Business Insights, PHARMA TECH
PRNewswire | July 19, 2023
Endo International plc announced that its Par Sterile Products business has begun shipping bivalirudin injection in a ready-to-use 250 mg/50 mL single-use vial. It is the only ready-to-use liquid format of bivalirudin on the market in the U.S.
"Hospital practitioners work hard to provide quality patient care while also meeting operational challenges," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "With ready-to-use products like bivalirudin, we're helping to deliver solutions that reduce complexity for healthcare providers—so they can focus on patient care."
In May 2023, Endo executed agreements with MAIA Pharmaceuticals, Inc. and Gland Pharma Limited, India to commercialize ready-to-use bivalirudin in the U.S. The product, manufactured by Gland Pharma Limited, is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots. It is used to prevent blood clots in people with severe chest pain or other conditions who are undergoing an angioplasty procedure.
Ready-to-use, or RTU, products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care
In clinical trials in patients undergoing percutaneous coronary intervention (PCI), co-administration of bivalirudin with heparin, warfarin, thrombolytics, or GPls was associated with increased risks of major bleeding events compared to patients not receiving these concomitant medications.
USE IN SPECIFIC POPULATIONS
In studies of patients undergoing PCI, 44% were ≥65 years of age and 12% of patients were ≥75 years old. Elderly patients experienced more bleeding events than younger patients.
The disposition of bivalirudin was studied in PTCA patients with mild, moderate and severe renal impairment. The clearance of bivalirudin was reduced approximately 21% in patients with moderate and severe renal impairment and was reduced approximately 70% in dialysis- dependent patients. The infusion dose of bivalirudin injection may need to be reduced, and anticoagulant status monitored in patients with renal impairment.
INDICATION AND USAGE
Bivalirudin injection is indicated for use as an anticoagulant in patients undergoing PCI, including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them.
Businesswire | July 25, 2023
ImmunoGen, Inc. a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced a multi-target license and option agreement to research novel, first-in-class ADCs with ImmunoBiochem Corporation, a privately-held biopharmaceutical company focused on the discovery of unique tumor targets and development of novel biological therapeutics. The collaboration will combine ImmunoGen's proprietary linker-payload technology with ImmunoBiochem's antibodies directed against specific targets.
"We are excited to partner with ImmunoBiochem, which brings a novel approach to tumor targeting for ADCs," said Eric Westin, ImmunoGen's Vice President of Clinical Development and Translational Sciences. "This agreement reflects our commitment to leverage our rich IP portfolio through strategic partnering in order to further reinvigorate our research and development in support of our pipeline."
Under the terms of the agreement, ImmunoBiochem will receive an upfront payment in exchange for providing ImmunoGen with an exclusive license to existing antibodies directed against a specific undisclosed target. ImmunoBiochem will be eligible to receive milestone payments and royalties based on the achievement of pre-specified development, regulatory, and commercial milestones. ImmunoGen will collaborate with ImmunoBiochem on preclinical activities and assume responsibility for the program's future clinical development and commercialization activities. ImmunoGen will also have the option to select additional targets and antibodies to license based on certain preclinical work undertaken by ImmunoBiochem. If ImmunoGen chooses to exercise this option, ImmunoBiochem will receive an option exercise payment and ImmunoGen will assume responsibility for all subsequent R&D associated with that program.
"ImmunoBiochem is extremely pleased that ImmunoGen, one of the world's leading ADC companies, will help catalyze the unique science and assets that we have been developing to engender novel strategies to tackle difficult solid tumors, particularly for patients that lack common tumor targets," said Dr. Anton Neschadim, CEO of ImmunoBiochem. "This partnership validates our differentiated thinking and will enable ImmunoBiochem to significantly expand its discovery platform and innovative pipeline."
ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™.
ABOUT IMMUNOBIOCHEM CORPORATION
ImmunoBiochem is an innovative biopharmaceutical company on a mission to develop novel biological therapeutics to address significant unmet need in oncology and immuno-oncology. ImmunoBiochem uses a combination of high-throughput functional screens, bioinformatics and AI/ML to unravel unique biology in the tumor microenvironment, particularly in the cancer cell secretome, and to discover novel tumor targets that could be exploited with various targeted therapeutic modalities. ImmunoBiochem, a Johnson & Johnson Innovation JLABS alumnus, is headquartered in Toronto, at the heart of Canada's largest biomedical research hub, and has worked closely on some of its novel programs with the University of Toronto, Canada's top university and amongst the world's leading institutions in research and innovation.
prnewswire | September 01, 2023
Evolution Health Group (EHG), a leading name in medical communications, pharmaceutical strategic marketing, and digital solutions, unveiled its game-changing technology platform, 360Connex®, set to redefine the landscape of stakeholder engagement. The primary objective of this robust platform is to enable enterprises to scale and target their engagement initiatives effectively. With a focus on efficiency, transparency, and actionable insights, organizations can now make data-driven decisions and foster stronger relationships with their stakeholder communities.
This state-of-the-art platform is geared towards three core functionalities
Management, Monitoring, and Measurement of Stakeholder Engagement: Through an intuitive interface and innovative technologies, enterprises can now efficiently manage, track, and measure the impact of their interactions with their key stakeholders, streamlining the collaboration process and helping teams focus their resources and strategies to ensure maximum impact on the business.
Facilitation of Speaker Programs: The platform offers tools that will not only simplify the coordination and execution of speaker programs, but also ensure they meet the highest standards of content delivery and engagement.
Application of Advanced Analytics: By harnessing the power of artificial intelligence, machine learning, and advanced automation technologies, EHG's 360Connex® platform offers unprecedented insights and optimization opportunities. This ensures that engagement activities are not only scaled, but also aligned with the dynamic needs of the stakeholder community. The platform is designed to meet the differing needs of emerging organizations through the largest of enterprises.
"The healthcare community is rapidly evolving, and traditional methods of engagement are no longer sufficient. Our new technology platform bridges the gap, empowering enterprises to create more impactful, meaningful, and measurable interactions with their key stakeholders in a cost-effective way that ensures ongoing transparency and accountability," commented Carolyn Vogelesang Harts, one of the Managing Partners of Evolution Health Group.
The unveiling of 360Connex® comes at a pivotal moment in the healthcare industry. As interactions between enterprises and healthcare professionals become increasingly intricate, there is a pressing need for systems that simplify processes and provide actionable insights. EHG's 360Connex® platform is the answer to this pressing demand.
This innovation is poised to usher in a new era of insight-driven engagement, ensuring that healthcare companies not only keep pace with, but also anticipate the needs of, their diverse professional audiences.
About Evolution Health Group
Founded in 2005 and based in Pearl River, NY, Evolution Health Group stands at the forefront of pharmaceutical strategy, marketing, and digital solutions for global healthcare companies. EHG provides distinctive services through three main divisions; Evolution Medical Communications for medical and scientific strategy, blulava, for technology and digital solutions, and Maestro360 for speaker program logistic management.