Court with respect to the extension of the Stay and any subsequent determinations made by the Court, the Company’s inability to timely execute on its business strategy and timely and successfully complete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals related to its activities, risks associated with drug development generally and those risk factors set forth in the Company’s public filings made in Canada and available on sedarplus.com. The Company assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.

Contacts

Antibe Therapeutics Inc.

Christina Cameron

VP Investor Relations

+1 416-577-1443

christina@antibethera.com

$1.25 Billion Parenteral Nutrition Bags Markets by Chamber Type, Consumer, End User – Global Forecast to 2031 – ResearchAndMarkets.com

$1.25 Billion Parenteral Nutrition Bags Markets by Chamber Type, Consumer, End User – Global Forecast to 2031 – ResearchAndMarkets.com




$1.25 Billion Parenteral Nutrition Bags Markets by Chamber Type, Consumer, End User – Global Forecast to 2031 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Parenteral Nutrition Bags Market by Chamber Type (Single-Chamber Bags, Dual-Chamber Bags, Multi-Chambered Bags), Consumer (Adults, Children), End User (Healthcare Facilities, Pharmacies & Compounding Service Providers) – Global Forecast to 2031” report has been added to ResearchAndMarkets.com’s offering.


The global parenteral nutrition bags market is projected to reach $1.25 billion by 2031, at a CAGR of 6.6% from 2024 to 2031.

This market is driven by the rising global prevalence of malnutrition, the large number of premature births, and the increasing incidence of metabolic disorders. Furthermore, the growing adoption of home healthcare, the rising global geriatric population, and emerging economies provide significant growth opportunities for this market. However, concerns over the infection risks associated with parenteral nutrition restrain the growth of this market. The lack of awareness regarding parenteral nutrition in developing countries is a major challenge impacting the growth of the parenteral nutrition bags market.

North America is expected to account for the largest share of the global parenteral nutrition bags market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. This growth is primarily driven by the growing demand for parenteral nutrition due to the prevalence of chronic & infectious diseases, the rising number of premature births, and the growing adoption of home healthcare settings.

Among chamber types, in 2024, the single-chamber parenteral nutrition bags segment is expected to account for the largest share of the parenteral nutrition bags market.

Single-chamber parenteral nutrition bags are designed to compound and store a comprehensive blend of nutritional solutions, including electrolytes, amino acids, lipids, vitamins, carbohydrates, and trace elements within a single compartment for parenteral administration. The large share of the segment is attributed to the wide availability of single-chamber empty bags, high rate of prescription for single-chamber nutrition bags, decreased risk of infection, less prescription & administration errors, and cost-effectiveness as compared to dual or multi-chambered bags.

Among consumers, in 2024, the adults segment is expected to account for the largest share of the parenteral nutrition bags market.

The rising number of surgeries, rising hospitalization rates, the growth of the geriatric population, and the increasing prevalence of gastrointestinal disorders among adults are factors supporting the largest share of the market. For instance, in 2020, the Rome Foundation of Global Epidemiology Study revealed that 40% of people worldwide suffer from diseases of the gut-brain interaction (DGBIs), such as irritable bowel syndrome, functional dyspepsia, and functional abdominal pain syndrome, among others. Most of these patients would require parenteral nutrition bags for the intake of the required nutrition.

Among end users, in 2024, the healthcare facilities segment is expected to account for the largest share of the parenteral nutrition bags market.

The large market share of this segment is attributed to factors such as a large number of patients visiting hospitals and clinics for disease diagnosis and treatment, growing disease burden, an associated rise in the rates of prescription for parenteral nutrition, and the presence of advanced compounding equipment in the hospital associated compounding pharmacies.

Market Insights

Factors Affecting Market Growth

  • Impact Analysis of Market Dynamics
  • Factor Analysis

Key Trends

  • Growing Adoption of Home Healthcare
  • Growing Use of Ethylene Vinyl Acetate (EVA) in Parenteral Applications

Regulatory Analysis

  • North America
  • U.S.
  • Canada
  • Europe
  • Asia-Pacific
  • China
  • Japan
  • India
  • Latin America
  • Brazil
  • Mexico
  • Middle East & Africa

Porter’s Five Forces Analysis

Company Profiles

  • B. Braun SE (Germany)
  • Baxter International, Inc. (U.S.)
  • Fresenius Kabi AG (Germany)
  • GVS S,p.A. (Italy)
  • Grifols, S.A. (Spain)
  • Technolflex (France)
  • RENOLIT Healthcare (Germany)
  • Valmed s.r.l (Italy)
  • HEMEDIS GmbH (Germany)
  • INFRA Srl (Italy)
  • Beijing L&Z Medical Technology Development Co., Ltd.(China)
  • Boen Healthcare Co., Ltd. (China)
  • AdvaCare Pharma (U.S.)
  • Diffuplast S.r.l. (Italy)

Scope of the Report

Parenteral Nutrition Bags Market Assessment – by Chamber Type

  • Single-Chamber Parenteral Nutrition Bags
  • Dual-Chamber Parenteral Nutrition Bags
  • Multi-Chambered Parenteral Nutrition Bags

Parenteral Nutrition Bags Market Assessment – by Consumer

  • Adults
  • Children

Parenteral Nutrition Bags Market Assessment – by End User

  • Healthcare Facilities
  • Pharmacies and Compounding Service Providers

Parenteral Nutrition Bags Market-by Geography

  • North America
  • Europe
  • Asia-Pacific (APAC)
  • Latin America
  • Middle East & Africa

For more information about this report visit https://www.researchandmarkets.com/r/cfkt6i

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Executive War College to Address, Clinical Laboratories’ and Genetic Testing Firms’ Perfect Storm, involving FDA’s Proposed LDT Rule, Payers Requiring Z-Codes on Genetic Test Claims, and Revisions to CLIA Regulations

Executive War College to Address, Clinical Laboratories’ and Genetic Testing Firms’ Perfect Storm, involving FDA’s Proposed LDT Rule, Payers Requiring Z-Codes on Genetic Test Claims, and Revisions to CLIA Regulations




Executive War College to Address, Clinical Laboratories’ and Genetic Testing Firms’ Perfect Storm, involving FDA’s Proposed LDT Rule, Payers Requiring Z-Codes on Genetic Test Claims, and Revisions to CLIA Regulations

AUSTIN, Texas–(BUSINESS WIRE)–#CLIA–Three major challenges poised to confront the nation’s clinical laboratories, genetic test companies, and anatomic pathology laboratories will be major topics when a top-flight roster of lab experts, innovators, and lab leaders gather in New Orleans April 30-May 1, 2024, for the 29th annual Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. The event takes place at the Hyatt Regency Hotel just a few minutes from the historic French Quarter and registrations point to the largest event in its history.




“This perfect storm is the simultaneous arrival of three disruptive forces hitting the medical laboratory market,” stated Robert L. Michel, producer of Executive War College and Editor-In-Chief of The Dark Report https://www.darkreport.com. One is the Food and Drug Administration’s (FDA) proposed rule https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests to regulate laboratory developed tests (LDTs). The second is requirements by private payers that genetic test claims include Z-Codes. The third is a major rewrite and update to the CLIA regulations to which all labs must comply. Each will be disruptive to nearly all the nation’s clinical laboratories.

“To help lab leaders and pathologists prepare for this perfect storm, we’ve assembled a unique trifecta of speakers,” continued Michel. “For the first time in the history of medical laboratory testing—at one time and at one place—we are presenting the leading expert in each of these three disruptive forces. Each will speak at the same plenary session and will later conduct an open forum, as described below.”

Perfect Storm Is FDA’s LDT Rule, Private Payer Z-Code Requirements, and Revisions to CLIA Regulations

To give clinical labs and genetic testing companies an inside track to prepare for the perfect storm’s three power forces, this unique trifecta of expert speakers includes:

  • Tim Stenzel, MD https://www.linkedin.com/in/timothy-stenzel-md-phd-20204521/, CEO, Grey Haven, LLC, retired former director of the FDA’s Office of In Vitro Devices: He will discuss the FDA’s pending FDA rule, harmonization of ISO 13485 (Medical Devices), and the FDA Memo on Reclassification of IVD tests.
  • Gabriel Bien-Willner, MD, PhD https://www.linkedin.com/in/gabriel-bien-willner-52a332117/, Chief Medical Officer, Palmetto GBA’s MolDx/Z-Code Program: He will address developments involving the MolDx and Z-Code program and the differences in how federal health programs and private payers are using Z-Codes in their genetic testing guidelines and claims processing.
  • Reynolds Salerno, PhD https://www.cdc.gov/cliac/members/salerno.html, Director, Division of Laboratory Systems (DLS), U.S. Centers for Disease Control and Prevention (CDC): He will cover major initiatives involving connecting clinical labs with public health labs, the DLS lab resource center, and the progress of the CLIAC Committee in updating and developing major revisions to the regulations of the Clinical Laboratory Improvement Amendments (CLIA). The notable element here is a recommendation to define lab test data (including genetic sequence data) as a sample that must be handled in compliance with CLIA regulations.
  • Lâle White https://www.xifin.com/about-us/#lale-white, CEO, XiFin, Inc.: She will discuss how the three forces of the perfect storm will play out within the wider changes happening to the U.S. healthcare system and the clinical laboratory testing marketplace.

Now in its 29th year and stronger than ever, Executive War College is the nation’s largest, most respected gathering on clinical lab management and operations— attracting the attendance of senior lab executives, administrators, and pathologists from all over the world who gather to learn, network, and collaborate with thought leaders, experts, and analysts in developing the right strategies for their labs. It’s why major lab industry companies actively support this unique gathering, including organizations such as XiFin, Inc., Leica BioSystems, TELCOR, Beckman Coulter, Cleveland Clinic, ARUP Laboratories, COLA, and the College of American Pathologists.

In addition to more than 90 information-packed presentations comprising an enlightening and expansive range of topics, Executive War College 2024 will also feature a 3rd day with post conference workshops and exhibits that address whole genome sequencing, digital pathology, artificial intelligence, Lean, and revenue cycle management.

“Our expert content is what differentiates the Executive War College and provides true value to our attendees,” Michel said. “The event is fine-tuned to provide real-world solutions for laboratories and pathology practices to be successful. We will navigate, propose, and present solutions to the urgent issues that continue to challenge the clinical laboratory industry, including staffing, rising costs, tightening margins, regulations, and more.”

A maximum-capacity attendance is expected at this year’s 29th Anniversary Executive War College. To register and for more information on Executive War College 2024, visit http://www.executivewarcollege.com. You may also contact Amanda Curtis at 512-264-7103.

About THE DARK REPORT

Established in 1995, THE DARK REPORT is the leading source of exclusive business intelligence for laboratory CEOs, COOs, CFOs, Pathologists and Senior industry executives. It is widely read by leaders in laboratory medicine and diagnostics. The Dark Report produces the famous Executive War College on Diagnostic, Laboratory, and Pathology Management every spring, which showcases innovations by the nation’s and globe’s leading laboratory organizations. Dark Daily is an Internet-based e-briefing intelligence service, read worldwide by thought leaders in laboratory and pathology management.

Contacts

Amanda Curtis

acurtis@darkreport.com

Surmodics to Report Second Quarter of Fiscal 2024 Financial Results on May 1

Surmodics to Report Second Quarter of Fiscal 2024 Financial Results on May 1




Surmodics to Report Second Quarter of Fiscal 2024 Financial Results on May 1

Earnings Conference Call and Webcast Will Begin at 7:00 am (CT)

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–#EarningsCall–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today announced that second quarter of fiscal year 2024 financial results will be released before the market opens on Wednesday, May 1.


Management will host a live webcast and conference call at 7:00 a.m. CT (8:00 a.m. ET) on Wednesday, May 1, to discuss the second quarter fiscal 2024 financial results and accomplishments and host a question-and-answer session. To access the webcast, please go to “Events & Presentations” under the “Investors” section of the Company’s website at https://surmodics.gcs-web.com/events-and-presentations, and click on the webcast icon under “Upcoming Events.” To listen to the live teleconference, please dial 877-407-8293 (international callers may dial +1 201-689-8349) and provide event ID 13745933.

An audio replay of the conference call will be available beginning at approximately 11 a.m. CT on Wednesday, May 1, until approximately 11 a.m. CT on Wednesday, May 15, and can be accessed by dialing 877‑660‑6853 (international callers may dial 201-612-7415) and entering access ID 13745933. In addition, the webcast and transcript will be archived on the Company’s website following the call.

About Surmodics, Inc.

Surmodics is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development, and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics’ website is not part of this press release or part of any filings that the company makes with the Securities and Exchange Commission.

Contacts

Surmodics Investor Inquiries:

Jack Powell, Investor Relations

ir@surmodics.com

La Jolla Institute for Immunology and RevolKa started a Research Collaboration

La Jolla Institute for Immunology and RevolKa started a Research Collaboration




La Jolla Institute for Immunology and RevolKa started a Research Collaboration

LJI and RevolKa will Research Nex-gen Vaccine Antigens by using AI-driven Protein Engineering Platform

TOKYO–(BUSINESS WIRE)–RevolKa Ltd. (Norio Hamamatsu, President & CEO), a venture-backed biotech company providing a game-changing protein engineering technology platform and La Jolla Institute for Immunology (LJI) (Erica Saphire, President & CEO) agreed to start a research collaboration to create antigens for the next-generation vaccines to deliver innovative solutions to unmet medical need in infectious diseases. RevolKa has a robust directed protein evolution technology integrated with artificial intelligence (AI), called aiProtein®. LJI and RevolKa will synergize LJI’s deep knowledge of immunology and RevolKa’s power of AI-driven protein engineering. Details of this collaboration and financial terms were not disclosed.


About aiProtein® Technology

RevolKa’s proprietary technology, aiProtein® is an AI-assisted directed evolution of proteins. Naturally occurring protein is a linear polymer of amino acids and their derivatives, which folds into a tertial structure through internal complex atomic interactions to show biological function. Proteins have evolved to biologically functional molecules over hundreds of millions of years. The relationship between protein sequence, structure, and function in those highly functioned molecules remains poorly understood to rationally design a protein sequence for a particular function. Our AI engine is trained with sequence-function relationship data to statistically predict sequences for an evolved protein function. Furthermore, aiProtein® can evolve more than two functions simultaneously. This technology is a powerful and cost-effective tool for the creation of novel and highly-optimized proteins for pharmaceutical and industrial uses.

About RevolKa Ltd.

RevolKa is a venture-backed biotechnology company founded in April 2021 by academic and industry experts in biotechnology and artificial intelligence. Our mission is to create novel proteins useful for therapeutics and industries by using our own proprietary technology platform, aiProtein® to contribute to human well-being. The name “RevolKa” is derived from the Latin word for evolution, “evolutio” and the Ainu (an indigenous Japanese people) word for raise, “reska”. RevolKa’s headquarters are located in Tokyo, Japan with laboratories located in Sendai. The company’s investors include D3 LLC, DEEPCORE Inc., Tohoku University Venture Partners, and SBI investment Co., Ltd. For more information, visit https://www.revolka.com/en/.

About La Jolla Institute for Immunology

The La Jolla Institute for Immunology is dedicated to understanding the intricacies and power of the immune system to that we may apply to that knowledge to promote human health and prevent a wide range of diseases. Since its founding in 1988 as an independent, nonprofit research organization, the Institute has made numerous advances leading towards its goal: Life without Disease®. For more information, visit https://www.lji.org/.

Contacts

RevolKa Ltd.

Ayumi Iwase

Email: info@revolka.co.jp
TEL: +81-3-5990-9858

U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease

U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease




U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease

ENTYVIO is Now Available in the U.S. in Both IV and Subcutaneous Administrations for Maintenance Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease


OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) ENTYVIO.1 The subcutaneous administration of ENTYVIO was also approved by FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC) and is available in the U.S. as a single-dose prefilled pen (ENTYVIO Pen).*

The approval is based on the VISIBLE 2 Study (SC CD Trial), a Phase 3, randomized, double-blind, placebo-controlled trial, which assessed the safety and efficacy of an SC formulation of ENTYVIO as maintenance therapy in adult patients with moderately to severely active CD who had clinical response** at Week 6 following two doses of open-label vedolizumab intravenous therapy at Weeks 0 and 2.1 The primary endpoint was clinical remission*** at Week 52, which was defined as a total Crohn’s Disease Activity Index (CDAI) score of ≤150.

“Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve remission. In VISIBLE 2, about half of patients treated with ENTYVIO SC achieved long-term clinical remission,” said Timothy Ritter, MD, senior medical director, Department of Research and Education, GI Alliance Research and assistant professor of medicine, TCU School of Medicine. “The data from VISIBLE 2 reaffirm the well-established efficacy profile of ENTYVIO, regardless of route of administration.”

In VISIBLE 2, a total of 409 patients were randomized at Week 6 in a double-blind fashion (2:1) to ENTYVIO 108 mg administered by SC injection or placebo every 2 weeks.1 Eligible patients included patients who had experienced an inadequate response to, loss of response to, or intolerance to at least one of the following: corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate), or tumor necrosis factor (TNF) blockers (including primary non-responders).

A statistically significant proportion of patients receiving ENTYVIO SC 108 mg maintenance therapy administered every 2 weeks achieved long-term clinical remission*** compared to patients receiving placebo (48% vs. 34%; p<0.01) at Week 52.1 In clinical studies, the ENTYVIO SC safety profile was generally consistent with the known safety profile of ENTYVIO IV, with the addition of injection site reactions (including injection site erythema, rash, pruritus, swelling, bruising, hematoma, pain, urticaria and edema) as an adverse reaction for ENTYVIO SC. The most common adverse reactions reported with ENTYVIO IV (incidence ≥3% and ≥1% higher than placebo) were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

“The approval of subcutaneous ENTYVIO in Crohn’s disease delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or Crohn’s disease, while also providing them flexibility and choice of route of administration. With ENTYVIO Pen, patients have the option of administering their maintenance treatment at home or on the go,” said Brandon Monk, senior vice president, head, U.S. Gastroenterology Business Unit, Takeda. “Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”

*Please refer to “U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis”, dated September 27, 2023.

**Clinical response is defined as a ≥70-point decrease in Crohn’s Disease Activity Index (CDAI) score from baseline (Week 0).1

***Clinical remission is defined as CDAI score of ≤150 at Week 52.1

Takeda does not expect a material impact on the consolidated financial statements as a result of this approval.

About ENTYVIO (vedolizumab)

Vedolizumab is a biologic therapy and is approved for intravenous (IV) and subcutaneous (SC) administration (approvals vary by market).1,2 Vedolizumab SC has been granted marketing authorization in the United States, European Union and more than 50 countries. Vedolizumab IV has been granted marketing authorization in more than 70 countries, including the United States and European Union. Globally, vedolizumab IV and SC have more than one million patient years of exposure to date.3 Vedolizumab is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).4 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.5 The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.4 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis and Crohn’s disease.4,6,7 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.4

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.

WARNINGS AND PRECAUTIONS

  • Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
  • Infections: Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
  • Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
  • Liver Injury: There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
  • Live and Oral Vaccines: Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) were: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities, and injection site reactions with subcutaneous administration.

DRUG INTERACTIONS

Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products and with TNF blockers. Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed.

INDICATIONS

Adult Ulcerative Colitis (UC):

ENTYVIO is indicated in adults for the treatment of moderately to severely active UC.

Adult Crohn’s Disease (CD):

ENTYVIO is indicated in adults for the treatment of moderately to severely active CD.

DOSAGE FORMS & STRENGTHS:

  • ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab
  • ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab

Please click for Full U.S. Prescribing Information.

About Ulcerative Colitis and Crohn’s Disease

Ulcerative colitis (UC) and Crohn’s disease (CD) are two of the most common forms of inflammatory bowel disease (IBD).8 Both UC and CD are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal tract.9,10 UC only involves the large intestine as opposed to CD, which can affect any part of the GI tract from mouth to anus.11,12 CD can also affect the entire thickness of the bowel wall, while UC only involves the innermost lining of the large intestine.11,12 UC can present with symptoms of abdominal discomfort or loose bowel movements, including blood.11,13 CD can present with symptoms of abdominal pain, diarrhea, and weight loss.12 The cause of UC or CD is not fully understood; however, research suggests that an interplay between environmental factors, genetics, and intestinal microbiota may contribute to the development of UC or CD.11,14,9

Takeda’s Commitment to Gastroenterology

With this latest milestone, Takeda continues to demonstrate a commitment to meeting the very real needs of those living with gastrointestinal (GI) diseases. We believe that GI and liver diseases are life-disrupting conditions. Beyond a fundamental need for effective treatment options, we understand that improving patients’ lives also depends on their needs being recognized. With more than 35 years of experience in gastroenterology, Takeda has made significant strides in addressing patient needs with treatments for inflammatory bowel disease (IBD), eosinophilic esophagitis (EoE), acid-related diseases, short bowel syndrome (SBS) and motility disorders. We are making significant strides toward closing the gap on new areas of unmet need. Together with researchers, patient groups and more, we are working to advance scientific research and clinical medicine in GI.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

References

1 ENTYVIO (vedolizumab) Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc.

2 ENTYVIO Summary of Product Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/documents/product-information/entyvio-epar-product-information_en.pdf. Last updated: April 2023. Last accessed: January 2024.

3 Data on file. Takeda Pharmaceuticals.

4 Soler D, Chapman T, Yang LL, et al. J Pharmacol Exp Ther. 2009;330(3):864-875.

5 Briskin M, Winsor-Hines D, Shyjan A, et al. Am J Pathol. 1997;151:97‑110.

6 Eksteen B, Liaskou E, Adams DH. Inflamm Bowel Dis. 2008;14:1298‑1312.

7 Wyant T, Fedyk E, Abhyankar B. J Crohns Colitis. 2016;10(12):1437-1444.

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US-VED-2568v1.0 04/24

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