Veristat Congratulates HIPRA for EMA Approval of Its BIMERVAX® COVID-19 Vaccine
25.4.2023 10:04:00 EEST | Business Wire | Press release
Veristat, a scientific-minded, global clinical research organization (CRO), today congratulated HIPRA for marketing authorization by the European Medicines Agency (EMA) and European Commission of BIMERVAX®, a bivalent adjuvanted vaccine based on the Beta and Alpha variants of SARS-CoV-2 and indicated as a booster dose for people over 16 years of age. BIMERVAX® is the first bivalent recombinant protein vaccine against the virus to be authorized in the European Union and the first human health vaccine to be designed and developed in Spain.
HIPRA worked tirelessly to support the development of a technologically agile platform, allowing for the inclusion of more than one variant in a single active substance, previously not achievable in the designs of other vaccines approved in the European Union. Veristat’s global teams collaborated closely with HIPRA to establish a comprehensive strategy to demonstrate the benefits of the next-generation COVID-19 vaccine in adult populations. HIPRA engaged Veristat across clinical studies, encompassing the planning and implementation of the pertinent scientific, operational, and biometrics aspects of the clinical trials.
“Clinical trial activity remains steady in new vaccine development, as COVID-19 continues to impart tremendous health and societal impact on our world,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “Maintaining vaccine options for all populations, especially immunocompromised populations, remains vitally important. Congratulations to the entire HIPRA team for putting your tremendous talents and technologies to work in helping to safeguard society further from the often devastating consequences of COVID-19. You have set a new standard for what it means to be a true partner. Veristat is proud to have used our bold thinking and scientific expertise to support HIPRA in the clinical trials for BIMERVAX®.”
Around the globe, health authorities, governments, and biopharmaceutical companies continue their efforts to fast-track the development of therapies or platforms to prevent, diagnose, and treat widespread illness due to COVID-19 and its variants. Veristat’s expertise comes from planning or conducting more than 70 COVID-19 projects for a broad range of therapies, including anti-inflammatories, antivirals, antiseptics sprays, cannabinoids, advanced therapies, probiotics, monoclonal antibodies, and vaccines.
“We are thrilled with the results of the studies completed for BIMERVAX® and we are confident that it will play an important role in vaccination plans,” stated HIPRA. "We would extend our heartiest thank you to the entire Veristat team who has worked so diligently. HIPRA is gratified to know that the efforts and commitment of the teams have resulted in an approved vaccine to advance protection against the virus.”
About Veristat
Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval and commercialization. With more than 28 years of experience in clinical trial planning and execution, Veristat is equipped to support any development program.
Veristat's focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. Every day, we apply this knowledge base to solve any program’s clinical, regulatory, statistical, data, or operational challenges, from the simplest to the most complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving patients’ lives.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230425005356/en/
Contact information
Lauren L. Brennan, Vice President of Marketing, Veristat
media@veristat.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
From Network Automation to Agentic NetOps: NetBrain Sets the Standard for Deploying AI in Network Operations29.5.2026 16:00:00 EEST | Press release
NetBrain Technologies, Inc. today announced major new platform features that advance Agentic NetOps from an emerging category to operational reality. NetBrain's clients are already deploying agents that are diagnosing and remediating issues across complex multi-vendor enterprise networks. These new features further extend the platform with new agent tooling, cross-domain context, and open interfaces for the broader agentic enterprise. Early customer outcomes show the magnitude of the shift: A leading health insurer used NetBrain's Deep Diagnosis agent to diagnose and resolve a weeks old VPN connectivity issue in under five minutes. A large manufacturer resolved a critical device issue with a single prompt, isolating the root cause across the network path in under 20 minutes, saving hundreds of hours of engineer time, shrinking MTTR by more than 95%. A global telecommunications firm found NetBrain's context-grounded agents outperformed a stand-alone frontier LLM on a persistent firewall
Adtran resolves long-running patent litigation, reinforcing commitment to defend innovation29.5.2026 15:00:00 EEST | Press release
Adtran today announced it has resolved a patent litigation matter, resulting in a full settlement and dismissal of all claims with prejudice. The case, initiated in 2020 by a non-practicing entity asserting five patents, was transferred to the US District Court for the Northern District of Alabama in 2021 following a successful motion by Adtran. Adtran subsequently filed counterclaims, including bad-faith patent assertion under Alabama statutory law. The settlement includes payment to Adtran to resolve its counterclaims. Terms of the agreement remain confidential. “This outcome reflects a disciplined and consistent approach to protecting our innovation and our customers,” said Justin Ferguson, SVP and general counsel at Adtran. “We take all claims seriously, but we will not hesitate to defend ourselves when assertions lack merit. Situations like this place unnecessary strain on technology providers and divert resources from advancing networks and services. By advancing our counterclaim
Meiji Seika Pharma Invests in GHIC’s Global Health Security Fund29.5.2026 14:00:00 EEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan; President and Representative Director: Toshiaki Nagasato) today announced that it has committed to invest in the Global Health Security Fund (GHSF), which is sponsored by Global Health Investment Corporation (GHIC), a New York-based nonprofit organization. Through this investment, Meiji Seika Pharma will support the acceleration of innovations addressing critical global health challenges, including pandemic preparedness and antimicrobial resistance (AMR). GHIC is a mission‑driven nonprofit organization that deploys private investment strategies to generate both global health impact and financial returns. GHIC recently closed its second fund in GHSF. With more than a decade of experience investing in the field of infectious disease, GHIC has contributed to addressing major global health challenges. Its portfolio companies have successfully commercialized more than a dozen products, collectively reaching over 600 million people wo
IFF Enters Into Agreement to Sell Its Food Ingredients Business to CVC29.5.2026 13:50:00 EEST | Press release
IFF (NYSE: IFF), a global leader in flavors, fragrances, food ingredients, and health and biosciences, today announced that it has entered into an agreement to sell its Food Ingredients business to funds advised by CVC Capital Partners, a leading global private markets manager, in a transaction that values the business at approximately $4.3 billion, representing an enterprise value-to-EBITDA multiple of approximately 10x. As part of the transaction, IFF has chosen to retain an approximately 10% minority equity interest in the business, or approximately $200 million, permitting continued collaboration and cooperation between IFF and Food Ingredients and allowing IFF and its shareholders to participate in future value creation under its new ownership. The transaction marks a significant step in IFF’s portfolio transformation and is expected to strengthen the company’s focus on its innovation-driven businesses: Taste, Scent, and Health & Biosciences. Following the transaction, IFF will be
BeOne Medicines Establishes Standard for Long-Term Disease Control in CLL with BRUKINSA 78-Month Data at ASCO 202629.5.2026 13:00:00 EEST | Press release
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, is advancing the treatment paradigm in chronic lymphocytic leukemia (CLL) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. With extensive long-term follow-up, the SEQUOIA study of BRUKINSA® (zanubrutinib) reinforces its role as the foundational BTK inhibitor, showing sustained disease control over years of therapy. These findings are further supported by real-world evidence across three large analyses encompassing more than 250,000 patients, underscoring consistent effectiveness and safety in clinical practice. Additionally, BEQALZI™ (sonrotoclax), which was recently approved by the U.S. Food and Drug Administration, and its development in combination with BRUKINSA (ZS) highlight the potential for next-generation, time-limited treatment approaches in CLL. Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said: “CLL is a disease patients live with
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom