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Business Insights, PHARMACY MARKET

Drug Development Technology Leader ArisGlobal Completes Acquisition of Amplexor Life Sciences

prnewswire | April 21, 2023 | Read time : 02:00 min

Drug Development Technology

ArisGlobal, the leading provider of life sciences software designed to automate core drug development functions with its end-to-end technology platform LifeSphere®, today announces the completion of its acquisition of Amplexor Life Sciences. This deal will deliver the most intelligent, connected, and comprehensive regulatory platform available, bringing increased efficiency for life sciences organizations as they bring new therapies to market.

A key development is the introduction of LifeSphere Quality Management, marking ArisGlobal's entry into the continuous quality improvement and risk management aspects of drug development.

LifeSphere Quality represents an expansion of ArisGlobal's interconnected drug development platform that spans the pharmaceutical product lifecycle including Clinical, Regulatory, Medical Affairs and Safety. Robust quality management system (QMS) capabilities, including automated workflows and analytics, are now available to support customers' global regulatory compliance needs.

The acquisition also rounds out the end-to-end LifeSphere Regulatory platform with the addition of a labeling management solution and accelerates the Regulatory product roadmap through the integration of enhanced global submission publishing capabilities.

ArisGlobal's intent to purchase was previously announced in late February 2023, and brings two new office locations in Croatia and Slovenia into ArisGlobal's geographic footprint.

About ArisGlobal

ArisGlobal is the creator of LifeSphere, a market leader in drug development technology solutions worldwide that is transforming the way today's most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States.

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Semi-automated testing of on-body delivery systems (OBDS)

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Spotlight

Semi-automated testing of on-body delivery systems (OBDS)

Injection systems that are attached to the patient's body (on-body delivery system OBDS) minimize possible risks, that can occur when drugs are administered by conventional needle-based injection systems (NIS). 

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MedinCell’s Partner Teva Announces Successful Launch of UZEDY™

Businesswire | August 03, 2023

MedinCell During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI). About UZEDY Richard Francis said1 “We are actually right on plan or slightly ahead of our market access strategy targets and we are very happy with the launch.” “The newest member of our innovative family is said risperidone, our long-acting treatment for schizophrenia. Now, to remind everybody, this is a $4 billion market and we've only just launched UZEDY, but we're very pleased with the feedback we're getting from healthcare professionals. And they're confirming that the product profile that we have is unique and advantageous. Now we're seeing this in the fact that our NBRX2 is 40%, so already we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests, and we're having good discussions with our payers. So once again, I think excitement around UZEDY early days, but initial feedback is very positive.” UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology. MedinCell is eligible for up to $105m commercial milestones and for royalties on net sales. About LAI olanzapine (mdc-TJK), initiated in January 2023 Eric Hughes said1 “Our Olanzapine Phase 3 study is actually enrolling very quickly.” “Olanzapine as an oral agent account for 20% of the patients being treated today, but only less than 1% of patients on the long-acting form are being using that product. And that's primarily because of the safety profile3.” Richard Francis, said1 “With olanzapine, I've already highlighted the fact that it's a $4 billion market. But if we do manage to bring this to the market with a favorable safety profile, I think we have a real opportunity to have a significant product on our hands here.” mdc-TJK is an investigational long-acting injectable olanzapine also based on BEPO technology. If approved, it could be the first olanzapine LAI with a favorable safety profile offering a valued treatment option as a complement to UZEDY for severe schizophrenia patients. MedinCell is eligible for $12m left out of $17m of development milestones, for up to $105m commercial milestones and for royalties on net sales. About MedinCell MedinCell is a commercial-stage technology pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine already known and used active ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™.

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Multistakeholder Collaborations are Vital to Advancing Technologies in Parkinson's

PRNewswire | July 10, 2023

Critical Path Institute (C-Path) and the Center for Health + Technology (CHeT) at University of Rochester today announced the release of two seminal publications about digital health technologies for Parkinson's. These technologies, such as smartphones and wearable sensors, offer an opportunity for objective, frequent and remote assessment of people with Parkinson's. With 10 million people living with Parkinson's worldwide, collaboration and data sharing are crucial for driving innovation in drug development for the fastest-growing degenerative neurological condition. Research leaders at CHeT have joined forces with organizations and regulators through C-Path's Critical Path for Parkinson's (CPP) Consortium, a precompetitive public-private partnership. CPP aims to accelerate the regulatory endorsement of digital tools in Parkinson's clinical trials through its Digital Drug Development Tools (3DT) initiative. In June 2023, the Journal of Parkinson's Disease published two open access manuscripts, representing companion papers from this partnership that detail steps in conducting interviews of people with Parkinson's who participated in a clinical research study using smartphones. The manuscripts report on relevant symptoms in early Parkinson's and assess the relevance of digital measures from a smartphone application and smartwatch from the patient perspective. The study was led by Jamie Adams, M.D., Associate Professor of Neurology and Associate Director of CheT at the University of Rochester and Jennifer Mammen, Ph.D., Assistant Professor at the University of Rhode Island, with support from CPP. "This project pioneers a new path to efficiently advance tools aligned with the patient voice by engaging with regulatory agencies early and often," said Diane Stephenson, Ph.D., CPP Executive Director. "C-Path remains committed to learning what matters most to people living with Parkinson's." "These manuscripts describe a novel methodology that will help inform the use of digital health technologies in clinical trials for Parkinson's disease and support more objective and patient-centered measures. The goal is to enable efficient, data-driven, and patient-centric utilization of digital health technologies to speed therapeutic development," said Adams. "Sharing the results with the study participants and witnessing how this information helped them in new ways has been most rewarding." John Crawford, a CPP advisor, Parkinson's advocate, and manuscript coauthor states, "Digital health technologies have the potential to significantly impact Parkinson's management and have already revolutionized clinical trial conduct. Their advancement expedites trials, enhances intelligence, reduces costs, and ultimately accelerates the delivery of new therapies and technologies to patients." The new publications coincide with CPP's participation in the World Parkinson's Congress taking place in Barcelona, Spain July 4-7, 2023. CPP will present two posters, Recommendations for Parkinson's Clinical Trials using Digital Health Technologies and Worldwide Collaborative Framework for Optimizing New Parkinson's Treatment Trials with Patient Centric Outcome Measures, at the conference coauthored by people living with Parkinson's highlighting the importance of worldwide collaborations. About Critical Path Institute Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona and C-Path Europe is headquartered in Amsterdam, Netherlands with additional staff in multiple other locations. C-Path FDA Acknowledgement The Center for Health + Technology (CHeT) is an academic research organization within the University of Rochester Medical Center. We are comprised of six units, with expertise in clinical trials coordination, clinical materials services, patient and caregiver-reported outcome measures, tech research and innovation, data modeling and predictive analysis, and health policy. Our skilled team of consultants are readily available to provide guidance to academic institutions, pharmaceutical companies, technology firms, not-for-profit foundations, advocacy groups, and the federal government.

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Altro Pharmaceuticals Teams Up With LSPedia to Provide Cutting-Edge Technology for FDA DSCSA Compliance

PRNewswire | July 31, 2023

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Business Insights, PHARMACY MARKET

MedinCell’s Partner Teva Announces Successful Launch of UZEDY™

Businesswire | August 03, 2023

MedinCell During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI). About UZEDY Richard Francis said1 “We are actually right on plan or slightly ahead of our market access strategy targets and we are very happy with the launch.” “The newest member of our innovative family is said risperidone, our long-acting treatment for schizophrenia. Now, to remind everybody, this is a $4 billion market and we've only just launched UZEDY, but we're very pleased with the feedback we're getting from healthcare professionals. And they're confirming that the product profile that we have is unique and advantageous. Now we're seeing this in the fact that our NBRX2 is 40%, so already we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests, and we're having good discussions with our payers. So once again, I think excitement around UZEDY early days, but initial feedback is very positive.” UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology. MedinCell is eligible for up to $105m commercial milestones and for royalties on net sales. About LAI olanzapine (mdc-TJK), initiated in January 2023 Eric Hughes said1 “Our Olanzapine Phase 3 study is actually enrolling very quickly.” “Olanzapine as an oral agent account for 20% of the patients being treated today, but only less than 1% of patients on the long-acting form are being using that product. And that's primarily because of the safety profile3.” Richard Francis, said1 “With olanzapine, I've already highlighted the fact that it's a $4 billion market. But if we do manage to bring this to the market with a favorable safety profile, I think we have a real opportunity to have a significant product on our hands here.” mdc-TJK is an investigational long-acting injectable olanzapine also based on BEPO technology. If approved, it could be the first olanzapine LAI with a favorable safety profile offering a valued treatment option as a complement to UZEDY for severe schizophrenia patients. MedinCell is eligible for $12m left out of $17m of development milestones, for up to $105m commercial milestones and for royalties on net sales. About MedinCell MedinCell is a commercial-stage technology pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine already known and used active ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™.

Read More

Pharma Tech

Multistakeholder Collaborations are Vital to Advancing Technologies in Parkinson's

PRNewswire | July 10, 2023

Critical Path Institute (C-Path) and the Center for Health + Technology (CHeT) at University of Rochester today announced the release of two seminal publications about digital health technologies for Parkinson's. These technologies, such as smartphones and wearable sensors, offer an opportunity for objective, frequent and remote assessment of people with Parkinson's. With 10 million people living with Parkinson's worldwide, collaboration and data sharing are crucial for driving innovation in drug development for the fastest-growing degenerative neurological condition. Research leaders at CHeT have joined forces with organizations and regulators through C-Path's Critical Path for Parkinson's (CPP) Consortium, a precompetitive public-private partnership. CPP aims to accelerate the regulatory endorsement of digital tools in Parkinson's clinical trials through its Digital Drug Development Tools (3DT) initiative. In June 2023, the Journal of Parkinson's Disease published two open access manuscripts, representing companion papers from this partnership that detail steps in conducting interviews of people with Parkinson's who participated in a clinical research study using smartphones. The manuscripts report on relevant symptoms in early Parkinson's and assess the relevance of digital measures from a smartphone application and smartwatch from the patient perspective. The study was led by Jamie Adams, M.D., Associate Professor of Neurology and Associate Director of CheT at the University of Rochester and Jennifer Mammen, Ph.D., Assistant Professor at the University of Rhode Island, with support from CPP. "This project pioneers a new path to efficiently advance tools aligned with the patient voice by engaging with regulatory agencies early and often," said Diane Stephenson, Ph.D., CPP Executive Director. "C-Path remains committed to learning what matters most to people living with Parkinson's." "These manuscripts describe a novel methodology that will help inform the use of digital health technologies in clinical trials for Parkinson's disease and support more objective and patient-centered measures. The goal is to enable efficient, data-driven, and patient-centric utilization of digital health technologies to speed therapeutic development," said Adams. "Sharing the results with the study participants and witnessing how this information helped them in new ways has been most rewarding." John Crawford, a CPP advisor, Parkinson's advocate, and manuscript coauthor states, "Digital health technologies have the potential to significantly impact Parkinson's management and have already revolutionized clinical trial conduct. Their advancement expedites trials, enhances intelligence, reduces costs, and ultimately accelerates the delivery of new therapies and technologies to patients." The new publications coincide with CPP's participation in the World Parkinson's Congress taking place in Barcelona, Spain July 4-7, 2023. CPP will present two posters, Recommendations for Parkinson's Clinical Trials using Digital Health Technologies and Worldwide Collaborative Framework for Optimizing New Parkinson's Treatment Trials with Patient Centric Outcome Measures, at the conference coauthored by people living with Parkinson's highlighting the importance of worldwide collaborations. About Critical Path Institute Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona and C-Path Europe is headquartered in Amsterdam, Netherlands with additional staff in multiple other locations. C-Path FDA Acknowledgement The Center for Health + Technology (CHeT) is an academic research organization within the University of Rochester Medical Center. We are comprised of six units, with expertise in clinical trials coordination, clinical materials services, patient and caregiver-reported outcome measures, tech research and innovation, data modeling and predictive analysis, and health policy. Our skilled team of consultants are readily available to provide guidance to academic institutions, pharmaceutical companies, technology firms, not-for-profit foundations, advocacy groups, and the federal government.

Read More

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Altro Pharmaceuticals Teams Up With LSPedia to Provide Cutting-Edge Technology for FDA DSCSA Compliance

PRNewswire | July 31, 2023

LSPedia, a leading SaaS provider specializing in product traceability solutions for the pharmaceutical industry, has partnered with Altro Pharmaceuticals, enabling Altro customers to easily comply with the Drug Supply Chain Security Act (DSCSA) ahead of the FDA's final deadline on November 27, 2023. Altro provides expertise and services to pharmaceutical manufacturers and wholesale distributors, helping them expand their businesses, streamline supply chain operations, increase efficiency, and more. Now, its services include proven, worry-free turnkey DSCSA compliance, thanks to LSPedia's easy-to-use, comprehensive OneScan software suite. Sandy Greco, President of Altro Pharmaceuticals, noted, "Getting DSCSA right is essential to the smooth flow of business in the pharma supply chain, so we take it incredibly seriously, and we absolutely want our customers to succeed with it. LSPedia has the industry's best track record for user experience, scalability, and success – we can say for sure we're offering the best service available." LSPedia's OneScan Suite enables manufacturers and wholesalers to quickly achieve full compliance with all DSCSA requirements, including serialization, sending and receiving EPCIS data, verification, and interoperability. Further, the solution includes access to LSPedia's Investigator for Exceptions Management, the industry's gold standard for alerting, resolving, and preventing EPCIS transaction errors. "Altro is a perfect partner for LSPedia," said LSPedia CEO Riya Cao. "With so little time left before the compliance deadline, access and convenience are essential. Altro supports its customers with a deep service portfolio, and there's every reason it should include easy, complete DSCSA compliance." About LSPedia LSPedia is a leading provider of turnkey DSCSA compliance and SaaS solutions in the pharmaceutical industry. CMOs, manufacturers, 3PLs, wholesale distributors, dispensers, and healthcare providers use LSPedia's OneScan solution to make, move, track, verify, ship, and receive serialized products at every point in the supply chain. As the largest processor of serialized data in the industry, LSPedia builds solutions with workflow, automation, and data security at their core. OneScan delivers flexible integrations, high-performance product verification, and state-of-the-art EPCIS data exchange; LSPedia's Investigator platform is the gold standard for serialization exceptions management, as the first collaborative platform to resolve EPCIS errors and supply chain issues in real time.

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