The latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.
The latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.
Eversana has released its Navlin software ecosystem of price and access solutions, intended to help both established and emerging pharma firms navigate global access complexities. According to the company, it combines data, software, and insights in one platform, with support from industry experts.
Jim Lang, CEO of Eversana, said, “We’ve created an unmatched, easy-to-navigate view of the global price and market access ecosystem. Our clients now have the insights, data and software they need to navigate product performance from pre-launch through loss of exclusivity in over 100 global markets. It’s the perfect complement to Eversana’s fully integrated commercialization services.”
IQVIA has added OCE+, a daily workflow tool offering artificial intelligence-driven recommendations for engaging healthcare professionals to its Orchestrated Customer Engagement technology. OCE+ reportedly provides commercial teams with HCP-specific actions to take, such as recommending the best time to engage and the best method of contact.
“IQVIA is uniquely positioned to bring together data, analytics, technology, and AI/ML capabilities all under one roof,” said Sanjay Chikarmane, chief product officer of IQVIA. “With OCE+, our customers can make smarter and more informed decisions through embedded intelligence that surfaces the actionable insights they need, when they need them, to better personalize the HCP experience and improve business results.”
Evonik has launched Eudratec Solflow, a microparticle technology intended to enhance solubility of active pharmaceutical ingredients in oral drug products. This emulsion-based process technology reportedly overcomes solubility hurdles not able to be resolved by other manufacturing technologies.
“Our new technology opens doors to a wider spectrum of oral drugs by enabling the use of molecules that were previously considered insoluble,” said Paul Spencer, head of the product line Drug Delivery & Medical Device Solutions at Evonik’s Health Care business. “We look forward to working with customers to develop oral drugs for better, healthier lives.”
SGD Pharma has added 100 ml ready-to-use Type I molded glass vials to its Sterinity platform. The vials are intended for aseptic fill/finish of parenteral drug products.
Alexander Bautista, product manager for the Sterinity platform, said, “SGD Pharma is the sole player in the market that is currently offering 100 ml molded glass vials in SG EZ-fill trays and it’s important for us to be at the forefront of this innovation. Currently, 100 ml represents the boundary between small and large parenteral vials and by introducing sterile empty vials in this size, we can offer drug manufacturers and pharmacists an alternative option.”
TFF Pharmaceuticals and Catalent have announced a collaborative agreement centered on generation, testing and manufacture of dry-powder formulations for a range of biotherapeutics, using TFF’s thin-film freezing technology. Catalent will provide scale-up expertise and manufacturing capabilities to TFF Pharmaceuticals as its preferred development and manufacturing partner, and Catalent will have the right to offer its customers access to the TFF technology.
“Catalent is widely known as a global leader in enabling pharmaceutical development and manufacturing and has distinguished itself by demonstrating cutting-edge expertise across multiple modalities and innovative projects,” said Glenn Mattes, CEO of TFF Pharmaceuticals. “This strategic collaboration significantly expands our access to manufacturing capabilities and provides scalability for our technology, while simultaneously affording us the opportunity to build our portfolio of technology licensing partnerships.”
MMIT’s has announced the launch of its Patient Access Analytics solution, designed to give pharma commercial teams the ability to quickly analyze and visualize multiple longitudinal, real-world patient data sets to instantly obtain answers to questions regarding access barriers and prescribing patterns. It reportedly makes it possible for claims data to be visualized in an integrated fashion, alongside MMIT’s policy and restriction coverage data.
“Smoothing a patient’s access to lifesaving treatments is our true north, and we’re proud to offer this industry-leading solution that delivers instant answers—not just insights—so that pharma manufacturers can make strategic, data-driven decisions in real time,” said MMIT CEO Mike Gallup.
Quotient Sciences has announced the integration of drug substance into its Translational Pharmaceutics platform. The newly integrated service unites drug substance, drug product and clinical testing activities within a unified organization and under a single project manager.
Mark Egerton, Quotient Sciences CEO, said, “We remain the only outsourcing partner able to offer innovators the ability to manufacture, release, and dose under one organization. This approach is proven to shave 12-months off timelines and, by adding drug substance synthesis, the timeline from candidate selection to clinic can be further accelerated by two to four months.”
WuXI STA has announced its Waigaoqiao site in Shanghai, China, as successfully passed the first drug product pre-approval inspection (PAI) by the US Food and Drug Administration (FDA). During the five-day inspection in October, the FDA inspector assessment included manufacturing facility and equipment, laboratories, quality management system, tablet production, material handling, computer control systems, and data integrity.
Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA, said, “I am very pleased that our drug product platform in Waigaoqiao has successfully passed its first PAI by the US FDA. It is another milestone that the site starts to provide commercial drug product manufacturing services to the US market. With our industry-leading global CMC platform and proven quality system, we strive to empower more partners to accelerate their innovative medicines to market for patients worldwide.”
Thermo Fisher Scientific and Symphogen plan to extend their collaboration to provide biopharmaceutical discovery and development laboratories with tools and workflows for efficient characterization of complex therapeutic proteins. The collaboration first started in 2018.
"The extension of our collaborative relationship with Symphogen demonstrates our continued commitment to solve tangible scientific challenges within the biopharmaceutical industry," said Eric Grumbach, director of biopharma and pharma business, chromatography, and mass spectrometry with Thermo Fisher. "Further investment in this collaboration enables critical insights that feed directly into the development of new analytical tools, providing meaningful impact to the characterization of complex biotherapeutics."
Schreiner MediPharm has introduced a tamper protection label with clear, irreversible first-opening indication for vials. The product reportedly can help prevent unauthorized and illegal reuse of original containers and thwart counterfeiting.
The new security label wraps around the vial up to the level of the cap; to open the vial, the user peels off a label-integrated tear strip that cannot be resealed unnoticed. A warning message clearly indicating that the vial has been opened emerges.
