Pharmacy Market
Businesswire | July 26, 2023
Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Sterile Water for Injection, USP in 10mL and 20mL Single-Dose Vials.
According to the FDA and the FD&C Act, the product is considered bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sterile Water for Injection USP, of Hospira, Inc. Furthermore, the FDA has granted CGT (competitive generic therapy) designation for the 20mL presentation of sterile water for injection.
“We are proud to be a force for change in the pharmaceutical industry, and we are grateful to the FDA for recognizing the importance of this critical-need product,” said Aman Ahmed, Director of Government Relations and International Sales at Nexus. “The approval of this product is an important step in continuing our efforts to alleviate drug shortages and bring pharmaceutical manufacturing back to the U.S.”
Nexus Pharmaceuticals’ Sterile Water for Injection will be available in cartons of 25 vials.
About Sterile Water for Injection, USP
Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection.
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
About Nexus Pharmaceuticals LLC
Nexus Pharmaceuticals LLC., a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.
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Pharmacy Market
PRNewswire | July 11, 2023
Signant Health, the leader in evidence generation for modern clinical trials, announced expanded flexibility and capabilities for its leading Signant SmartSignals Supplies software, empowering small and mid-size customers to experience the advantages of technology-driven clinical supply management.
Relaunched as Signant SmartSignals Supplies GxP Inventory, the solution provides sponsors and contract research organizations (CROs) with efficient, comprehensive management and oversight of the end-to-end supply chain. Unlike spreadsheet-based supply chain management, the GxP Inventory solution offers centralized, full visibility of clinical trial material creation, release, and distribution activities within a single system. Available as either an Essential or Enterprise option, clinical research sponsors can select the optimal solution for their needs, which is often dictated by size or trial volume.
The Essential option enables sponsors to deploy quickly using our pre-configured system for inventory manufacturing, management, and QA/QP release. The Enterprise option provides more advanced features for larger customers with internal supply chain capabilities to meet more individualized requirements, sponsor-specific terminology/labels, and additional workflow/process options. Both options are SaaS-based for cost-effective implementation, reduction of internal technology investments, and ease of ongoing maintenance.
"Signant is extremely proud of its heritage as a leading provider of GxP inventory management solutions to many top-20 sponsor organizations. Our Essential option now extends the same benefits to smaller sponsors and CROs who wish to have the same level of inventory control, regulatory compliance, and visibility in a more compact, per-protocol commercial offering," said Sanjiv Waghmare, Signant's chief product officer.
Technology-based solutions make clinical trials safer for patients through better visibility and control of supplies, particularly with respect to investigational products. From sourcing drug substance ingredients to randomized patient kits, these solutions ensure that all supply chain data is in one place, and not distributed across spreadsheets, emails, and external inventory management systems. With the launch of the Essential option, we are making the technology-based solution for clinical supply management accessible to sponsors of all sizes.
About Signant Health
Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics.
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Pharmacy Market
PRNewswire | July 21, 2023
Catalyst Clinical Research an industry-leading provider of specialized clinical development solutions, announced today it has acquired Genpro Research ("Genpro"), a Massachusetts-based global clinical research organization with staff in the US, India, and Ireland.
Genpro is a next generation services and technology partner for the pharmaceutical, biotechnology, and medical devices industry with expertise in biometrics, medical writing, RWE, and AI enabled automation product development. Genpro will continue to be led by Dr. Sachin Marulkar and the existing management team.
Commenting on the announcement, Catalyst CEO Nick Dyer said, "We are hugely enthusiastic about the addition of Genpro to our family. We share the opportunity to expand our global footprint, broaden and deepen our services, and to use the AI platform to create value for ourselves and customers in a range of labor-intensive document creation processes. In addition, our approach to prioritizing culture and treating our teams like family are similar and will act as a critical foundation for our combined company as we move forward."
Genpro CEO Dr. Sachin Marulkar added, "By joining Catalyst, we will continue to expand our biometrics, scientific reporting and technology offerings, have access to more opportunities globally, and provide our clients with additional products and services. We are excited to utilize the synergies in advancing our AI/ML technology platform to create beneficial new tools and improve the efficiency of clinical research. Catalyst is highly aligned with our purpose, values, and our relationship-driven focus. We look forward to stepping into these opportunities while still acting with the speed and flexibility our customers value and maintaining the collaborative culture that is so important to our employees."
This acquisition adds more than 120 team members in India with expertise in biometrics and medical writing further bolstering Catalyst's robust functional service offerings. This further enables biopharma, MedTech and CRO clients (current and future) to access Catalyst's specialized clinical research services, along with broader expertise in global time zones, new solutions, and early access to innovative automation platforms.
Melissa Church, Senior Vice President, Strategy at Catalyst, expressed the strategic significance of the acquisition, emphasizing its importance in advancing Catalyst's commitment to providing top-notch specialized clinical development solutions. She stated, "Catalyst is extremely intentional in its acquisition approach, ensuring we choose organizations that are additive to our capabilities and match well with our people-first culture. In Genpro we are gaining a very talented team delivering function specific biometrics and medical writing services which fits squarely in our strategic growth plan supporting both our Catalyst Flex and Catalyst Oncology solutions. This creates more value for our customers, collaborators, partners and investors long term."
Highlighting scientific and innovation focus of the deal, Kapil Khambholja, Genpro's CSO and Practice Head of Medical Writing, Real-World Evidence, and Health Economics and Outcomes Research (RWE & HEOR) emphasised both company's shared commitment for advancing therapies beyond milestones to transforming lives. Dr Kapil stated, "This partnership will propel Genpro's automation roadmap forward, aligning strategically with Catalyst's interests. We are also thrilled to see Genpro's scientific initiatives gaining momentum, and we eagerly anticipate collaborating with Catalyst's dedicated team to inspire advancements of breakthrough therapies touching lives."
About Catalyst Clinical Research
Catalyst is a clinical research organization (CRO) that provides highly customizable solutions to the global biopharmaceutical industry through two established, branded solutions: Catalyst Oncology and Catalyst Flex. The company provides full-service oncology CRO offerings through Catalyst Oncology and multi-therapeutic Client- or Catalyst-managed functional services through Catalyst Flex. With around 1000 staff and offices in the United States, Europe, and Asia-Pacific regions, Catalyst's flexible service model is built from more than a decade of listening to customers, devising customer-centric solutions, and helping customers drive breakthrough clinical studies by leveraging expert teams and innovative technologies.
Catalyst is a portfolio company of QHP Capital, a leading healthcare and life sciences investment firm.
About Genpro Research
Genpro Research is a technology and services partner dedicated to serving the pharmaceutical, biotechnology, and medical devices industries. By providing expertise in biostatistics, data sciences, medical writing & evidence synthesis, the focus has been on thoughtful service execution on clinical studies. And, as an experienced technology provider, Genpro uses Artificial Intelligence, Machine Learning, and Natural Language Processing algorithms for clinical development and post-launch activities, Genpro's central commercial platform called MaiA is used for Evidence Generation and Study Report Automation that brings depth and clarity to enable informed decision making.
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