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.
Businesswire | July 07, 2023
Cytel Inc., provider of quantitative insights and health data analytics to leaders in life sciences, has acquired stève consultants, specialists in market access, real-world (RWE), and health economics and outcomes research (HEOR). The acquisition further expands Cytel’s real-world & advanced analytics (RWAA) capabilities, giving sponsors an expanded global offering, with access to additional specialists and localized expertise. This acquisition continues the company’s growth in key European markets, following the recent acquisition of Nordic regulatory affairs and RWE experts SDS Life Science. Cytel now stands as one of the largest global providers of HEOR, RWE, global value strategy and market access consulting.
Achieving favorable market access is crucial in today’s highly competitive clinical development environment. But doing so is challenging and requires access to deep region-specific expertise. Cytel has long excelled at using proven quantitative techniques to transform real-world data into actionable insights to help sponsors successfully tap into new markets. The acquisition of stève consultants continues this journey, augmenting and extending the localized market access, product launch, and regulatory support it can offer in France, a critical European market.
"stève consultants have crafted a team of unparalleled know-how in regional market access, HEOR, and RWE,” said Radek Wasiak, General Manager, Real-World and Advanced Analytics (RWAA), Cytel. “We look forward to welcoming them to Cytel as together we can now provide an exceptional service at the local level in France but also plug into the global dossier needs of our clients. For sponsors, this means a more global strategic offering, deeper connectivity to world-class expertise in France, and greater product launch success.”
stève consultants has spent 17 years optimizing the value of its customers’ healthcare products for the French market, with deep expertise in market access, HEOR, and RWE. stève consultants is a leader in market access and one of the largest and most accomplished RWE services providers in France.
“Joining forces with Cytel further expands the insight and support we can offer for market access and market maintenance in France,” said Stève Bénard, Executive Manager, stève consultants. “Both companies share a pioneering spirit, long-held market reputations for scientific rigor, and an excellent client service ethos. We’re proud to play a critical role in augmenting the way sponsors tap into markets and transform patients’ lives.”
The transaction was closed on June 30, 2023. Terms were not disclosed.
Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 2,000 employees across North America, Europe and Asia.
About stève consultants
stève consultants, founded in 2006, is a consulting and research company specializing in optimizing the value of healthcare products on the French market. stève consultants supports its biotech and pharmaceutical clients in the development and the implementation of their regional market access strategy, including the implementation of early access programs, the demonstration of health-economic value, the generation of real-life data and the writing of HTA dossiers. stève consultants is a leader in market access, and one of the most accomplished RWE service providers in France. stève consultants has extensive experience and works on the latest therapeutic innovations.
PHARMACY MARKET, PHARMA TECH
Businesswire | July 12, 2023
Kindeva Drug Delivery, a global leader in contract drug delivery development and manufacturing services and technology, and H&T Presspart (a division of the Heitkamp & Thumann Group), a market leader in respiratory drug delivery systems design, development, and manufacturing, are partnering with Chiesi Group, an international research-focused biopharmaceutical and healthcare group, for the installation of a production line for dose counter (DC) and dose indicator (DI) devices. Combining the specific expertise of each partner, H&T Presspart will manufacture Kindeva Drug Delivery’s dose counters under license for Chiesi Group for their pressurized metered-dose inhaler (pMDI) portfolio.
This partnership is a continuation of the agreement signed in 2014 between Kindeva Drug Delivery and H&T Presspart to accelerate the growth of Kindeva Drug Delivery’s dose counter technology. This technology enhances patient safety by providing real-time information on the remaining doses in inhalers, preventing unexpected shortages. H&T Presspart will expand the cleanroom facilities at their Marsberg, Germany, site to support the dose counter production. As part of this strategic partnership, Chiesi Group will use dose counters in their innovative carbon minimal pMDI portfolio, which uses a low Global Warming Potential (GWP) propellant to minimize the climate impact of the inhalers, while maintaining all the therapeutic options that patients suffering from respiratory diseases need.
David Stevens, global chief commercial officer of Kindeva Drug Delivery, stated: “Kindeva is pleased to extend this strategic partnership as it solidifies our core objective of improving the lives of patients around the world. Kindeva embraces the responsibility it has in ensuring that patients who depend upon our device technology are reliably supplied, and we believe that this innovative supply chain collaboration further underscores this commitment.”
Roberto Della Valle, head of global direct procurement of Chiesi Group, added: “Chiesi, with its patient-centric approach, is dedicated to delivering therapeutic solutions that enhance patients’ health and quality of life. Collaborating with Kindeva and H&T Presspart exemplifies this commitment, and we are thrilled to take this step forward. By providing an inhaler that reassures patients about the remaining dose count, we aim to enhance their safety and confidence.”
Christian Kraetzig, president of H&T Presspart, commented: “With our expertise in device industrialization and manufacturing, this agreement marks another step in our journey to becoming a leading development and contract manufacturing partner in drug delivery devices.”
About Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development manufacturing organization focused on drug-device combination products. Kindeva Drug Delivery develops and manufactures products across a broad range of complex drug-delivery formats, including injectables (autoinjector, intradermal, microneedle), pulmonary & nasal, and transdermal patches. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva Drug Delivery serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K.
About Chiesi Group
Chiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and counts more than 6,500 employees.