Clinical research - Today Stories

Seeks to accelerate patient access to safe, effective, cutting-edge medical devices to diagnose and treat nervous systems disorders WILMINGTON, N.C.--(BUSINESS WIRE)-- The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been awarded a five-year contract to provide regulatory affairs support and related services for the Blueprint MedTech (BPMT) program, a new multi-institute/center initiative at the National Institutes of Health (NIH) supporting development of translational neurological devices. The BPMT program is a new NIH incubator with a collaborative reach across 11 NIH institutes, whose goal is to accelerate patient access to safe, effective, cutting-edge medical devices to diagnose and/or treat disorders of the nervous system.…

HS-001 consists of clusters of purified heart muscle cells derived from induced pluripotent stem cells (iPSCs). Clinical phase 1/2 study (LAPiS Study) will enrol 10 patients with advanced heart failure caused by ischaemic heart disease. Tokyo, Japan and Bagsværd, Denmark, 10 February 2023 – Heartseed Inc. (Heartseed) and Novo Nordisk A/S today announced that Heartseed has successfully dosed the first patient in a phase 1/2 clinical study (LAPiS Study) with HS-001 – an investigational cell therapy for heart failure. An independent safety evaluation committee has evaluated 4-week data on the patient, who lives with advanced heart failure and has given approval for the study to continue. Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood…

Study published today in Clinical Trials: Journal of the Society for Clinical Trials examined clinical trial diversity across 495 GSK trials involving over 100,000 participants Results demonstrate real-world disease epidemiology data—compared to the conventional standard of US Census data—may be better benchmark to ensure clinical trial enrolment reflects the populations affected by diseases GSK commits to applying insights from the study and collaborating with regulators, patients, academics and other biopharma companies to make meaningful progress on clinical trial diversity GSK plc (LSE/NYSE: GSK) today announced results from a retrospective study on clinical trial diversity, investigating the historical representation of US-based participants in GSK clinical trials. The study looked…

New collaboration leverages MyEyeDr.’s 850+ offices across the US to refer patients into ophthalmology and other therapeutic area clinical trials, expands Parexel’s Community Alliance Network to bring trials to patients where they are BOSTON and DURHAM, N.C., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, today announced a formal agreement with MyEyeDr., a leading vision healthcare organization, to refer its patients into existing and future ophthalmology clinical trials. Parexel and MyEyeDr. are currently collaborating on recruitment for a diabetic retinopathy clinical trial with future plans to expand into additional therapeutic areas such as endocrinolog…

Milton Keynes, UK. (6 December 2022) – Medical Research Network, a leading Clinical Trial Organization, was presented with the Queen’s Award for Enterprise, International Trade at a company meeting last night. The award, established by Her Majesty Queen Elizabeth in 1965, celebrates the country’s most exciting and innovative companies, and is Britain’s most prestigious business award. The International Trade category is awarded to companies who have achieved spectacular growth and commercial success overseas. The presentation took place at a company-wide meeting held at the Wyboston Lakes Resort, near the MRN headquarters in Milton Keynes. MRN executives from France, Germany, Spain, and Japan were there to watch the presentation in person, while executives from the MRN office in Chicago wa…

Data presented at CTAD 2022 confirm excellent clinical performance of ACI-35.030 vaccine candidate Based on this new clinical data, ACI-35.030 has been selected for further development representing significant progress for the anti-pTau vaccine candidate AC Immune vaccine portfolio targeting three hallmark proteins of neurodegenerative diseases now progressing through advanced clinical development Lausanne, Switzerland, November 30, 2022 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that based on the Phase 1b/2a interim data, ACI-35.030, a potential first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate, has been selected for further development. The ACI-35.030 anti-pTau vac…

Partnership between the University of Birmingham and Acticor Biotech will see patients with heart attacks treated with glenzocimab, a promising new class of drug for the first time. A potential new drug to improve the long-term outcomes for heart attack patients will be trialled in the UK. With the signing of a partnership between the University of Birmingham and Acticor Biotech, a new clinical trial called LIBERATE will take place in two acute care hospitals in the UK: the Queen Elizabeth Hospital, Birmingham and the Northern General Hospital, Sheffield. The randomised, double-blind Phase 2b LIBERATE study will recruit more than 200 patients to test the tolerance and the efficacy of glenzocimab 1000 mg, versus placebo, to reduce heart damage following a myocardial infarction (MI), commonl…

Bagsværd, Denmark, 22 November 2022 – Novo Nordisk today announced plans to invest 5.4 bn Danish kroner in the expansion of existing facilities in Bagsværd. The plans also include the construction of a new plant located in extension of the existing facilities. The investment will establish additional capacity in R&D for manufacturing of active pharmaceutical ingredients (API) to supply our global clinical trials. These expansions will provide capacity for developing Novo Nordisk’s future oral and injectable product portfolio. “This investment in expanding our clinical API capacity in Bagsværd is an important step to ensure the continuous progress of our development pipeline. Increasing our API capacity in R&D will be a key enabler in bringing new innovations to the market, and meet…

London, U.K., 17 November 2022: Velocity Clinical Research (“Velocity”), the leading integrated research site organisation, today announces its expansion into the U.K. with the acquisition of multi-site company Egin Research. Velocity is the first US-based clinical research sites business to expand into Europe, bringing its total number of dedicated research locations to 42. The addition of Egin Research’s two sites increases Velocity’s European site footprint to three, after its first European purchase in Hamburg, Germany in July 2022 and further growth expected over the next 12 months. Dominic Clavell, Executive Vice President, Europe, said, “The size and importance of the UK market for clinical research cannot be underestimated. There is a focus on clinical trial regulation reform in a…

$97 million investment enhances bioanalytical services, helping pharma and biotech customers accelerate drug development WILMINGTON, N.C.--(BUSINESS WIRE)-- Thermo Fisher Scientific, the world leader in serving science, today expanded its clinical research operations with the opening of a state-of-the art bioanalytical lab in Richmond, Virginia. The new unit will support increasing demand across biopharma for consistent, high-quality laboratory services to accelerate drug development. The 59,000-square-foot facility is part of the previously announced $97 million investment by the company to expand its bioanalytical laboratory operations in Richmond and add more than 500 jobs over the next three years. The current laboratory services operation in Richmond, which Thermo Fisher acquired thro…

Quanticate, a global data-focused clinical research organisation (CRO), has partnered with leading cancer research organisation, Cancer Research UK, to launch the DETERMINE study which will test a range of therapies specifically targeting key genetic changes in cancer cells.  The first of its kind in the UK, the DETERMINE study will enrol patients with rare cancers, and aim to find out whether existing licensed drugs could be used to treat their type of cancer. Cohorts will be formed of patients who have an identifiable genetic alteration in their cancer that can be targeted by treatments already approved for use in other cancer types.  Quanticate has been working with Cancer Research UK’s Centre for Drug Development to ensure the statistical design of the study is optimised.  “The study w…

Opportunity to provide digital data and decentralized trial services for multi-institutional cancer trials led by NCI-supported organizations WILMINGTON, N.C.--(BUSINESS WIRE)-- The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been awarded a 10-year Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract by the National Cancer Institute (NCI), part of the National Institutes of Health, to support NCI’s Cancer Trials Support Unit (CTSU). As part of the award, the PPD clinical research business will have the opportunity to coordinate the resources and processes necessary to identify, deploy, support and maintain a platform for the collection and migration of electronic patient-reported outcomes (ePROs) and other patient-generated…

Key leadership appointments focused on enhancing connections and collaboration to drive Innovation across the next-generation delivery of clinical trials and fuel more integrated, therapeutically-focused solutions for patients BOSTON and DURHAM, N.C., Sept. 14, 2022 (GLOBE NEWSWIRE) -- Parexel, a leading global clinical research organization (CRO), today announced the promotions of Peyton Howell to the newly-created role of Chief Operating and Growth Officer and Amy McKee, MD, to Chief Medical Officer and Global Head, Oncology Center of Excellence. These moves are designed to strengthen the company’s medical and scientific focus and support its continued record growth through closer alignment of all aspects of strategy, sales and delivery to delight customers, build repeat business and lea…

25-year industry veteran and Biotech business leader recognized among the most inspiring people in life sciences BOSTON and DURHAM, N.C., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Parexel, a leading global clinical research organization (CRO) focused on development and delivery of innovative new therapies to advance patient health, today announced Executive Vice President and Global Head of Biotech Jim Anthony has been named to the PharmaVOICE 100 list of the most inspiring people in the life sciences industry. Mr. Anthony was recognized for his outstanding leadership, ready-for-anything attitude and relationship-building prowess to grow Parexel’s Biotech business with a Patients-First approach. His leadership has been transformational to the company’s growth while contributing to innovative new…

Marking its 20th global recipient, the grant program supports next-generation sequencing-based research to explore new and expanded applications for molecular testing CARLSBAD, Calif., August 01, 2022 - As part of its continued commitment to expand the benefits of next-generation sequencing (NGS), Thermo Fisher Scientific is now accepting submissions for the fifth round of the Oncomine Clinical Research Grant program. The program supports clinical and translational research that advances the use of genomic testing to unlock the promise of precision medicine for more cancer patients. The program awards independent clinical research teams with financial support worth up to $200,000 in reagents and general funding. Since its introduction in 2020, the Oncomine Clinical Research Grant program…

CRO gains access to genetic testing data, aims to improve global research with enhanced data insights and faster patient recruitment for rare disease studies Research Triangle Park, N.C. – July 12, 2022 –Worldwide Clinical Trials, Inc. (Worldwide), the industry’s leading global, midsize, full-service contract research organization (CRO), today announced its strategic partnership with Invitae, a leading medical genetics company. The partnership makes Worldwide the first CRO to use Invitae’s Explorer tool – part of its real-world data platform that enables access to aggregated genetic testing results. Around the world, 300 million people have a rare disease, and 72 percent of those diseases have genetic origins (source). This partnership underscores Worldwide’s global leadership in rare dise…

Interim data presented at the European Academy of Neurology 2022 shows that 54.7% of patients in the study had their monthly-migraine-days reduced by 50% or more over the six-month period from the start of treatment. Teva Pharmaceuticals Europe B.V. today announces promising interim results from its Pan-European Real World study (PEARL), presented for the first time at the European Academy of Neurology (EAN) Congress in Vienna, Austria. The two-year Pan-European Real World (PEARL) prospective, observational study of AJOVY® (fremanezumab), looks at its effectiveness in patients with chronic migraine or episodic migraine, and is an ongoing study sponsored by Teva Pharmaceuticals Europe BV.[i]  These findings further offer insight into the treatment of migraine in real-world clinical practice…

Scientific Laboratory Supplies (SLS) – the leading supplier of equipment, chemicals and consumables for laboratory use in the UK – has announced the acquisition of two businesses, Gem Scientific and Northern Balance, to expand its product and service offerings. Both companies will continue to operate as independent entities and retain all employees, whilst harnessing SLS’s business support and infrastructure to benefit all parties, stakeholders and customers.   Gem Scientific is a laboratory equipment distributor based in West Yorkshire, supplying high quality products – including hygiene testing devices and consumables – to sectors such as the food and beverage industry. This acquisition will help to strengthen both brands in this field, giving customers greater access to a wider range of…

Alliances with CVS Health and Javara further embed clinical research into the community healthcare setting, expanding access to patient populations across the U.S. to increase diversity in clinical trials BOSTON, and Durham, N.C., June 16, 2022 (GLOBE NEWSWIRE) -- Parexel, a leading global clinical research organization (CRO), today announced the launch of its Community Alliance Network, a novel program further integrating clinical research into the community healthcare setting to better serve patients and in turn create further opportunity for increased diversity in clinical trials. CVS Health®, the leading health care solutions company, and Javara, the leading Integrated Research Organization, have joined the network as inaugural members, opening the door to community-based research site…

Leading contract research organisation (CRO) Cellomatics Biosciences has moved into new purpose-built premises in Nottingham in the wake of rising demand for its bespoke preclinical and early drug discovery phase laboratory services. The company’s new facilities in Colwick, Nottingham represent a three-fold increase in the company’s footprint, allowing room for further expansion. The purpose-built facility is an independent building covering approximately 5,500 sq ft of space across two levels. The ground floor is dedicated to laboratory facilities, whilst the first floor provides scientific write-up space, offices, and meeting rooms. The new laboratories are equipped with state-of-the-art imaging and analysis equipment and Class ll biological safety cabinets, fridges, freezers, and CO2 in…