PHARMA TECH
prnewswire | May 30, 2023
ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems announced that a leading pharmaceutical company in Brazil selected ValGenesis iRisk to redefine and automate the company's risk-based validation processes. ValGenesis iRisk is the world's most advanced risk management platform, used by top pharmaceutical companies across the world.
With corporate origins in Japan, the company draws upon a rich legacy of innovation and a pipeline of robust therapeutics that are enhancing the lives of millions of people across the globe.
Working to keep pace with ever-changing business and regulatory landscapes, the company chose ValGenesis iRisk because it enhances business performance and business process excellence across end-to-end product and process lifecycles. On this compliant platform, experts can analyze, visualize, query, and compare risk over different products, processes, production sites, and more, sharing a continuous flow of risk communications between relevant stakeholders to get products to market more quickly and safely.
"Brazil is the largest pharmaceutical market in Latin America, and we are happy that more companies are turning to ValGenesis for risk-based validation solutions that enforce a structured and consistent approach to risk, " says Steve Reynolds, Chief Revenue Officer at ValGenesis. "ValGenesis iRisk is able to deliver on these stringent requirements simply, efficiently, and very cost-effectively."
ABOUT VALGENESIS
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.
Read More
BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | April 06, 2023
Societal CDMO, Inc. a contract development and manufacturing organization announced that it has been selected by Longboard Pharmaceuticals, Inc. to provide CDMO services. The agreement spans a range of Societal CDMO’s offerings including technology transfer and analytical method validation activities to support Longboard’s lead asset, LP352, a 5-HT2C receptor superagonist. LP352 is currently being evaluated in the PACIFIC Study, a Phase 1b/2a basket trial, in participants with developmental and epileptic encephalopathies or DEEs, such as Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, CDKL5 deficiency disorder, SCN2A-related disorders, among others.
“This agreement with Longboard offers an excellent illustration of the strides that Societal CDMO continues to make in establishing itself as a preferred CDMO partner for biopharmaceutical companies developing innovative therapeutic candidates. The scope of work for this project highlights the broad range of services we offer to support drug developers as they advance their innovative candidates through clinical development, spanning tech transfer through to cGMP manufacturing,” said David Enloe, chief executive officer of Societal CDMO. “We are grateful for the trust that Longboard has placed in our team to make a contribution to the development of an important therapeutic that has the potential to meaningfully impact the lives of patients in need. At the end of the day, that is the mission that drives all members of the Societal CDMO team.”
About Societal CDMO
Societal CDMO is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
Read More
PHARMA TECH
Globenewswire | May 12, 2023
SERB Pharmaceuticals, a global specialty pharmaceutical company, and SFJ Pharmaceuticals, a global drug development company, announce that SERB has acquired exclusive US rights to the ticagrelor reversal agent bentracimab from SFJ.
Bentracimab is a novel, monoclonal antibody fragment designed to reverse the antiplatelet activity of ticagrelor. Ticagrelor, marketed by AstraZeneca as Brilinta®, is a reversible oral P2Y12 platelet inhibitor for patients who have suffered a heart attack or stroke, or who have acute coronary syndromes or coronary artery disease (CAD). Bentracimab, if approved by the FDA, could allow these patients to benefit from the antithrombotic effect of ticagrelor, preventing vascular events and reducing risk of death, while giving physicians a way to control bleeding in rare emergency situations such as surgery or a major bleeding event.
SFJ will remain responsible for the ongoing clinical trials of bentracimab and will work in collaboration with SERB to submit the Biologics License Application (BLA) to the US Food and Drug Administration (FDA), which they expect to file later this year.
Jeremie Urbain, Executive Chairman of SERB Pharmaceuticals, said: “The acquisition of bentracimab marks a significant step in our strategy to grow through investment in innovative, biologic products for critical care conditions and leverages our existing commercial and technical capabilities. We're excited to partner with SFJ, recognized leaders in late-stage drug development, to bring this life-saving medicine to healthcare professionals and the patients they treat.”
Robert DeBenedetto, Chief Executive Officer of SFJ, said: “We are pleased to partner with Jeremie and the entire SERB team on this important step to help advance bentracimab to patients. Bentracimab has recognized potential benefits and we have confidence that SFJ in collaboration with SERB will be able to expeditiously and efficiently see bentracimab through the approvals process by the US FDA.”
Bentracimab binds ticagrelor and its major active metabolite with high affinity and specificity. A prespecified interim analysis of the ongoing Phase 3 trial REVERSE-IT published in the New England Journal of Medicine Evidence demonstrated that bentracimab immediately and sustainably reversed the antiplatelet effects of ticagrelor, and was generally well tolerated, with only minor adverse events reported. In 2019 bentracimab received Breakthrough Therapy Designation from the FDA, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.
The companies did not disclose specific financial terms. Leopoldo Zambeletti acted as advisor for SFJ, and Evercore acted as advisor for SERB.
About SERB Pharmaceuticals
SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB has the broadest antidote portfolio in the world, including medical countermeasures for chemical, biological, radiological and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain. SERB operates in the US as BTG Pharmaceuticals.Learn more at https://SERB.com.
About SFJ Pharmaceuticals®
SFJ is a global drug development company, which provides a unique and highly customized clinical development partnering model for the world's top pharmaceutical and biotechnology companies. SFJ provides at-risk funding and the global clinical development management and oversight necessary for regulatory submission for some of the most promising drug development programs of Pharmaceutical and Biotechnology companies. SFJ's mission is to leverage its financial strength and global team of pharmaceutical development experts to accelerate the development of life-saving and life-enhancing drugs for the benefit of physicians and the patients they serve. www.sfj-pharma.com
Read More