BUSINESS INSIGHTS, PHARMACY MARKET
PRNewswire | May 03, 2023
ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems, and MEPHARMA, a strategic regulatory consulting services company, have partnered to provide a range of regulatory intelligence, compliance, and validation and automation solutions for companies in the United Arab Emirates (UAE) and the Middle East and North Africa (MENA).
MEPHARMA provides high-quality regulatory consulting services in addition to a host of other specialized services, including pharmacovigilance, GxP, due diligence and auditing for pharmaceutical, biotechnology and contract research organizations (CRO).
ValGenesis is the market leader in enterprise Validation Lifecycle Management Systems (VLMS), helping the world's leading life sciences companies enforce compliance and enable standardization with 100% digital, risk-based validation software.
Combining their extensive experience, MEPHARMA and ValGenesis are poised to expand next-generation digital validation and compliance solutions into countries in the MENA region.
"We are excited to partner with MEPHARMA and empower companies in this region with cutting-edge digital transformation tools that advance them on their Pharma 4.0 journey," says Bo Olsen, ValGenesis' SVP of Partners. "Together we provide well-defined, robust validation lifecycle management strategies and solutions that enable companies adhere to the most stringent global regulatory requirements."
"We are thrilled to collaborate with ValGenesis, the enterprise Validation Lifecycle Management Systems leader, to bring comprehensive regulatory intelligence, compliance, and validation solutions to local manufacturing companies in the UAE and MENA region," says Dr. Ayman Mahmoud, Managing Director at MEPHARMA. "Our partnership with ValGenesis will empower regional life sciences companies to streamline their validation processes and achieve maximum compliance with the highest GMP regional and global standards. Together, we are committed to delivering exceptional value to our clients and supporting their digital transformation journey towards Pharma 4.0."
ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.
PRNewswire | May 19, 2023
Asieris Pharmaceuticals a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced a strategic collaboration with UroViu Corporation ("UroViu"). Asieris Pharmaceuticals will obtain exclusive global rights to UroViu's patented technology of portable single-use cystoscope in the field of fluorescent imaging.
Under the agreement, Asieris Pharmaceuticals will use this patented technology in combination with specific optical imaging agents to conduct research on the application of non-white light imaging technology in the diagnosis and postoperative monitoring of None-Muscle Invasive Bladder Cancer (NMBC). At the same time, Asieris Pharmaceuticals will be responsible for the global commercialization of the sterile single-use fluorescent Cystoscope.
Previously, Asieris Pharmaceuticals entered a cooperation agreement with UroViu in 2021 for the exclusive registration and commercialization rights of its portable single-use flexible white light cystoscopy system in mainland China, Taiwan, Hong Kong and Macau.
"There is still a huge unmet need for more accessible and safer fluorescent cystoscopy in the diagnosis and surveillance of bladder cancer."Dr. Susan Wang, Senior Vice President of Global Business Development & Strategic Partnership of Asieris said, "We are thrilled to deepen and expand our collaboration with UroViu which enabling us not only to broaden our technology portfolio, but also to expedite the implementation of Asieris' integrated strategy for bladder cancer diagnosis and treatment, aiming to provide more effective disease management options for bladder cancer patients."
"We are excited about the possibilities that our expanded Partnership with Asieris will create. Our unique and expanding portfolio of single use endoscopic products are fulfilling UroViu's promise to greatly improve both the patient and provider experience, elevate the standard of care in a field with rapidly advancing technologies," said Bruce OuYang, Founder and CEO of UroViu.
Asieris Pharmaceuticals founded in March 2010, is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet medical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.
businesswire | April 03, 2023
Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapeutic areas, today announced that it has entered into a platform research evaluation collaboration and option agreement with Regeneron Pharmaceuticals, Inc. Under the terms of the agreement, Xeris will use its proprietary drug-formulation platform, XeriJect™, to develop ultra-highly concentrated, ready-to-use, small volume subcutaneous injections of two undisclosed monoclonal antibodies developed by Regeneron. Xeris will receive an upfront payment and potential milestone payments for preclinical achievements. Regeneron has an option to commercially license the Xeris technology for such molecules and nominate additional molecules for reformulation and potential commercialization. Specific financial terms of the agreement were not disclosed.
“We are excited to be working with Regeneron on a platform collaboration basis, which builds on our prior feasibility studies and reflects the significant progress and investment we have been making into the development of XeriJect™,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Through our novel drug-formulation platform, we aim to provide our biologic development collaborators with the competitive advantage of delivering a significantly improved patient and provider experience through stable, ready-to-use, ultra-highly concentrated, small-volume subcutaneous injection formulations. This agreement with Regeneron is another in a series of collaborations Xeris has recently undertaken with top pharmaceutical and biotechnology companies.”
Xeris’ drug-delivery system, XeriJect, provides innovative, ready-to-use, viscoelastic pharmaceutical suspensions that have the potential to improve drug delivery, lower treatment burden and improve patients' lives across a broad range of therapeutic categories. XeriJect suspensions maximize drug loadings at >450mg/mL, enable small volume subcutaneous injections, do not settle on storage and are ready-to-use. The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation technology is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing.
Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and innovative products across a range of therapies. Xeris has three commercially available products: Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; Keveyis®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a diverse pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support long-term product development and commercial success.