Home > News > featured news > Treosulfan, a First-In-Class Conditioning Agent, is Licensed in Canada by Medexus Pharmaceuticals and Medac GmbH

PHARMACY MARKET

Treosulfan, a First-In-Class Conditioning Agent, is Licensed in Canada by Medexus Pharmaceuticals and Medac GmbH

Medexus Pharmaceuticals | July 13, 2021

Medexus Pharmaceuticals Inc. announced today that it has entered into a licensing deal with medac GmbH to commercialize treosulfan, a bifunctional alkylating agent, in Canada.

Treosulfan will be sold in Canada as Trecondyv and will be used in conjunction with fludarabine as part of a conditioning regime before allogeneic hematopoietic stem cell transplantation. Medexus will be in charge of selling and promoting the product, while Medac will manufacture and supply it.

Medexus has been distributing treosulfan in Canada through the Special Access Program, and Health Canada recently approved Trecondyv for the treatment of adult patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes who are at increased risk for standard conditioning therapies, as well as pediatric patients older than one year with AML or MDS.

About medac GmbH

medac GmbH is a privately owned global pharmaceutical firm that is expanding its pharmaceutical and diagnostics businesses. Since its inception in Germany in 1970, medac has specialized in treating diseases related to oncology, hematology, urology, and auto-immune disorders. medac is dedicated to improving current therapeutic products and creating new ones to enhance patients' quality of life. In addition, medac has earned a reputation for developing novel medicines in less common indications. This dedication has resulted in a diverse range of pharmaceutical goods that positively impact the lives of patients. medac is constantly investing in product development and manufacturing and logistical capacities to fulfill the requirements of both patients and healthcare professionals.

About Medexus
Medexus is a market leader in novel rare disease treatment solutions, with a solid commercial platform in North America. We are building a highly distinctive business with a portfolio of innovative and high-value orphan and rare disease medicines that will support our growth for the next decade, based on a foundation of proven best-in-class medications. Through our key principles of Quality, Innovation, Customer Service, and Teamwork, the Company's goal is to offer the finest healthcare products to healthcare professionals and patients. Medexus Pharmaceuticals specializes in the treatment of auto-immune illness, hematological, and allergies. Rasuvo and Metoject, a unique methotrexate formulation (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; IXINITY, an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B – a hereditary bleeding disorder characterized by a deficiency of clotting factor

Spotlight

Understand Market Access Trends in the US, Europe and Emerging Markets

Rising drug spending and increased desire for expenditure controls are consistent themes across the US, Europe, and emerging markets. With governments and private healthcare systems under increasing pressure to fund high-cost, innovative therapies, which often launch with limited clinical trial evidence, payers are looking towards new and enhanced reimbursement processes which align drug funding with patient value. Based on these growing demands, the healthcare policy environment remains fluid, with payers introducing increasingly restrictive cost-control mechanisms in order to limit the burden on constrained healthcare budgets. 

More featured news

Spotlight

Understand Market Access Trends in the US, Europe and Emerging Markets

Rising drug spending and increased desire for expenditure controls are consistent themes across the US, Europe, and emerging markets. With governments and private healthcare systems under increasing pressure to fund high-cost, innovative therapies, which often launch with limited clinical trial evidence, payers are looking towards new and enhanced reimbursement processes which align drug funding with patient value. Based on these growing demands, the healthcare policy environment remains fluid, with payers introducing increasingly restrictive cost-control mechanisms in order to limit the burden on constrained healthcare budgets. 

Related News

BUSINESS INSIGHTS

To Provide Suite of Clinical Trial Technologies and Services, Labcorp Renewed Strategic Partnership with Medidata

Medidata | April 01, 2022

A Dassault Systèmes company, Medidata, announced that Labcorp, a leading global life sciences company, has extended its 14-year partnership with Medidata, laying the groundwork for their initiative to co-develop digital biomarkers and expand the use and functionality of decentralized clinical trials. “Our relationship with Medidata is built on using their core technologies to enhance our clinical trial portfolio and continue to expand our decentralized clinical trial offerings. Our work to advance sensor and digital biomarker usage in clinical research can help accelerate patient care while providing valuable information to study sponsors.” Bill Hanlon, Ph.D., chief scientific officer and president of Clinical Therapeutic and Regulatory Sciences, Labcorp Drug Development Labcorp Drug Development's products are based on Medidata technology, including Rave EDC, Coder, and TSDV. In addition, Labcorp is currently using most of the Medidata Clinical Cloud platform, including eCOA, RTSM, and Imaging. “The last two years have required clinical trials to become more accessible and flexible; these changes make our strategic partnership with Labcorp Drug Development to modernize and decentralize trials even more critical,” said Anthony Costello, CEO Patient Cloud at Medidata. “With this new agreement, we’re excited to develop and deploy the innovations that help our customers run more effective clinical programs and get new treatments to patients faster than ever before.” Through its 3DEXPERIENCE platform, Medidata is positioned to lead the digital transformation of life sciences in the era of personalized medicine by providing the industry's first end-to-end scientific and business platform, from research to commercialization.

Read More

RESEARCH

eDeviation the Latest Protocol Deviations Cloud Software Solution

eDeviation | April 21, 2021

Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management. The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations. Protocol deviations (PD) are a recognized problem for clinical trials because they can jeopardize subjects' safety, rights, and welfare, as well as the study's data integrity, and thereby violate Good Clinical Practice standards. PDs must be established and submitted to the Institutional Review Board of clinical trials (IRB). They may also be classified as major or minor based on the effect on patient care and data integrity. Finally, corrective measures must be taken to ensure that the PDs do not reoccur, and all decisions and actions must be reported for GxP compliance. Clinical research teams face a significant administrative burden when it comes to managing and assessing PDs. In this context, a software platform that can support and document both PD assessment and management activities will significantly simplify the work of clinical research teams. "With eDeviation®, Ethical's portfolio of clinical research software solutions continues to expand to help our customers run their trials more efficiently and effectively," says Mimmo Garibbo, Director of Ethical GmbH. "In an era of increasingly complex clinical trials, we are pleased to have a solution that will assist sponsors, CROs, and EC/IRBs in minimizing the risk associated with protocol deviations." About Protocol Deviations A protocol deviation is any change, divergence, or departure from the approved protocol, consent agreement, recruitment process, or study materials (e.g., questionnaires) originally approved by the EC/IRB. The expression "protocol deviation" refers to protocol exceptions, modifications made to avoid immediate damage to subjects, and protocol violations. Protocol deviations may be classified as major or minor based on their effect on patient safety and data integrity. About eDeviation eDeviation® is a Protocol Deviations and Violations management cloud software designed to collect, manage and review protocol deviations in a simple, effective, and GxP-compliant way.

Read More

PHARMACY MARKET

Narrativa Raises $1.3M to Help Pharma Companies Accelerate the FDA Drug Approval Process

Narrativa | May 19, 2021

Narrativa, which has developed an artificial intelligence (AI) medical writing platform to assist pharmaceutical firms in speeding up drug approval and lowering overall compliance costs, recently completed a $1.3 million funding round. The Los Angeles-based firm currently uses its SaaS platform to automate the production of Clinical Study Reports (CSRs) and other regulatory reports for several pharmaceutical firms and other clinical research organizations (CROs). The AI-writing assistant platform utilizes advanced Natural Language Generation (NLG) to process millions of data points from clinical trials and generate readable and understandable written medical narratives, improving accuracy and minimizing the time and expense of producing critical (and time-consuming) regulatory documents. "The pharma industry has evolved as a result of the availability and quality of data from clinical trials, with the most significant impact on drug discovery. To detect trends, test hypotheses, and understand the effectiveness of treatments, pharmaceutical firms have often focused on empirical data. It's time to put artificial intelligence to work assisting medical authors in the development of regulatory documents "Narrativa's founder and CEO, David Llorente, says. Pharmaceutical firms spend more than $1.5 billion on regulatory documentation, and it may take up to a year to complete the paperwork for FDA approval of a new drug. The amount of time taken on regulatory documentation significantly lengthens the time it takes for new drugs to reach the market. About Narrativa Narrativa was established in 2015 with the idea that technology should be used to positively transform the world. Narrativa, named one of the most important companies in the field of NLG by Samsung, helps companies expand by anticipating trends and converting data into the human language in real-time. Narrativa creates automated content in a variety of areas, including finance, pharmaceuticals, insurance, media, and gaming, using its artificial intelligence system and machine learning experience.

Read More

BUSINESS INSIGHTS

To Provide Suite of Clinical Trial Technologies and Services, Labcorp Renewed Strategic Partnership with Medidata

Medidata | April 01, 2022

A Dassault Systèmes company, Medidata, announced that Labcorp, a leading global life sciences company, has extended its 14-year partnership with Medidata, laying the groundwork for their initiative to co-develop digital biomarkers and expand the use and functionality of decentralized clinical trials. “Our relationship with Medidata is built on using their core technologies to enhance our clinical trial portfolio and continue to expand our decentralized clinical trial offerings. Our work to advance sensor and digital biomarker usage in clinical research can help accelerate patient care while providing valuable information to study sponsors.” Bill Hanlon, Ph.D., chief scientific officer and president of Clinical Therapeutic and Regulatory Sciences, Labcorp Drug Development Labcorp Drug Development's products are based on Medidata technology, including Rave EDC, Coder, and TSDV. In addition, Labcorp is currently using most of the Medidata Clinical Cloud platform, including eCOA, RTSM, and Imaging. “The last two years have required clinical trials to become more accessible and flexible; these changes make our strategic partnership with Labcorp Drug Development to modernize and decentralize trials even more critical,” said Anthony Costello, CEO Patient Cloud at Medidata. “With this new agreement, we’re excited to develop and deploy the innovations that help our customers run more effective clinical programs and get new treatments to patients faster than ever before.” Through its 3DEXPERIENCE platform, Medidata is positioned to lead the digital transformation of life sciences in the era of personalized medicine by providing the industry's first end-to-end scientific and business platform, from research to commercialization.

Read More

RESEARCH

eDeviation the Latest Protocol Deviations Cloud Software Solution

eDeviation | April 21, 2021

Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management. The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations. Protocol deviations (PD) are a recognized problem for clinical trials because they can jeopardize subjects' safety, rights, and welfare, as well as the study's data integrity, and thereby violate Good Clinical Practice standards. PDs must be established and submitted to the Institutional Review Board of clinical trials (IRB). They may also be classified as major or minor based on the effect on patient care and data integrity. Finally, corrective measures must be taken to ensure that the PDs do not reoccur, and all decisions and actions must be reported for GxP compliance. Clinical research teams face a significant administrative burden when it comes to managing and assessing PDs. In this context, a software platform that can support and document both PD assessment and management activities will significantly simplify the work of clinical research teams. "With eDeviation®, Ethical's portfolio of clinical research software solutions continues to expand to help our customers run their trials more efficiently and effectively," says Mimmo Garibbo, Director of Ethical GmbH. "In an era of increasingly complex clinical trials, we are pleased to have a solution that will assist sponsors, CROs, and EC/IRBs in minimizing the risk associated with protocol deviations." About Protocol Deviations A protocol deviation is any change, divergence, or departure from the approved protocol, consent agreement, recruitment process, or study materials (e.g., questionnaires) originally approved by the EC/IRB. The expression "protocol deviation" refers to protocol exceptions, modifications made to avoid immediate damage to subjects, and protocol violations. Protocol deviations may be classified as major or minor based on their effect on patient safety and data integrity. About eDeviation eDeviation® is a Protocol Deviations and Violations management cloud software designed to collect, manage and review protocol deviations in a simple, effective, and GxP-compliant way.

Read More

PHARMACY MARKET

Narrativa Raises $1.3M to Help Pharma Companies Accelerate the FDA Drug Approval Process

Narrativa | May 19, 2021

Narrativa, which has developed an artificial intelligence (AI) medical writing platform to assist pharmaceutical firms in speeding up drug approval and lowering overall compliance costs, recently completed a $1.3 million funding round. The Los Angeles-based firm currently uses its SaaS platform to automate the production of Clinical Study Reports (CSRs) and other regulatory reports for several pharmaceutical firms and other clinical research organizations (CROs). The AI-writing assistant platform utilizes advanced Natural Language Generation (NLG) to process millions of data points from clinical trials and generate readable and understandable written medical narratives, improving accuracy and minimizing the time and expense of producing critical (and time-consuming) regulatory documents. "The pharma industry has evolved as a result of the availability and quality of data from clinical trials, with the most significant impact on drug discovery. To detect trends, test hypotheses, and understand the effectiveness of treatments, pharmaceutical firms have often focused on empirical data. It's time to put artificial intelligence to work assisting medical authors in the development of regulatory documents "Narrativa's founder and CEO, David Llorente, says. Pharmaceutical firms spend more than $1.5 billion on regulatory documentation, and it may take up to a year to complete the paperwork for FDA approval of a new drug. The amount of time taken on regulatory documentation significantly lengthens the time it takes for new drugs to reach the market. About Narrativa Narrativa was established in 2015 with the idea that technology should be used to positively transform the world. Narrativa, named one of the most important companies in the field of NLG by Samsung, helps companies expand by anticipating trends and converting data into the human language in real-time. Narrativa creates automated content in a variety of areas, including finance, pharmaceuticals, insurance, media, and gaming, using its artificial intelligence system and machine learning experience.

Read More

More featured news