BUSINESS INSIGHTS, PHARMA TECH
prnewswire | April 28, 2023
Endo International plc announced that its subsidiaries Endo Ventures Limited and Par Pharmaceutical, Inc. have executed an agreement with Slayback Pharma LLC to distribute Slayback's Prevduo™ (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe on an exclusive basis in the U.S. The U.S. Food and Drug Administration (FDA) approved Prevduo™ in February 2023 for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration.
Endo will commercialize Prevduo™ through its Par Sterile Products business and expects to launch the product in June 2023.
When launched, Prevduo™ will be the first and only FDA-approved neostigmine–glycopyrrolate combination product in the U.S. Both neostigmine methylsulfate and glycopyrrolate have been approved in the U.S. as single, active ingredient drug products. Neostigmine is always administered in conjunction with glycopyrrolate, and currently, its administration requires two syringes.
"Prevduo™ further strengthens our commitment to supporting healthcare providers and their patients through ready-to-use products that streamline operations," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "We're proud to partner with Slayback to bring this critical care product to market and help hospitals deliver quality patient care."
"Following the development and FDA approval of Prevduo™, we're pleased to partner with Endo and tap into Endo's proven capabilities in commercializing injectable solutions, including ready-to-use products," said Ajay Singh, Founder and CEO of Slayback Pharma.
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.
About Endo
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.
Read More
PHARMACY MARKET, PHARMA TECH
prnewswire | April 18, 2023
Science and technology company Merck and XtalPi Inc., a pioneering pharmaceutical technology company powered by artificial intelligence (AI) and automation, have jointly published a study that highlights the benefits of combining computational workflows with wet lab experiments to advance drug development.
Traditional methods like milling and micronization, used to address undesirable crystal morphologies, can be disruptive and costly. In contrast, molecular dynamics simulations offer valuable insights for better crystallization experiment designs.
The collaboration between Merck and XtalPi focused on the impact of different polymer additives on the crystal habit of metformin HCl, a diabetes medication. By combining Merck's experimental capabilities with XtalPi's morphology prediction platform, a comprehensive screening approach for crystal morphology engineering was developed. XtalPi's custom-made force fields successfully predicted the influence of polymer additives on metformin HCl's crystal habits. The addition of HPMC led to a transformation from a needle-like to a prismatic morphology, in agreement with experimental observations. The publication demonstrates the potential of merging computational methods and experimental expertise for drug formulation optimization.
Dr. Peiyu Zhang, XtalPi's Chief Scientific Officer, said, "By integrating XtalPi's molecular dynamics predictions with Merck's experimental validation, we have taken a step towards the rational engineering of desirable crystal habits. We hope to continue improving this 'dry + wet lab' method with leading industry experts like Merck, in the production of novel therapeutics worldwide."
Dr. Jan Gerit Brandenburg, Head of Digital Chemistry at Merck, added, "Our collaboration with XtalPi is transforming pharmaceutical development. By seamlessly incorporating computer simulations with our experimental formulation expertise in a 'digital-first' approach, we are boosting drug development processes and positively impacting patients' lives."
About XtalPi
XtalPi is a quantum physics and AI-powered pharmaceutical technology platform that provides integrated drug discovery solutions for global pharmaceutical companies. XtalPi has pioneered a new model for drug R&D that leverages a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge. The company applies this three-pronged approach in its R&D platform to accelerate the drug discovery and development process and address unmet needs for patients worldwide.
Read More
BUSINESS INSIGHTS, PHARMACY MARKET
prnewswire | April 21, 2023
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.
Read More