Clinical research - Today Stories

BASINGSTOKE, June 15, 2020 – Eli Lilly and Company announced today that the first patient has been enrolled in a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with COVID-19. Baricitinib, is approved in 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA). Lilly expects to enroll 400 patients in the trial, with data expected in the next few months. The study will be conducted in the U.S., U.K., Europe and Latin America and includes patients hospitalized with SARS-CoV- 2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry. In COVID-1…

NEW BRUNSWICK, N.J., June 10, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, “Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Simulta…

The House of Lords International Agreements Sub-Committee has today launched its first call for evidence, seeking views on the ongoing UK-US trade negotiations. The committee is seeking evidence on the full range of areas being negotiated with the US, with an initial focus on agriculture and food safety, healthcare and drug pricing, and digital trade and services. The committee is asking for submissions of written evidence to be received by Friday 26 June, but the call for evidence will remain open throughout the negotiations. Lord Goldsmith, Chairman of the Internaional Agreements Sub-Committee, said: “The International Agreements Sub-Committee has been established to scrutinise how the Government negotiates new international agreements for a post-Brexit UK. This includes new trade deals.…

JUNE 1 2020, 10:00 KST, INCHEON, KOREA – Celltrion Group today announced positive pre-clinical results for its COVID-19 antiviral antibody treatment, with data demonstrating a 100-fold reduction in the viral load of SARS-CoV-2, the virus causing COVID-19. The treatment was also able to show improvement in lung lesions to a normal activity level in animal models. The pre-clinical study was conducted in an animal model in collaboration with one of the Korean National Universities, Chungbuk National University College of Medicine. The trial set out to assess the efficacy of two dosage amounts (low and high) for the antiviral antibody treatment. In comparison to the placebo-controlled group, the research team observed improved recovery in terms of clinical symptom scores such as runny nose, co…

SAN FRANCISCO, May 18, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the publication of research findings from the company’s efforts to develop therapeutics for COVID-19 in the May 18, 2020 issue of the journal Nature. The paper, entitled “Cross-neutralization of SARS-CoV and SARS-CoV2 by a human monoclonal antibody” (Pinto, et al., Nature), details the identification and characterization of S309, an antibody isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003, which has been shown to prevent SARS-CoV-2 live virus infection of cells. Vir is advancing two clinical development candidates based on the S309 antibody as potential therapeutics for COVID-19, VIR-7831 and VIR-7832, in collaboration with GlaxoSmithKline plc (L…

PLYMOUTH MEETING, Pa., May 20, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO) today announced the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2. The study was published in the peer-reviewed journal Nature Communications titled, "Immunogenicity of a DNA vaccine candidate for COVID-19" by INOVIO scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine. Dr. Kate Broderick, INOVIO's Senior Vice President of R&D and the Team Lead for COVID-19 vaccine development, said, "These positive preclinical results from our COVID-19 DNA vaccine (INO-4800) not only highlight the potency of our D…

Clinical Trials Day is a well-deserved ‘time out’ to recognize the people who conduct clinical trials and to say “thanks” for what they do every day to improve public health. This day of celebration also provides our community with a unique opportunity to raise awareness of clinical trials – and of clinical research as a career option – among the greater public. Clinical Trials Day is celebrated around the world in May to recognize the day that James Lind started what is often considered the first randomized clinical trial aboard a ship on May 20, 1747. According to some historians, The HMS Salisbury of Britain’s Royal Navy fleet was patrolling the English Channel at a time when scurvy is thought to have killed more British seamen than French and Spanish arms. Aboard this ship, surgeon ma…

The UK has joined the US, Europe and the World Health Organisation by including loss of smell or taste as an officially recognised symptom of Covid-19 – thanks in part to an international research project involving Professor Carl Philpott at the University of East Anglia. Led by an international delegation, the Global Consortium for Chemosensory Research (GCCR) survey was launched in response to anecdotal reports of smell and taste loss in people who have tested positive for Covid-19. UEA smell expert Prof Carl Philpot, from Norwich Medical School, is one of the research group’s members. He has also been surveying local hospital workers during the pandemic. He said: “Our group of international smell and taste researchers united to study how, when and why people are experiencing a loss of s…

University of East Anglia researchers are launching a new study to see how Covid-19 and lockdown are affecting people with bone, joint and muscle pain. Their previous research has revealed the challenges and poor health outcomes caused by social isolation and loneliness for people with conditions like osteoarthritis, rheumatoid arthritis, lower back pain, osteoporosis and fibromyalgia. Now, the team are looking for people with bone, joint and muscle pain to take part in a 12-week online survey to see how they are coping at this difficult time of coronavirus self-isolation. The study is being led by Dr Toby Smith, from UEA’s School of Health Sciences, and Prof Alex MacGregor, from UEA’s Norwich Medical School. Dr Smith said: “Bone, joint and muscle pain is a major cause of disability for pe…

-       Novel Carbohydrate Binding Modules (mCBMs) block entry into airway cells for a range of viruses causing respiratory tract infections -       Results show Pneumagen’s mCBMs demonstrate activity against coronaviruses   28th April 2020 – St Andrews, Scotland – Pneumagen Ltd, a University of St Andrews spinout, focused on treating infectious disease and oncology by targeting the human glycome, today announced results from three separate in vitro studies into preventing coronavirus infections including SARS-CoV-2 infection the cause of COVID-19 using Neumifil™ and other first-in-class multivalent Carbohydrate Binding Modules (mCBMs), generated using its proprietary GlycoTarge™ platform. Working closely with Public Health England’s Porton facility, and separately the University of Glasgo…

PARIS and TARRYTOWN, N.Y. – March 30, 2020 – The first patient outside of the U.S. has been treated as part of a global clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the United States – all countries that have been impacted by COVID-19. This is the second multi-center, double-blind, Phase 2/3 trial as part of the Kevzara COVID-19 program, and the companies are continuing to work with health authorities around the world to secure initiation at additional sites. This follows Sanofi and Regeneron’s announcement earlier this month of the initiation of the first trial, which is U.S.-based. “Sanofi and Regeneron are relentlessly working to rapi…

PharmiWeb Ltd, owners of Europe's largest Pharma Job Board, are pleased to announce that they have launched their latest job board for Pharma and Life Science Jobs in Australasia. The new job board will focus on the Pharma, Life Sciences & Medical Devices sector in Australasia and will give the region's job seekers a new dedicated website for their job hunting.    The site is built upon on the well-established Madgex job board platform already used by many major organisations globally, and ensures it will be continually updated with new technological advances such as AI and machine learning and new features that will help candidates find the best jobs and recruiters find the best candidates. For life science candidates, it provides the perfect platform to help them with their career de…

London, United Kingdom, Tuesday 10 March - George Health, a profit-for-purpose company, today announces £27 million / $35 million of new financing to accelerate the commercialisation of affordable drug treatments and technologies for some of the world’s biggest killers. This funding round was led by Bupa Australia, Federation Asset Management and the Australian Government-backed Medical Research Commercialisation Fund Biomedical Translation Fund (MRCF BTF), managed by Brandon Capital Partners. The investments are set to fast-track the growth of George Health Enterprises, the commercial arm of the world-leading George Institute for Global Health, and George Medicines, its late-stage drug development company. George Health Enterprises will receive almost £17 million from Federation Asset Man…

– Gilead Gains Forty Seven’s Investigational Immuno-Oncology Therapy in Multiple Clinical Studies for Diseases Including Myelodysplastic Syndrome, Acute Myeloid Leukemia and Diffuse Large B-Cell Lymphoma – – Transaction Supports Gilead’s Strategic Focus in Oncology and Gives Access to Potential New First-in-Class Program and Innovative Pipeline – FOSTER CITY, Calif. & MENLO PARK, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Forty Seven, Inc. (Nasdaq: FTSV) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Forty Seven for $95.50 per share in cash. The transaction, which values Forty Seven at approximately $4.9 billion, was unanimously approved by both the Gilead and Forty Seven Boards of Directors and…

CROMSOURCE announced today the achievement of a significant milestone in the digital management of clinical research projects for their clients. In February 2020 CROMSOURCE initiated the 1000th trial to be managed within the advanced TheClinical digital environment. TheClinical, developed by Techorizon, consists of customisable, integrated modules dedicated to the efficient digital management of every aspect of clinical research and development projects. ‘Digitalisation is a key foundation of our working philosophy, and has been a significant source of our investment for many years’, commented CROMSOURCE CEO, Dr. Oriana Zerbini. ‘Our adoption and development of digital technologies provides our clients with benefits in efficiency, quality and visibility on their projects.’ ‘Our clients typ…

Developing drugs to treat rare diseases is fraught with challenges; these range from trying to recruit from tiny patient populations to fill much-need clinical trials to the complex reimbursement landscape for these innovative, and often bespoke, therapies. GlobalData’s Pharmaceutical Technology writer Allie Nawrat looks at three case studies of companies on the verge of having treatments for largely ignored rare diseases approved. Restoring DNA repair functionality to cells: Rocket’s Fanconi gene therapy Nawrat Says: “Fanconi anaemia (FA) is a rare paediatric inherited disease caused by a mutation in the FANC genes. Patients with Fanconi experience bone marrow failure as they are unable to create new blood cells. “Rocket wants to change this situation with its lentiviral vector gene the…

The Office for Life Sciences announces Harwell as one of six new designated Zones in the UK - the only one in Oxfordshire/ Thames Valley Thursday 20th February, Harwell, Oxfordshire: Announced today by the Office for Life Sciences, Harwell Science and Innovation Campus has been designated as a Life Sciences Opportunity Zone, which is awarded for a 10-year period. Harwell, already a world-renowned science and technology campus, is now one of only seven locations in the UK [six announced today], and the only one in Oxfordshire / Thames Valley, to hold the title. With this status secured, Harwell’s Life Sciences capabilities will continue to grow as the announcement further underscores the role of the Campus as a national hub for health and Life Sciences research, and a launch platform for co…

19th February 2020: Cegedim UK announces the launch of a new Mobile App for Healthcare Professionals. The app showcases Cegedim’s powerful clinical decision support web-services which everyday enable over 5,000 pharmacies to dispense and over 4,000 GP’s to safely select and prescribe medicines for patients. The app brings together technology and data to demonstrate the novel capabilities of Cegedim’s solutions to support clinicians, solutions providers and healthcare providers to provide safe and effective care in a scalable and cost effective package. The new online application is aimed at GPs, pharmacists and other healthcare professionals and provides access to up to date, unbiased and reliable medical information, for optimum clinical decision-making.  The App references Cegedim’s drug…

The Wuhan coronavirus outbreak shows no signs of slowing down, and developments in the unfolding story are so rapid that it can be difficult keep track of them. GlobalData’s Pharmaceutical Technology team have produced a free-to-access dashboard to keep industry, media, and the public, up-to-date with the latest developments in the coronavirus outbreak and a range of tools to provide key information. The dashboard contains: Breaking news and regional reports Maps and trackers of confirmed cases, global spread, deaths and recoveries Timeline of events from the first cases to the latest news Social media tracking analysing trending keywords, hashtags, mentioned companies and countries An FAQ resource answering common questions Click on the link below to visit the web page. https://www.phar…

San Diego, CA and London, UK – February 11, 2020 –PHASTAR, a global CRO, announced today that the company has chosen San Diego as the site for its new U.S. west coast office, which will be led by Dr. LaRee Tracy, PhD, as Director of Biostatistics.  The San Diego office will serve as a strategic operational hub to support PHASTAR’s west coast customers and is a key component of the company’s current 5-year growth plan.   Dr. Tracy brings to PHASTAR more than 24 years’ experience in clinical research, industry regulation and clinical operations, including over 16 years working as an FDA CDER statistician. Her areas of expertise include biostatistics, experimental and observational study design, as well as significant experience with FDA processes and regulations. “We are excited to add San D…