Clinical research - Today Stories

WILMINGTON, N.C., April 21, 2022 - The PPD clinical research business of Thermo Fisher Scientific was named "Best Contract Research Organization" at the 15th annual Vaccine Industry Excellence (ViE) Awards during the 2022 World Vaccine Congress, recognizing its success in helping customers develop safe and effective vaccines to improve health and save lives. The honor marks the business' second consecutive year earning "Best CRO" at the ViE Awards and follows recognition at the Citeline Awards as "Clinical Research Team of the Year" with Moderna, whose pioneering mRNA vaccine for COVID has been administered to hundreds of millions globally. With more than 30 years of commercial and government vaccine experience, the business has conducted vaccine studies in more than 90 countries and works…

Mobile research – sites an innovative decentralized trial solution – ease barriers to patient participation, improve trial enrollment WILMINGTON, N.C., April 19, 2022 - The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, and Matrix Clinical Trials, a Matrix Medical Network offering, are collaborating to bring clinical trials to patients with an innovative decentralized clinical trial (DCT) solution. The business is deploying state-of-the-art Matrix mobile research sites and expert clinical staff across the U.S. to help identify, recruit and retain trial participants, while ensuring a positive patient experience. At the same time, the two companies are exploring opportunities to expand the collaboration to additional geographies. Therm…

The Citeline Award recognizes the COVE study, Moderna's Phase III vaccine trial that enrolled more than 30,000 participants across the U.S. WILMINGTON, N.C., April 14, 2022 - The PPD clinical research business of Thermo Fisher Scientific and Moderna, whose pioneering mRNA vaccine for COVID has been administered to hundreds of millions globally, were named "Clinical Research Team of the Year" during the 2021 Citeline Awards. As Moderna's clinical research organization partner, the PPD team, now part of Thermo Fisher, supported Moderna's mRNA-1273-P301 vaccine trials, including its pivotal Phase III COVE study. The study enrolled more than 30,000 participants, ages 18 and older, across 99 U.S. sites in 12 weeks in the summer/fall of 2020. The Citeline Award for "Clinical Research Team of t…

Spin-out from the University of Edinburgh commercialising a decade of drug discovery research on kynurenine 3-monooxygenase (KMO), a pivotal enzyme in the kynurenine pathway of tryptophan metabolism Kynos programmes are focused on three key areas: in critical illness post-surgery; in conditions driven by inflammation; and in cancers where inflammation is preventing the immune system from fighting back £9m financing made up of £6.5m equity financing led by Epidarex Capital, together with IP Group and Scottish Enterprise, alongside £2.5m Innovate UK grant funding for a Phase 1 clinical trial of lead KMO inhibitor Innovative pipeline of first-in-class KMO inhibitors exclusively licensed from the University of Edinburgh after a co-development programme with GSK Company led by industry-experie…

Agreement brings complementary capabilities in clinical, regulatory and scientific affairs for clients in key markets Frankfurt, Germany – 8 January 2022: PharmaLex Group, a leading provider of specialized services for the pharma, biotech and medtech industries worldwide, has announced a merger agreement with Ascent Development Services, a Japan-based leader in enabling the integration of  Asia into global pharmaceutical product development. Founded in 2017, Ascent’s team of experts work with emerging biopharma companies to understand and overcome differences in medical practice, culture and language in order to achieve the optimal strategic and operational integration of Asia into global drug development.  Headquartered in Tokyo, Ascent employs staff across Asia, including China, Korea, M…

EQT Private Equity and Goldman Sachs Asset Management committed to supporting Parexel’s Patients-First focus, track record of clinical excellence and dedication to quality Newly-appointed Board of Directors brings vast experience across life sciences, digital transformation and innovation to guide next phase of transformational journey EQT Private Equity and Goldman Sachs Asset Management to back existing management team led by CEO Jamie Macdonald BOSTON and Durham, N.C. Nov. 15, 2021 — Parexel, a leading global clinical research organization (CRO) focused on development and delivery of innovative new therapies to advance patient health, today announced the completion of its acquisition by EQT IX fund (“EQT Private Equity”) and funds managed by the Private Equity business within Goldman…

Ki-CONNECT collaboration seeks to offer clinical trial benefits to patients and the pharmaceutical industry BOSTON and Durham, N.C. Oct. 20, 2021 — Parexel, a leading global clinical research organization (CRO) focused on development and delivery of innovative new therapies to advance patient health, and Kyoto University Hospital today announced a strategic alliance aimed at providing more opportunities for clinical research and producing efficient and productive ways of supporting clinical studies. As part of Parexel’s Alliance Site network — consisting of more than 500 sites and over 17,000 investigators across the globe accelerating access to and enrollment of patient populations for clinical trials — Kyoto University Hospital will share their therapeutic expertise and opportunities to…

Melbourne (Australia) – 18 August 2021. Telix announces pan-cancer clinical collaboration with Merck KGaA, Darmstadt, Germany. Telix today announces that it has entered into a pan-cancer clinical collaboration with Merck KGaA, Darmstadt, Germany (Merck), to conduct combination studies with one of Merck’s investigational proprietary DNA Damage Response Inhibitor (DDRi) molecules in combination with each of Telix’s TLX591 (177Lu-rosopatamab) and TLX250 (177Lu-girentuximab) molecularly targeted radiation (MTR) therapeutic programs. This clinical collaboration builds on the success of a strategic research collaboration agreement between Telix and Merck announced in August 2019. TLX591 and TLX250 are late-stage products in development for prostate and renal cancer therapy, respectively. Under t…

Vancouver, Canada. August 9, 2021 – NervGen Pharma Corp. (TSX-V: NGEN) (OTCQX: NGENF) (“NervGen” or the “Company”), a clinical stage biotech company dedicated to creating innovative solutions for the treatment of nervous system damage, announced today it has entered into a research collaboration with Dr. Ksenia Kastanenka of Massachusetts General Hospital (MGH) to study the effects of NervGen’s lead compound, NVG-291, in validated animal models of Alzheimer’s disease. “We are very happy to be collaborating with Massachusetts General Hospital and Dr. Kastanenka to study the mechanism of our technology in an Alzheimer’s disease model,” stated Dr. Daniel Mikol, NervGen’s Chief Medical Officer. “As the original and largest teaching hospital for Harvard University, and one of the largest funded…

Collaboration seeks to obtain direct insights from patients to improve clinical trial accessibility, drive efficiency  Parexel, a leading global clinical research organization (CRO) focused on development and delivery of innovative new therapies to advance patient health, today announced an innovative partnership with Cancer Hospital Chinese Academy of Medical Sciences (CHCAMS) to develop patient-centric protocol designs and methodologies for decentralized clinical trials in China. The collaboration will also include quantitative research to improve the clinical trial experience of oncology patients. “We are honored to be partnering with CHCAMS,” said Vicky Hsu, Corporate Vice President, Greater China Region Head and Head of Asia/Pacific Biotech Operations for Parexel. “The Cancer Hospital…

The company employs real-world data and evidence to accelerate research through targeted site and patient recruitment strategies Based on its recent analysis of the global clinical research organization (CRO) market, Frost & Sullivan recognizes leading global CRO Parexel  with the 2021 Global Enabling Technology Leadership Award. Parexel streamlines clients’ clinical development programs, enabling them to navigate market, regulatory, and patient access-related challenges seamlessly. Leveraging a leading suite of end-to-end biopharmaceutical development services covering patient-focused clinical trial design and decentralized clinical trial (DCT) strategies, the company has helped develop 198 of the 200 top-selling biopharmaceuticals in the market. “Parexel employs a dedicated project t…

The EMPEROR-Preserved Phase III trial met its primary endpoint and demonstrated significant risk reduction with empagliflozin for the composite of cardiovascular death or hospitalization for heart failure in patients with heart failure with preserved ejection fraction (HFpEF) HFpEF has been classified as “the single largest unmet need in cardiovascular medicine”1 based on prevalence, poor outcomes and the absence of clinically proven therapies to date2 With approval, empagliflozin would become the first and only clinically proven therapy to improve outcomes for the full spectrum of heart failure patients regardless of ejection fraction  The EMPEROR-Preserved Phase III trial met its primary endpoint, establishing empagliflozin as the first and only thera…

Trial will evaluate potential of next generation of influenza vaccines with combined mRNA technology and flu vaccine development expertise Positive preclinical safety and immunogenicity data for mRNA influenza vaccine candidates support initiation of Phase 1 clinical trial Interim data anticipated by the end of 2021; outcomes from this clinical trial will inform next steps of our mRNA-based influenza vaccine program and strategy Sanofi Pasteur, the vaccines global business unit of Sanofi and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, have initiated a Phase 1 clinical trial evaluating an mRNA-based investigational vaccine against seasonal influenza. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate co…

Q2 Solutions, a wholly-owned subsidiary of IQVIA and a leading clinical trial laboratory services organization, today announced a transformative collaboration with Tasso Inc., a pioneer in clinical-grade, at-home, patient-centered blood testing, to develop diagnostic tests used in decentralized (virtual) clinical trials. These new laboratory-developed tests will use Tasso’s devices, enabling patients to collect their own blood using a virtually painless process from anywhere at any time. “The current COVID-19 pandemic has created a surge in demand for more virtual clinical trials and remote patient monitoring applications,” said Ben Casavant, PhD, CEO and Co-founder of Tasso. “Tasso is now poised to accelerate this paradigm shift in patient care through our clinical-grade and convenient bl…

Two-stage design will evaluate vaccine formulations targeting original D.614 virus as well as B.1.351 variant, in diverse geographies with multiple circulating variants A booster study program will begin in the coming weeks to complement Phase 3 trial Pending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved in Q4 2021 PARIS and LONDON – May 27, 2021 – Today, Sanofi and GSK started enrollment in their Phase 3 clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa, and Latin America. The prim…

COVID-19 made 2020 the most challenging year in decades – but clinical researchers rose to the challenge. Thanks to clinical trials, millions of doses of life-saving vaccines have been developed and administered around the world, giving hope for a better year ahead. Hope. That’s what clinical researchers provide. Every day, they rise to a new challenge and give patients and families hope for a healthier, more promising tomorrow. On this Clinical Trials Day, the Association of Clinical Research Professionals (ACRP) thanks clinical researchers around the world for continuing to rise to the challenge and give us hope. Hope in the battle against infectious disease. Hope in the battle against cancer. Hope in the battle against anything that challenges our pursuit of a better tomorrow. Why May 2…

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups High immune response after a single dose in patients with prior infection shows strong booster potential Global Phase 3 study expected to start in the coming weeks The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers. A global pivotal Phase 3 study is expected to start in the coming weeks. The Phase 2 interim results showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses, with acceptable tolerab…

- A new, first-of-its-kind study known as TAP-CHF leverages expertise across Abbott's cardiovascular portfolio to optimize treatment for patients suffering from both AFib and heart failure - The trial will utilize Abbott technology including cardiac ablation and sensors to monitor for both pulmonary artery pressure and abnormal heartbeats - Historically, treating patients with both AFib and heart failure has been challenging, with few effective treatments or options to adequately manage both conditions simultaneously Abbott (NYSE: ABT) today announced a new trial focused on improving the treatment for people simultaneously battling both atrial fibrillation (AFib) and heart failure. The first-of-its-kind trial aims to provide new insights into more effective treatment for patients with AFib…

PREVENT-19 clinical trial expanded to assess the efficacy, safety and immunogenicity of NVX-CoV2373 for the prevention of COVID-19 in up to 3,000 12-17-year-old adolescents President of Research and Development, Gregory Glenn, M.D., to provide update regarding the additional trial arm during World Vaccine Congress Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated a pediatric expansion of its Phase 3 clinical trial for NVX-CoV2373, the company's recombinant protein vaccine candidate against COVID-19. The additional arm of the ongoing PREVENT-19 pivotal trial will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents aged 12-17 across up to 75…

Australia has the highest age-standardized incidence rate for all cancers in the world and one of the countries with substantial cancer screening programs. Against this backdrop, several pharma companies are conducting clinical trials related to cancer drugs in the country. Among these, Roche continues to be a key player with the highest number of clinical trials in oncology indications, says GlobalData, a leading data and analytics company.   Ms. Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “Despite high incidence rates, mortality rate is low in Australia due to early and extensive screening. Owing to the government’s greater focus on managing cancer, patients can gain access to good diagnostic facilities, healthcare and novel cancer therapies. Participation in clinical trials e…