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
NTT DOCOMO BUSINESS and Chile’s State-owned Copper Company CODELCO Launch a Study and Proof of Concept Aimed at Improving the Efficiency of Remote Copper Mine Operations Using IOWN ® APN6.8.2026 07:30:00 EEST | Press release
NTT DOCOMO BUSINESS, Inc. (formerly NTT Communications Corporation) has launched a study and proof of concept jointly with Corporación Nacional del Cobre de Chile (CODELCO) to progress remote operations at CODELCO’s copper mines using an IOWN® All-Photonics Network (APN).1 This initiative is part of a research project commissioned by Japan’s Ministry of Internal Affairs and Communications.2 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806845222/en/ Conceptual Diagram of the Demonstration To address operational challenges faced by CODELCO’s copper mines, the initiative will connect a copper mine and a remote operations center—approximately 1,500 km apart—via an IOWN APN. It will assess the feasibility of remotely operating heavy machinery using high-capacity, low-latency communication links, enhancing monitoring operations through high-definition video, and implementing a remote operations model. 1. Background Chile is o
FPT Named an OpenAI Select Partner6.8.2026 03:00:00 EEST | Press release
Global IT corporation FPT today announced that it has been named an OpenAI Select Partner within the OpenAI Partner Network. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260805503787/en/ FPT Named an OpenAI Select Partner The OpenAI Partner Network is a global program for partners to build, sell, and deliver AI solutions with OpenAI. It brings together partners with deep industry expertise, delivery capabilities, and customer relationships while equipping them with resources, enablement, and support to help enterprises adopt OpenAI frontier models and products and turn them into measurable impact. As an OpenAI Select Partner, FPT will continue working with OpenAI to help organizations build, deploy, and scale AI solutions responsibly and effectively. This work will help organizations get more useful work from every token and stronger performance per dollar with GPT‑5.6, while using ChatGPT Work to turn ambitious goals into
U.S. FDA Approves Takeda’s ORZEYFUL™ (oveporexton), the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 16.8.2026 01:10:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. As a first-in-class orexin treatment, ORZEYFUL is the only medicine indicated in the U.S. to treat the disease holistically rather than individual symptoms. “The FDA approval of ORZEYFUL marks a new chapter for the narcolepsy type 1 community, as we introduce an entirely new class of medicine that will potentially redefine how this disease is managed and howpeople feel on treatment,” said Julie Kim, president and chief executive officer of Takeda. “We are proud to have discovered and developed this orexin treatment innovation and will bring it to adults living with NT1 as quickly as possible.” NT1 is a rare, chronic neurological disease d
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.8.2026 23:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to fourteen newly hired non-executive employees. The equity awards were granted on August 3, 2026 and consisted of options to purchase an aggregate of 139,355 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 66,300 shares. The options have an exercise price per share equal to $11.25, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted
Clinilabs Announces Medical Leadership Appointments5.8.2026 17:05:00 EEST | Press release
Clinilabs (“Clinilabs LLC”), a global, full-service contract research organization (CRO) specializing in central nervous system (CNS) drug and device development, today announced the appointments of Bob Dagher, M.D., as Chief Medical Officer and Waqar Ahmed Siddiqui, M.D., as Principal Investigator of the Company’s Eatontown, New Jersey Clinical Research Unit (CRU). Dr. Dagher will provide strategic and medical leadership across the organization, while Dr. Siddiqui will lead the execution of research projects at the Company’s CRU. Together, they will support the design, development, and execution of clinical programs for pharmaceutical, biotechnology, and medical device sponsors advancing innovative therapies for psychiatric, neurological, substance use, and rare CNS disorders. “Clinilabs has earned the trust of sponsors by combining deep scientific expertise, medical leadership, and operational excellence with a track record of execution from first-in-human studies through regulatory
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