Samsung Bioepis Begins Commercialization of BYOOVIZ®, Biosimilar to Lucentis (Ranibizumab), in Europe




Samsung Bioepis Begins Commercialization of BYOOVIZ®, Biosimilar to Lucentis (Ranibizumab), in Europe

• Samsung Bioepis completes full transfer of commercial rights from Biogen back to Samsung Bioepis for BYOOVIZ^®
• BYOOVIZ becomes the fourth biosimilar directly commercialized by Samsung Bioepis in Europe, following EPYSQLI^® (eculizumab), OBODENCE^® (denosumab), and XBRYK^® (denosumab)
• Pre-filled syringe (PFS) presentation to become available in Europe in the second quarter of 2026

INCHEON, Korea–(BUSINESS WIRE)–#biosimilars–Samsung Bioepis Co., Ltd. today announced that the company has begun direct commercialization of BYOOVIZ^®, a biosimilar to Lucentis¹ (ranibizumab), in Europe. Samsung Bioepis has been working to ensure seamless transfer of commercial rights from Biogen back to Samsung Bioepis, and BYOOVIZ will now be available as a Samsung Bioepis brand across multiple European countries.

“This is a significant milestone for Samsung Bioepis as the company continues to strengthen its presence in Europe by expanding its portfolio of directly commercialized products. Leveraging the past three years of experience with EPYSQLI (eculizumab) and the newly launched OBODENCE (denosumab) and XBRYK (denosumab) in Europe, we will continue on our journey to become a fully integrated biopharmaceutical company with end-to-end capabilities from development to commercialization,” said Antonio Rito, Vice President and Head of Europe, at Samsung Bioepis. “We will work closely with payers and healthcare professionals to ensure seamless access to our biosimilar medicines for patients in need.”

BYOOVIZ was first approved by the European Commission (EC) in August 2021 as a single use vial for intravitreal use (0.5 mg/0.05 ml) for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV). In November 2025, European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for BYOOVIZ pre-filled syringe (PFS). The PFS presentation is expected to be available on the European market starting in the second quarter of 2026.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

Contacts

MEDIA CONTACT
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com

EU CUSTOMER SERVICE CONTACT
EU Customer Service, css.sbeu@samsung.com

AI-based Digital Pathology Market Intelligence Report, 2025-2035, Featuring Aiforia Technologies, Ibex Medical Analytics, Indica Labs, PathAI, Roche, Visiopharm and Many Other Key Players – ResearchAndMarkets.com




AI-based Digital Pathology Market Intelligence Report, 2025-2035, Featuring Aiforia Technologies, Ibex Medical Analytics, Indica Labs, PathAI, Roche, Visiopharm and Many Other Key Players – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “AI-based Digital Pathology Market: Industry Trends and Global Forecasts, Till 2035 – Distribution by Type of Neural Network, Type of Assay, Type of End-User, Area of Application, Target Disease Indication and Key Geographies” has been added to ResearchAndMarkets.com’s offering.

The global AI-based digital pathology market is projected to expand from USD 1.01 billion in the current year to USD 2.32 billion by 2035, reflecting a CAGR of 8.7%. This growth is driven by technological advancements and an emphasis on precision medicine that have enhanced digital pathology techniques, allowing for more efficient quantitative and qualitative assessments.

Market Dynamics and Opportunities

The adoption of AI in digital pathology has revolutionized slide examination, replacing traditional microscopy. Digitizing glass slides facilitates rapid transmission from diagnostic centers to pathologists, significantly improving tissue micro-environment comprehension. AI integration in diagnostics allows tailored treatment strategies and patient categorization, fostering a transformative care delivery model across pathology subdomains.

Market Insights

Currently, about 80 companies offer AI-based digital pathology services worldwide, primarily to research institutes and diagnostic facilities. Companies provide a range of AI-based solutions, enhanced through proprietary products chiefly employed in research and diagnostics.

The market has attracted substantial investment, with approximately USD 2 billion invested over 60 funding events. Factors such as the integration of AI into clinical workflows and increased global adoption of these tools have propelled market growth, anticipated to maintain an 8.70% annualized rate till 2035.

Key Insights:

• The demand for AI-based digital pathology solutions is growing, with convolutional neural networks leading the market due to their extensive application range. Ki67 assays dominate the market due to high relevance in cell proliferation.
• Research institutes currently hold the largest market share, with diagnostic applications predicted to show higher growth rates. Breast cancer is the primary disease indication, capturing the largest market share.
• Geographically, North America holds the most significant market share, while Europe’s market is expected to grow at a higher CAGR.

Featured Players:

• Aiforia Technologies
• Akoya Biosciences
• Ibex Medical Analytics
• Indica Labs
• Paige
• PathAI
• PROSCIA
• Roche Tissue Diagnostics
• Visiopharm

Research and Analysis

The report includes extensive market sizing and opportunity analysis, segmentation by neural network type, assay, end-user, and target disease indication. It also provides a thorough company landscape evaluation and competitiveness analysis, focusing on market leaders and emerging players.

Reasons to Buy:

• Comprehensive market analysis with detailed revenue projections and insights into competitive dynamics for strategic decision-making.
• Access to key market trends and growth prospects, empowering stakeholders to capitalize on emerging opportunities.

Additional Benefits:

• Complimentary PPT Insights Packs and Excel Data Packs
• Free content customization and report updates
• Detailed walkthrough sessions with the research team

Key Attributes

Key Topics Covered

1. PREFACE

• 1.1. Chapter Overview
• 1.2. Market Segmentations
• 1.3. Research Methodology
• 1.4. Key Questions Answered
• 1.5. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

• 3.1. Chapter Overview
• 3.2. Artificial Intelligence in Digital Pathology
• 3.3. Workflow of AI-based Digital Pathology
• 3.4. Applications of AI-based Digital Pathology Solutions
• 3.5. Regulatory Requirements Focused on AI-based Digital Pathology
• 3.6. Challenges Associated with the Use of AI in Digital Pathology
• 3.7. Future Perspectives

4. AI-BASED DIGITAL PATHOLOGY: MARKET LANDSCAPE

• 4.1. Chapter Overview
• 4.2. AI-based Digital Pathology Providers: Developers Landscape
• 4.3. AI-based Digital Pathology Providers: Market Landscape

5. AI-BASED DIGITAL PATHOLOGY MARKET: KEY INSIGHTS

• 5.1. Chapter Overview

6. COMPANY PROFILES

• 6.1. Chapter Overview
• 6.2. PathAI
• 6.3. Paige
• 6.4. Akoya Biosciences
• 6.5. PROSCIA
• 6.6. Visiopharm
• 6.7. Roche Tissue Diagnostics
• 6.8. Aiforia Technologies
• 6.9. Indica Labs
• 6.10. Ibex Medical Analytics

7. COMPANY COMPETITIVENESS ANALYSIS

• 7.1. Chapter Overview
• 7.2. Assumptions and Key Parameters
• 7.3. Methodology

8. FUNDING AND INVESTMENTS

• 8.1. Chapter Overview
• 8.2. Types of Funding

9. DEMAND ANALYSIS

• 9.1. Chapter Overview
• 9.2. Scope and Methodology

10. MARKET SIZING AND OPPORTUNITY ANALYSIS

• 10.1. Chapter Overview
• 10.2. Forecast Methodology and Key Assumptions

11. CONCLUDING REMARKS

12. EXECUTIVE INSIGHTS

13. APPENDIX 1: TABULATED DATA

14. APPENDIX II: LIST OF COMPANIES AND ORGANIZATION

A selection of companies mentioned in this report includes, but is not limited to:

• 3D HISTECH
• 50 Partners
• 83North
• 8VC
• ACME Investments
• Act Venture Capital
• Adage
• aetherAI
• Agilent Technologies
• Aiforia
• Akoya Biosciences
• Aktia Nordic Micro Cap
• Alpha Intelligence Capital
• Alverno Laboratories
• aMoon
• AnaPath
• Angels Sante
• APEX Ventures
• Ascend Capital Partners
• ATP
• Augmentiqs
• Augsburg University Hospital
• Aventior
• Axon Diagnostics
• BankInvest
• Bayern Kapital
• BGV
• Biospring Partners
• BioView
• Blue Venture Fund
• Breyer Capital
• Bristol Myers Squibb
• and many more!

For more information about this report visit https://www.researchandmarkets.com/r/g1fqw

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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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Europe Image-Guided Drug Delivery Research Report 2025-2035: $284.1 Million Market Driven by Rising Chronic Disease Burden, Imaging Advancements, and Aging Populations – ResearchAndMarkets.com




Europe Image-Guided Drug Delivery Research Report 2025-2035: $284.1 Million Market Driven by Rising Chronic Disease Burden, Imaging Advancements, and Aging Populations – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Europe Image-Guided Drug Delivery Market: Focus on Technology Type, Application, End User, and Country Analysis – Analysis and Forecast, 2025-2035” report has been added to ResearchAndMarkets.com’s offering.

The Europe image-guided drug delivery market is projected to reach $284.1 million by 2035 from $13.7 million in 2024, growing at a CAGR of 32.01% during the forecast period 2025-2035.

The growing use of IGDD systems throughout Europe and developments in sophisticated imaging drug delivery technologies are fueling the market’s explosive expansion in Europe. By precisely delivering medications to specific disease sites, such as tumors and brain areas, these devices lower systemic toxicity and enhance patient outcomes. Investments in cutting-edge drug delivery platforms that combine MRI, CT, PET, and ultrasound imaging with minimally invasive treatments are being driven by the rising need for targeted medication delivery and precision medicine in Europe.

In Europe, image-guided drug delivery applications are predominantly seen in oncology, neurology, and wound healing, with oncology leading due to rising cancer prevalence. The aging of Europe’s population, the rise in chronic illnesses, and continuous improvements in imaging-guided drug delivery technologies all contribute to the market’s expansion. Additionally, IGDD systems are being adopted more quickly in Europe thanks to government financing for healthcare innovation and favorable regulatory support, making these technologies a crucial component of next-generation precision medicine solutions.

With substantial R&D expenditures in precision-targeted drug delivery technology and established healthcare infrastructure, Germany, France, and the United Kingdom dominate the European image-guided drug delivery industry. Because of increased access to and awareness of healthcare, emerging economies in Eastern Europe are progressively implementing IGDD systems. However, obstacles including high upfront costs, complicated regulations, technical constraints, and privacy concerns about patient data still hinder market penetration and broad adoption.

The Europe IGDD market is projected to achieve strong growth over the next decade, driven by continuous technological advancements and the increasing emphasis on personalized drug delivery. Integrating AI-driven navigation, robotics, and imaging technologies will enhance therapeutic precision, reduce recovery times, and optimize healthcare resources, positioning Europe as a leader in next-generation precision medicine and targeted drug delivery solutions.

Europe Image-Guided Drug Delivery Market Trends, Drivers and Challenges

Market Trends

• Technological Advancements: Integration of imaging modalities such as MRI, CT, PET, and ultrasound with drug delivery systems is enhancing the precision and efficacy of treatments, particularly in oncology and neurology.
• Minimally Invasive Procedures: There is a growing preference for minimally invasive techniques, leading to increased adoption of image-guided therapies that offer reduced recovery times and improved patient outcomes.
• Personalized Medicine: The shift towards personalized treatment plans is fostering the development and adoption of IGDD systems tailored to individual patient profiles.
• Regulatory Support: European regulatory bodies are providing clearer pathways for the approval of innovative drug delivery technologies, facilitating market growth.

Market Drivers

• Rising Incidence of Chronic Diseases: The increasing prevalence of conditions such as cancer and neurological disorders is driving demand for targeted and effective treatment options.
• Advancements in Imaging Technologies: Continuous improvements in imaging modalities are enhancing the accuracy and reliability of IGDD systems, making them more appealing to healthcare providers.
• Aging Population: Europe’s aging demographic is contributing to a higher incidence of age-related diseases, thereby increasing the need for advanced drug delivery solutions.
• Healthcare Infrastructure: Well-established healthcare infrastructure and a high level of medical expertise in Europe are conducive to the adoption of advanced drug delivery systems.
• Government Initiatives: Supportive government policies and funding for medical research are accelerating the development and implementation of IGDD technologies.

Market Challenges

• High Costs: The initial investment and maintenance costs of IGDD systems can be prohibitive, limiting their accessibility, especially in smaller healthcare facilities.
• Regulatory Hurdles: Navigating the complex regulatory landscape for medical devices and drug delivery systems can delay market entry and adoption.
• Technical Limitations: Challenges related to the integration of imaging and drug delivery technologies, as well as issues with device calibration and standardization, can impact the effectiveness of IGDD systems.
• Patient Awareness: Limited patient awareness and understanding of IGDD therapies can hinder acceptance and utilization of these advanced treatment options.
• Data Privacy Concerns: The use of imaging data in drug delivery raises concerns regarding patient data privacy and security, necessitating stringent compliance with data protection regulations.

Key Market Players and Competition Synopsis

• Renishaw plc.
• Neurochase
• Koninklijke Philips N.V.

Market Segmentation

By Technology Type

• Drug-Delivery Systems
• Image-Guided Platforms

By Application

• Oncology
• Neurology
• Others

By End User

• Hospitals
• Pharmaceutical & Biotechnology Companies
• Contract Research Organizations (CROs)
• Research Institutes & Universities

By Region

• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Rest-of-Europe

Key Attributes:

For more information about this report visit https://www.researchandmarkets.com/r/1h7ecm

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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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Cell & Gene Therapies in Respiratory Disorders Therapeutic Analysis Report 2025: Landscape is Currently in the Early Stages of Development, with No Marketed CGTs to Date. – ResearchAndMarkets.com




Cell & Gene Therapies in Respiratory Disorders Therapeutic Analysis Report 2025: Landscape is Currently in the Early Stages of Development, with No Marketed CGTs to Date. – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Cell & Gene Therapies in Respiratory Disorders: Therapeutic Analysis” report has been added to ResearchAndMarkets.com’s offering.

The cell and gene therapies (CGTs) landscape for respiratory diseases is currently in the early stages of development, with no marketed CGTs to date.

Reasons to Buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
• Develop business strategies by understanding the trends shaping and driving the CGT in Respiratory market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact Respiratory disease targeting CGT therapeutics market in the future.
• Identify emerging players with potentially strong product portfolios and create effective counterstrategies to gain a competitive advantage.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Key Topics Covered:

1. Preface

1.1. Contents

1.2. Abbreviations

1.3. Related Reports

2. Executive Summary

3. Introduction and Scope

4. Current Treatment Options

4.1. What is Cell & Gene Therapy?

4.2. History of the Development of CGT in Respiratory Disorders

5. Unmet Needs

5.1. Challenges and Opportunities in CGT in Respiratory Disorders

6. Regulations

6.1. Regulation of CGTs in the 8MM

7. Future Market Assessment

7.1. Top 20 Respiratory Disorders with CGT Development

7.2. Top Five Respiratory Disorders with the Most CGT Pipeline Assets

7.3. Top Five Respiratory Disorders Stratified by Molecule Type

7.4. CGT in Respiratory Disorders -Phase II/III

7.5. Industry Trends in the Application of CGTs in Respiratory Disorders

7.6. CGT Market Catalyst are limited to a single company in the next 5 years

8. Likelihood of Approval and Phase – Transition Success Rate Analysis

8.1. CGT Candidates Have Lower PTSR vs. Indication Benchmarks

9. Sales Forecast

9.1. Sales are forecast to reach $62 million by 2030

10. Appendix

Companies Featured

• Vertex Pharmaceuticals Inc
• MediPost Co Ltd
• KYORIN Pharmaceuticals Co Ltd
• Bonus BioGroup Ltd
• Armata Pharmaceuticals Ltd
• Translate Bio Inc
• 4D Molecular Therapeutics Inc
• Suzhou Regend Therapeutics Co Ltd
• MiNK Therapeutics Inc
• Human Life CORD Japan Inc
• Nuwacell Biotechnology Co Ltd
• Taskin Bioregeneration Co

For more information about this report visit https://www.researchandmarkets.com/r/f94g3w

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

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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

Bipolar Disorder Market Opportunity Assessment and Forecast Report 2024-2034: Addressing Treatment Gaps in Bipolar Depression, Early Diagnosis, Patient Adherence, and Clinical Trial Effectiveness – ResearchAndMarkets.com




Bipolar Disorder Market Opportunity Assessment and Forecast Report 2024-2034: Addressing Treatment Gaps in Bipolar Depression, Early Diagnosis, Patient Adherence, and Clinical Trial Effectiveness – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Bipolar Disorder: Opportunity Assessment and Forecast” report has been added to ResearchAndMarkets.com’s offering.

This report covers the 7MM and provides an Excel-based forecast model for the Bipolar Disorder market through 2034.

The bipolar disorder market is crowded with inexpensive generic products and off-label drugs. There are currently not many effective treatments targeting bipolar depression, warranting targeted drug development. In the late-stage pipeline (Phase IIb onwards), there are four products being developed to target the depressive polarity of bipolar disorder.

The BD market across the 7MM was valued at $5.6 billion in the 2024 baseline year. Over the 10- year forecast period, the market is projected to grow at a compound annual growth rate (CAGR) of 5.3%, reaching $9.4 billion by 2034. The entry of the six pipeline products during the forecast period will have a significant impact on the market. They are anticipated to contribute $2.8 billion in sales by 2034.

Report Scope

• Overview of Bipolar Disorder (BD) market, including epidemiology, symptoms, diagnosis, and disease management.
• Annualized BD therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2024 to 2034.
• Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the BD market.
• Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for BD. The most promising candidates in late-stage development are profiled.
• Analysis of the current and future market competition in the 7MM BD therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
• Develop business strategies by understanding the trends shaping and driving the 7MM BD therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the BD therapeutics market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Key Topics Covered:

1. Preface

1.1. Contents

1.2. Abbreviations

1.3. Related Reports

2. Executive Summary

3. Disease Overview

3.1. Overview of Bipolar Disorder (BD)

3.2. Pathophysiology of Bipolar Disorder (BD)

3.3. Classification of Bipolar Disorder (BD)

3.4. Bipolar Disorder SWOT Analysis

4. Epidemiology

4.1. Lifetime Total Prevalent Cases of BD (I and II), Both Sexes, All Ages =12 Years, 2024-34

4.2. Lifetime Diagnosed Prevalent Cases of BD (I and II), Both Sexes, All Ages =12 Years, 2024-34

4.3. Sex-Specific Lifetime Total Prevalent Cases of BD (I and II), All Ages =12 Years, 2024

4.4. Sex-Specific Lifetime Diagnosed Prevalent Cases of BD (I and II), All Ages =12 Years, 2024

4.5. Age-Specific Trends in Lifetime Total Prevalent Cases of BD (I and II), Both Sexes, 2024

4.6. Age-Specific Trends in Lifetime Diagnosed Prevalent Cases of BD (I and II), Both Sexes, 2024

4.7. Lifetime Total Prevalent Cases of BD by Subtype, Both Sexes, All Ages =12 Years, 2024

4.8. Lifetime Diagnosed Prevalent Cases of BD by Subtype, Both Sexes, All Ages =12 Years, 2024

4.9. Sources and Methodology for the Lifetime Total Prevalence of BD I and BD II in Adolescents

4.10. Sources and Methodology for the Lifetime Total Prevalence of BD I and BD II in Adults

4.11. Sources and Methodology for the Lifetime Diagnosed Prevalence of BD I and BD II in Adolescents

4.12. Sources and Methodology for the Lifetime Diagnosed Prevalence of BD I and BD II in Adults

4.13. Sources and Methodology – Lifetime Total Prevalent Cases of BD in Adolescents

4.14. Sources and Methodology – Lifetime Total Prevalent Cases of BD in Adults

4.15. Sources and Methodology – Lifetime Diagnosed Prevalent Cases of BD

5. Current Treatment Options

5.1. Treatment Paradigm

5.2. Treatment Paradigm – Bipolar I

5.3. Treatment Paradigm – Bipolar II

5.4. Current Treatment Options

5.5. Product Profile: Anticonvulsants (e.g., lithium, carbamazepine, lamotrigine, valproate)

5.6. Product Profile: Loxapine (e.g., Adasuve)

5.7. Product Profile: Aripiprazole (e.g., Abilify)

5.8. Product Profile: LAI antipsychotics (e.g., Abilify Maintena, Risperdal Consta, Rykindo)

5.9. Product Profile: Zipradisone (e.g. Geodon/Zeldox)

5.10. Product Profile Lurasidone (Latuda)

5.11. Product Profile: Quetiapine (e.g. Seroquel, Seroquel XR)

5.12. Product Profile: Risperidone (e.g. Risperdal)

5.13. Product Profile: Other atypical antipsychotics (e.g., asenapine, olanzapine)

5.14. Product Profile: Cariprazine (e.g., Vraylar, Reagila)

5.15. Product Profile: Lybalvi (olanzapine + samidorphan)

5.16. Product Profile: Caplyta (lumateperone)

5.17. Product Profile: Fanapt (Iloperidone)

5.18. Product Profile: Igalmi (dexmedetomidine)

6. Unmet Needs and Opportunities

6.1. Unmet Needs in Bipolar Disorder

6.2. Lack of Effective Treatments for Bipolar Depression

6.3. Measures to Improve Earlier Diagnosis Rates and Patient Compliance

6.4. More Effective Clinical Trials

7. R&D Strategies

7.1. Trends in Clinical Trial Design in BD

7.2. Trends in Deal-Making in BD

8. Pipeline Assessment

8.1. Bipolar Disorder (BD) Pipeline Overview

8.2. Late-Stage Pipeline Agents for Bipolar Disorder (BD)

8.3. Product Profile: Jina Pharmaceutical’s endoxifen

8.4. Product Profile: Bristol Myers-Squibb’s Cobenfy (trospium chloride + xanomeline)

8.5. Product Profile: Vanda Pharmaceutical’s Bysanti (milsaperidone)

8.6. Product Profile: NRX Pharmaceutical’s Cyclurad (cycloserine + lurasidone) and NRX-100

8.7. Product Profile: Xenon Pharmaceutical’s azetukalner

8.8. Bipolar Disorder (BD): Clinical Trials (Phase II/III) Overview

9. Market Outlook

9.1. Bipolar Disorder (BD) Market Forecast

9.2. Market Drivers and Barriers

10. Appendix

10.1. Diagnostic criteria for a manic episode

10.2. Diagnostic criteria for a hypomanic episode

10.3. Diagnostic criteria for a major depressive episode

10.4. Primary Research: KOL Information

10.5. Bibliography

10.6. About the Authors

For more information about this report visit https://www.researchandmarkets.com/r/w7q9nk

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

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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

Insomnia Market Opportunity Assessment and Forecast Report 2022-2032: Z-Drugs Remain First-Line as Sparse Pipeline Adds $288 Million From Late-Stage Entrants – ResearchAndMarkets.com




Insomnia Market Opportunity Assessment and Forecast Report 2022-2032: Z-Drugs Remain First-Line as Sparse Pipeline Adds $288 Million From Late-Stage Entrants – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Insomnia: Opportunity Assessment and Forecast Update” report has been added to ResearchAndMarkets.com’s offering.

This report covers the 7MM and provides an Excel-based forecast model for the Insomnia market through 2032.

Z-drugs are the most common first-line treatment for insomnia across the US and 5EU. The insomnia pipeline in the 7MM is sparse but varied, containing products with varying mechanisms of action. There are five pipeline products in Phase II and III stages of clinical development for insomnia. The insomnia market across the 7MM was valued at $3.1 billion in the 2022 baseline year.

Over the 10- year forecast period, the market is projected to grow at a compound annual growth rate (CAGR) of 2.1%, reaching $3.8 billion by 2032. The entry of the two pipeline products during the forecast period will have a significant impact on the market. They are anticipated to contribute $288 million in sales by 2032.

Report Scope

• Overview of insomnia market, including epidemiology, symptoms, diagnosis, and disease management.
• Annualized insomnia therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2022 to 2032.
• Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the insomnia market.
• Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for insomnia. The most promising candidates in late-stage development are profiled.
• Analysis of the current and future market competition in the 7MM insomnia therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
• Develop business strategies by understanding the trends shaping and driving the 7MM insomnia therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the insomnia therapeutics market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Key Topics Covered:

1. Preface

1.1. Contents

1.2. Abbreviations

1.3. Related Reports

2. Executive Summary

2.1. Summary of Updates

3. Disease Overview

3.1. Overview of Insomnia

3.2. Insomnia SWOT Analysis

3.3. Pathophysiology of Insomnia

3.4. Classification of Insomnia

4. Epidemiology

4.1. Total Prevalent Cases of Insomnia, Both Sexes, Ages 15 Years, 2022-32

4.2. Age-Specific Trends in the Total Prevalent Cases of Insomnia, Both Sexes, 2022

4.3. Sex-Specific Total Prevalent Cases of Insomnia, Both Sexes, Ages 15 Years, 2022

4.4. Sex-Specific Total Prevalent Cases of Acute Insomnia, Ages 15 Years, 2022

4.5. Sex-Specific Total Prevalent Cases of Chronic Insomnia, Ages 15 Years, 2022

4.6. Sources and Methodology for Acute and Chronic Insomnia Prevalence

4.7. Sources and Methodology – Total Prevalent Cases of Acute and Chronic Insomnia

5. Current Treatment Options

5.1. Treatment Paradigm

5.2. Current Treatment Options

5.3. Product Profile: Benzodiazepines (e.g., estazolam, temazepam, flurazepam)

5.4. Product Profile: Z-Drugs (zaleplon, zolpidem, zopiclone, eszopiclone)

5.5. Product Profile: Melatonin Receptor Agonists (ramelteon and melatonin ER)

5.6. Product Profile: Low-Dose Antidepressants (doxepin, trazodone, trimipramine)

5.7. Product Profile: Antihistamines (e.g., diphenhydramine, promethazine, hydroxyzine)

5.8. Product Profile: Gabapentinoids (e.g., gabapentin and pregabalin)

5.9. Product Profile: Merck & Co’s Belsomra (suvorexant)

5.10. Product Profile: Eisai’s Dayvigo (lemborexant)

5.11. Product Profile: Idorsia’s Quviviq (daridorexant)

5.12. Product Profile: Taisho Pharmaceutical’s Borzi (vornorexant)

5.13. Patient Flow: Insomnia in 2022 Across 7MM

6. Unmet Needs and Opportunities

6.1. Unmet Needs in Insomnia

6.2. New Therapeutic Options with Improved Efficacy

6.3. Improved Physician Awareness of Insomnia Treatments

6.4. Improved Patient Access to CBT-i

7. R&D Strategies

7.1. Trends in Clinical Trial Design in Insomnia

7.2. Trends in Deal-Making in Insomnia

8. Pipeline Assessment

8.1. Insomnia Pipeline Overview

8.2. Late-Stage Pipeline Agents for Insomnia

8.3. Product Profile: EUSOL Biotech’s SM-1

8.4. Product Profile: Imbrium Therapeutics’s Sunobinop

8.5. Product Profile: Vanda Pharmaceuticals’s Hetlioz (tasimelteon)

8.6. Insomnia: Clinical Trials (Phase II/III) Overview

9. Market Outlook

9.1. Insomnia Market Forecast

9.2. Market Drivers and Barriers

10. Appendix

10.1. Primary Research: KOL Information

10.2. Primary Research: High-Prescriber Survey Information

10.3. Bibliography

10.4. About the Authors

Companies Featured

• Merck & Co Inc
• Viatris Inc
• Sumitomo Pharma Co Ltd
• Takeda Pharmaceutical Co Ltd
• Neurim Pharmaceuticals Ltd
• Vanda Pharmaceuticals Inc
• Sanofi
• Taisho Pharmaceutical Holdings Co Ltd
• Idorsia Pharmaceutical Ltd
• EUSOL Biotech Co Ltd
• Imbrium Therapeutics LP
• Currax Holdings USA LLC

For more information about this report visit https://www.researchandmarkets.com/r/dns27p

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

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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

Cybin Initiates At-The-Market Equity Program of up to US$100 Million




Cybin Initiates At-The-Market Equity Program of up to US$100 Million

TORONTO–(BUSINESS WIRE)–Cybin Inc. (NYSE American:CYBN) (Cboe Canada CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative next-generation treatment options, today announced that it has launched an at-the-market equity program (the “ATM Program”) to allow Cybin to issue and sell up to US$100,000,000 of common shares in the capital of the Company (the “Shares”) from treasury to the public, from time to time, through Cantor Fitzgerald and Co. and Cantor Fitzgerald Canada Corporation (together the “Agents”).

All the Shares sold under the ATM Program will be sold in transactions that are deemed to be “at-the-market offerings” under Rule 415 of the U.S. Securities Act of 1933, as amended, and “at-the-market” distributions as defined in National Instrument 44-102 – Shelf Distributions, directly through Cboe Canada Inc. (“Cboe Canada”), a United States stock exchange or any other “marketplace” (as defined in National Instrument 21- 101 – Marketplace Operation) upon which the Shares are listed, quoted or otherwise traded, at the prevailing market price at the time of sale. Cybin intends to use the net proceeds from sales of the Shares under the ATM Program, if any, for growth opportunities and working capital initiatives.

Distributions of the Shares under the ATM Program, if any, will be made pursuant to the terms and conditions of an “at-the-market” equity distribution agreement (the “Distribution Agreement”) dated December 30, 2025, entered into by and among the Company and the Agents. A copy of the Distribution Agreement can be found under the Company’s profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov/edgar.

Unless earlier terminated in accordance with the terms of the Distribution Agreement, the ATM Program will be effective until the earlier of the issuance and sale of all of the Shares issuable pursuant to the ATM Program and October 17, 2027. The Company is not obligated to make any sales of Shares under the ATM Program and there can be no assurance as to when such sales will be completed, if ever. The volume and timing of distributions under the ATM Program, if any, will be determined in Cybin’s sole discretion and in accordance with the Distribution Agreement. As any Shares distributed under the ATM Program will be issued and sold at the prevailing market price at the time of sale, prices may vary among purchasers through the duration of the ATM Program. The completion of sales of the Shares under the ATM Program will be subject to customary closing conditions, including the listing of such Shares on Cboe Canada and any United States stock exchange on which the Shares may be listed, and any required approvals of any such exchanges.

The ATM Program is being established, and the sale of the Shares through the ATM Program will be made pursuant to, and qualified by way of a prospectus supplement dated December 30, 2025 (the “Prospectus Supplement”) to the Company’s short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025 (the “Base Shelf Prospectus”) filed with the securities commissions in each of the provinces and territories of Canada. The Base Shelf Prospectus allows Cybin to qualify offerings of Shares, warrants, subscription receipts, units or debt securities, or a combination thereof, up to an aggregate total of C$1,700,000,000 during the 25-month period, ending on October 17, 2027, that the Base Shelf Prospectus remains effective. The Prospectus Supplement will be filed with the United States Securities and Exchange Commission as a supplement to the Company’s registration statement on Form F-10 (File No. 333-292294), which became effective on December 19, 2025, in accordance with the Multijurisdictional Disclosure System established between Canada and the United States.

The Prospectus Supplement and accompanying Base Shelf Prospectus contain important detailed information about the ATM Program. The Prospectus Supplement and accompanying Base Shelf Prospectus can be found under the Company’s profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov/edgar. Copies of the Prospectus Supplement and accompanying Base Shelf Prospectus may also be obtained from Cantor Fitzgerald Canada Corporation, Attn: Equity Capital Markets, 181 University Avenue, Suite 1500, Toronto, ON, M5H 3M7, Email: ecmcanada@cantor.com, Cantor Fitzgerald & Co., Attn: Capital Markets, 110 East 59th Street, 6th floor, New York, New York 10022, Email: prospectus@cantor.com. Prospective investors should read the Prospectus Supplement and accompanying Base Shelf Prospectus and the other documents the Company has filed before making an investment decision.

This news release does not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor will there be any sale of the Shares, in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

About Cybin

Cybin is a breakthrough Phase 3 clinical-stage neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.

With promising class leading data, Cybin is working to change the mental health treatment landscape through the introduction of novel drugs that provide effective and durable results for patients. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds.

Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, and Ireland. For Company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, “forward-looking statements”) and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “potential”, “possible”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the sale of the Shares from time to time under the ATM Program; the Company’s intended use of the net proceeds from sales of the Shares, if any, under the ATM Program; the receipt of applicable regulatory approvals, including the acceptance of Cboe Canada, the listing and posting of the Shares on the Nasdaq Global Market, and the Company’s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company’s operations; and the risk factors set out in each of the Company’s management’s discussion and analysis for the three and six months ended September 30, 2025, and the Company’s annual information form for the year ended March 31, 2025, which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca and on the Company’s profile on EDGAR at www.sec.gov/edgar. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither Cboe Canada, nor NYSE American have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Contacts

Investor Contact:
Josh Barer

astr partners

Managing Director

(908) 578-6478

josh.barer@astrpartners.com

Media Contact:
George Tziras

Chief Business Officer

Cybin Inc.

1-866-292-4601

irteam@cybin.com – or – media@cybin.com

Advanced Pharmacovigilance Training Course: Performing Successful Due Diligence to Benefit-Risk Assessments and What to Consider (Online Event: Mar 23rd – Mar 25th, 2026) – ResearchAndMarkets.com




Advanced Pharmacovigilance Training Course: Performing Successful Due Diligence to Benefit-Risk Assessments and What to Consider (Online Event: Mar 23rd – Mar 25th, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Advanced Pharmacovigilance: From Performing Successful Due Diligence to Benefit-Risk Assessments – What to Consider Training Course (Mar 23rd – Mar 25th, 2026)” training has been added to ResearchAndMarkets.com’s offering.

This course is designed for those with at least two years’ knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company. Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex range of safety and risk assessment activities to perform.

Who Should Attend:

This course would be of maximum benefit to those safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing. The course covers very diverse activities within the safety department and would be advantageous to those who have either multifunction responsibilities or medical directors who manage teams in the various disciplines.

Key topics to be addressed:

• Audits and expectations – risk-based inspections
• Compliance and drug safety
• Overview of the PSMF in the EU
• Product safety reviews – purpose and function (incorporating the latest EU signal analysis requirements)
• Safety reporting in licensing agreements
• Developing company core safety information (CCSI) – CIOMS III
• PSURs – timing, content and the DSUR and the latest ICH E2C (2nd revision requirements)
• Implications for safety reporting in global clinical trials
• Risk-benefit determinations
• Risk management plans (RMPs)

Benefits of attending

• Expand your global safety knowledge
• Enhance your team’s capabilities and compliance in both the regulations and your company’s expectations
• Help ensure you build and maintain a quality pharmacovigilance department ready for any pharmacovigilance inspection
• Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspections

Certifications:

• CPD: 18 hours for your records
• Certificate of completion

Key Topics Covered:

Due diligence

• Due diligence on products/companies (partners and acquisitions)
• Due diligence involvement – team composition
• Safety information requirements for due diligence
• Review of safety data (clinical and post-marketing)
• Defining risk in due diligence appraisals

Training for drug safety reporting duties

• Regulations concerning safety training
• Who trains whom and when?
• Training versus job description
• Training records, maintenance and updates
• Role of QA and HR in training

Audits and expectations

• Regulatory expectations in pharmacovigilance audits (risk-based inspections)
• Preparation for the audit
• Records to be available at the audit
• Audit findings/recommendations

Compliance and drug safety

• Basic principles – what will the regulators want to see?
• Measuring compliance
• Quality versus quantity in safety reports
• Future aspects in ensuring efficient compliance
• Quality management under the new EU legislation

The PSMF

• The PSMF – purpose and maintenance
• The PSMF annexes
• The PSMF and audits

Interactive exercise: The requirements for a safety department

Product safety reviews – purpose and function

• The Safety Review Committee (SRC)
• What to look for in signal evaluation under latest EU guidance
• Timings for safety review in clinical and post-marketed products
• Record keeping for safety review meetings
• Serious safety findings – crisis management following new safety findings

Interactive exercise: designing the requirements for a safety review group

Safety reporting in licensing agreements

• What types of licensing agreements exist?
• What are the EU and FDA regulations concerning licensing agreements?
• Audits of pharmacovigilance capabilities in licensing partners
• What agreements need to be in place for safety reporting?
• Safety reporting agreements – what needs to be covered?
• Monitoring safety agreements – what happens if it goes wrong?

Developing CCSI – CIOMS III

• CIOMS III and CCSI
• Developmental core safety information (DCSI)
• How to determine what to include and what to exclude in DCSI/CCSI
• Are there differences in EU and FDA?
• Maintenance and development of CCSI

Interactive exercise: should new safety data from a clinical trial be put into core safety information?

PSURs and the revisions in ICH E2C

• Timing for PSURs
• PSUR content and latest format
• Late breaking information and PSUR extensions
• The DSUR

The EU Clinical Trials Directive

• The principles of the Directive
• Implications for safety reporting in global clinical trials
• The SUSAR database
• The EUDRACT database
• The new EU clinical trial regulation

Risk-benefit determinations

• Definitions of risk-benefit – FDA and EU perspective
• Risk-benefit assessments – who does this and where does the information go?
• Safety assessments and risk-benefit – frequency and reporting
• Changes in risk-benefit – how to manage and review existing profiles

Risk-benefit determinations

• Definitions of risk-benefit – FDA and EU perspective
• Risk-benefit assessments – who does this and where does the information go?
• Safety assessments and risk-benefit – frequency and reporting
• Changes in risk-benefit – how to manage and review existing profiles

Interactive exercise: reviewing the safety and risk-benefit of a product

RMPs

• Purpose
• Content
• Monitoring and updating the RMP
• Reporting the RMP

Crisis management within drug safety

• Regulations and guidelines in connection with serious safety issues
• What determines a crisis?
• Communications to regulators – what is required?
• Communications within the company
• What happens next?

Interactive exercise: deciding how to handle a major crisis within the company

• Delegates will be split into groups and present what they need to have in place in order to effectively manage the crisis and look to its resolution.

Speakers:

Graeme Ladds

Director

PharSafer Associates Ltd.

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

For more information about this training visit https://www.researchandmarkets.com/r/v06j3e

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

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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

European Union Pharmaceutical Regulations & Strategy Training Course: Legal Frameworks, Pre-Submission Strategy, Data Presentation, and Post-Approval Obligations (Online Event: Mar 2nd – 3rd, 2026) – ResearchAndMarkets.com




European Union Pharmaceutical Regulations & Strategy Training Course: Legal Frameworks, Pre-Submission Strategy, Data Presentation, and Post-Approval Obligations (Online Event: Mar 2nd – 3rd, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “EU (European Union) Pharmaceutical Regulations & Strategy Training Course (Mar 2nd – Mar 3rd, 2026)” training has been added to ResearchAndMarkets.com’s offering.

This interactive course will provide an overview of the current European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation. The proposed EU pharmaceuticals legislation changes will be discussed in the relevant sections.

In the highly regulated field of pharmaceuticals, staying abreast of regulatory affairs is crucial for ensuring compliance, maintaining market authorisations, and effectively managing drug development and post-approval obligations. Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging. This is where a comprehensive understanding of pharmaceutical regulatory affairs becomes indispensable.

Creating and coordinating an effective regulatory strategy is an essential part of the work of a regulatory affairs department and can save valuable time and money. It is therefore important to be aware of potential changes which may impact on strategy.

The programme will cover the legal basis of regulation, development strategies and the importance of pre-submission activities as well a brief overview of the format for presentation of data, the registration procedures for obtaining marketing authorisations and post-authorisation obligations and strategic considerations.

The UK is no longer part of the EU but knowledge of interactions and collaboration with the EU and other regulatory agencies are important for obtaining and maintaining marketing authorisations in the UK. Case study sessions will explore options and strategies for key regulatory activities and provide an opportunity for discussion and the sharing of experiences with our expert trainer and other delegates.

Benefits of attending

• Understand the legal basis of the current EU regulatory environment
• Outline the background to and the proposed EU pharmaceutical legislation changes
• Discuss development strategy and pre-submission activities
• Review procedures for applying for a marketing authorisation in the EU/EEA and in the UK
• Discuss post-authorisation strategic considerations and obligations

Who Should Attend:

The course is designed primarily for regulatory affairs personnel, however it will also be of value to those who interact with the regulatory affairs function and would benefit from an understanding of action timelines and information requirements. It will be particularly relevant to all those working in:

• Regulatory affairs
• Project management
• Business planning
• Commercial management
• Manufacturing and QA
• Labelling and artwork
• Medical information
• Clinical
• Pharmacovigilance

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

Key Topics Covered:

Day 1

EU regulatory environment: legal basis

• Key regulations, directives and guidelines
• Proposed EU pharmaceuticals legislation changes Information sources

Information sources

Case Study One

Development and Strategy

• Drug discovery
• Scientific advice

Development process

• Pharmaceutical R&D
• Non-clinical tests
• Clinical studies – Phase I to III

EU Clinical Trials Regulation

Types and categories of marketing Authorisations

Adaptive marketing authorisation procedures

The Common Technical Document (CTD)

• Overview of Structure and content of a CTD

Procedures for obtaining a marketing authorisation in the EU and EMA

• The EU centralised procedure

Other EU centralised procedures

• Referral and arbitration

Day 2

Other procedures for obtaining a marketing authorisation in the EU

• Coordination group
• Decentralised procedure (DCP)
• Mutual recognition procedure (MRP)
• National procedures

Managing product labelling

Case Study Two

Abridged applications and Generics

• Types and Requirements

Product Life Cycle; Post approval

Patents and SPCs

Parallel trade

Post-authorisation obligations; pharmacovigilance, variations and renewals

Pharmacovigilance

Licence variations

• Type I and Type II variations and timelines
• Procedures and timelines

Extensions

Case Study Three

Renewals

Sunset clause

Phase IV Trials

Classification change

Generic development

Strategic factors

Criteria for successful products

Speakers:

Norah Lightowler

Lightowler Associates

Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twentieth year of successful business. Norah has wide experience in the pharmaceutical and related neutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.

For more information about this training visit https://www.researchandmarkets.com/r/teu577

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

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course (Online Event: Mar 5th – Mar 6th, 2026) – ResearchAndMarkets.com




Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course (Online Event: Mar 5th – Mar 6th, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course (Mar 5th – Mar 6th, 2026)” training has been added to ResearchAndMarkets.com’s offering.

This interactive course will guide you through national procedures as well as explore the implications of and updates on the Eurasian Union regulation.

The pharmaceutical markets in Russia, the Eurasian Union and the CIS are of growing commercial importance and companies looking to take advantage of the opportunities available need to be fully up to date with the evolving regulatory landscape for human pharmaceuticals, including the potential for market access offered by the latest legislation.

The focus of the programme is to offer practical advice in developing your regulatory strategy for product approval in these countries and you will get the full benefit of our trainer’s experience and expertise in the region.

Benefits of attending:

• Understand the competitive landscape of the growing markets in the CIS region
• Discover the essential information on the latest regulations and registration procedures in the Eurasian Customs Union
• Discuss national requirements and guidance for drug approval in the core CIS markets of Russia, Kazakhstan, Belarus, Ukraine and Azerbaijan
• Develop your CIS regional submission plan and place it within your global regulatory strategy
• Gain practical advice from an industry expert working in the CIS region

Why you should attend

Attending this programme will:

• Give you the full background to the CIS pharmaceutical market
• Ensure that you understand all the implications of the latest regulations which will affect how you do business in the Eurasian Economic Union (EAEU)
• Help clarify the document requirements and timelines of national procedures and EAEU registration procedures
• Update you on the national regulations in Russia, Belarus, Kazakhstan, Ukraine and other CIS countries

Who Should Attend:

This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and regulatory compliance in this region. The seminar will be useful either as an introductory or refresher course.

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

Key Topics Covered:

Day 1

CIS – regional regulatory overview

• CIS and Russia Market Overview
• Market protection policies
• CIS and Russia in regional and international Regulatory Harmonisation

Common regional requirements in CIS

• Administrative data, translations, normative documents, samples, labelling, etc

Eurasian economic area

• Countries current members of EAEU and EAEU Official bodies
• History of EUAE, scope of products, available experience
• Terms of transition period for medicines

Eurasian Regulations for Medicines

• Overview of EAEU regulatory framework
• Registration Procedures and Application Process
• EAEU submission documents and data requirements
• GMP inspections
• PhV requirements

Day 2

Registration of Medicine in Russia

• Regulatory authorities in Russia
• Key regulations governing the registration process
• Clinical trials

National Regulatory Procedures in Russia

• Application dossier and data requirements
• Post approval life cycle maintenance applications
• Safety reporting and market surveillance
• Price and reimbursement
• Patent data protection

Registration in other EAEU countries

• Kazakhstan, Belarus, Armenia, Kirgizstan

Registration in other CIS countries

• EU sphere of influence: Ukraine, Moldova, Georgia
• National procedures: Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan

Workshop – CIS Regional Regulatory Strategy

Speakers:

Anna Harrington-Morozova

Scientific and Regulatory Director

Regem Consulting Ltd

Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years’ experience gained in regulatory authority, academia, clinical and industry environment. Anna graduated in Russia as a pharmacist. After working in the Russian Ministry of Health and the Clinical Pharmacology Department of Moscow Medical University Anna held regulatory and external relation positions in the pharmaceutical industry and CROs in Russia and the UK, including senior regulatory affairs posts in GSK, EISAI, ICON and PRA. Anna currently acts as a Scientific and Regulatory Director at Regem Consulting Ltd – a regulatory and drug development consultancy with a focus on global regulatory and drug development strategies, advocacy and registrations in emerging markets.

For more information about this training visit https://www.researchandmarkets.com/r/rthrb0

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

Laura Wood, Senior Press Manager

press@researchandmarkets.com
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