Clinical research - Today Stories

David Spencer-Percival founded Spencer Ogden and Huntress - two globally successful recruitment firms Life Science People launches with a commitment to boost employment opportunities post Covid-19 London, 01 September 2020: David Spencer-Percival, serial entrepreneur and founder of two globally successful recruitment businesses, Huntress and Spencer Ogden, is launching his latest venture, Life Science People. With a personal investment of £2m and an initial team of 20, Spencer-Percival’s team have set their sights set on ambitious growth, with plans to have a London office of 100 by December, and nine international offices within five years. In launching Life Science People he continues his commitment to hiring and training graduates, something he has maintained throughout all of his ven…

A new therapy that could treat people with diabetes suffering from COVID-19 is to undergo an advanced clinical trial in the UK.  The first patient will be dosed this week. The Medicines and Healthcare products Agency (MHRA) has approved the trial following new preclinical research that suggests a glucose kinase activator (AZD1656) could help diabetes sufferers infected with coronavirus by dampening the overactive response of the immune system typically acute in those patients with raised blood glucose levels. The trial will involve hospitalised patients with mild to moderate COVID-19 symptoms and if successful the compound could ultimately be prescribed by a GP for people with diabetes presenting with early COVID symptoms. People living with diabetes face a significantly higher risk of dyi…

Oslo, Norway, 6 August 2020. Nordic Nanovector ASA (OSE: NANO) today announces that, following a planned interim analysis of the PARADIGME Phase 2b pivotal trial of Betalutin® in patients with relapsed/refractory follicular lymphoma (FL), the Independent Review Committee (IRC) has recommended Nordic Nanovector to focus on one dosage arm (15 MBq/kg Betalutin® after a pre-dose of 40 mg lilotomab; “40/15”) to completion. In this very difficult to treat patient population (bulky disease, patients refractory to standard therapies) the interim analysis confirmed activity. Betalutin®, as a single administration, was active (CR, PR and disease control rate) and had a well-tolerated safety and manageable safety profile in both arms. Based on a comprehensive assessment, the interim data set supporte…

Improvements also demonstrated in quality of life, lung function and nasal polyposis symptoms 05 August 2020  Results from the positive Phase IIIb ANDHI trial showed AstraZeneca’s Fasenra (benralizumab), when given on top of standard of care, demonstrated a statistically significant 49% reduction in the annual rate of asthma exacerbations at week 24 compared to placebo (0.94 vs. 1.86; p≤0.0001) in patients with baseline blood eosinophil counts greater than or equal to 150 cells per microlitre.1 These data were presented today at the American Thoracic Society 2020 Virtual International Conference.1 In key secondary endpoints, Fasenra demonstrated a statistically significant and clinically meaningful improvement in health-related quality of life at week 24 compared to placebo (p≤0.0001), wi…

Heidelberg (Germany), 3 August 2020: Pharma business development requires meeting other people but this has become very difficult in times of distancing, travel restrictions and quarantine. The traditional model of "partnering events" has suffered a blow and so have organisers. The workaround of merely replacing physical by video one-on-one meetings on the same conference days meets organisational and technical glitches.RauCon has developed an entirely novel, Corona-proof partnering concept which is now online and running. The new Marketplace for Pharma Business Opportunities provides an unprecedented degree of flexibility in pharma partnering by adding full four weeks of pre-arranged and secure, one-hour video meetings to the physical two-days euroPLX or asiaPLX events. Attendees can move…

BASINGSTOKE, August 3, 2020 – Eli Lilly and Company today announced the initiation of BLAZE-2, a Phase 3 trial studying LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the U.S. (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities). LY-CoV555, the lead antibody from Lilly’s collaboration with AbCellera, is a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19. The rapid spread of SARS-CoV-2 among residents of long-term care facilities combined with the higher mortality rate for the elderly creates the urgent need for therapies to prevent COVID-19 in this vulnerable population. “COVID-19 has had a devastating impact on nursing home residents. We’re worki…

Open Orphan plc "Open Orphan" or the "Company" Awarded Contract from Codagenix Inc. New York USA for COVID-19 Vaccine Trial Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials is pleased to announce a new contract with Codagenix Inc. (“Codagenix”) to conduct a first in human (Phase I) trial evaluating safety and immunogenicity of a single-dose, intranasal SARS-CoV-2 (COVID-19) vaccine candidate in 48 healthy young adult volunteers.  Highlights: First in human (Phase I) study of CodaVax-COVID, a codon deoptimized SARS-CoV-2 (COVID-19) single-dose, intranasal vaccine candidate Vaccine being trialled at hVIVO’s state-of-the-art Quarantine Facility in…

Saint-Herblain (France), July 20th, 2020 – Valneva SE, a specialty vaccine company focused on prevention against diseases with major unmet needs, today confirmed its participation in the UK government COVID-19 vaccine response program. Valneva has reached agreement in principle with the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine candidate, to be manufactured at its facilities in Livingston, Scotland. The UK government is expected to contribute to UK clinical studies costs and is negotiating funding to expand Valneva’s Scottish facility. As part of its broader COVID-19 response, Valneva plans to further invest in its manufacturing facility in Livingston, Scotland and also in Solna, Sweden. Thomas Lingelbach, CEO of Valneva, commented, “We are delighted to hav…

OXFORD, 20 JULY 2020: Vaccitech Ltd, a clinical-stage biopharmaceutical company developing immunotherapies to treat and prevent infectious diseases and cancer, today announces that Oxford University’s Jenner Institute and Oxford Vaccine Group have taken the next step towards the discovery of a safe, effective and accessible vaccine against coronavirus. The vaccine, ChAdOx1 nCoV-19, now known as AZN1222, was co-invented by Vaccitech and Oxford University’s Jenner Institute. The results of the Phase I/II trial published today in the scientific journal, The Lancet, indicate no early safety concerns and the induction of strong immune responses in both parts of the immune system. The vaccine provoked a T cell response within 14 days of vaccination (a cellular immune response, it cou…

DANBURY, Conn. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--IQVIA™ (NYSE:IQV) has announced its collaboration with AstraZeneca (LON: AZN) to accelerate development of a potential new vaccine for COVID-19. This joint initiative is part of the U.S. government’s recently announced Operation Warp Speed project. Operation Warp Speed is part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The specific IQVIA and AstraZeneca collaboration will drive faster delivery of clinical studies in the U.S. aimed at demonstrating efficacy of AstraZeneca’s potential COVID-19 vaccine, AZD1222. This initiative includes an expansive subject study, which is expected to begin enrolling participants this summer and wil…

New UK fund cornerstoned by £50 million investment from the British Business Bank, through its Enterprise Capital Funds (ECF) programme Epidarex Capital III UK LP will invest in new life science companies from emerging research hubs across the UK, including spinouts from highly regarded universities Edinburgh, UK, 22 June 2020 - Epidarex Capital (“Epidarex”), a transatlantic life science venture firm, announces that it has closed Epidarex Capital III UK LP (the “Fund”) at £102.1 million. The Fund will build new life science companies based on world-class research and innovation from emerging hubs across the UK, including spinouts from highly regarded universities. Typical initial investments will range from £2 million to £5 million. The new Fund has been cornerstoned by the British Busin…

--- Royal Society of Chemistry gathers publishers of more than 4,400 scholarly journals and tens of thousands of books in landmark commitment to reduce bias --- --- Publications range across disciplines including STEM and medicine to humanities and social sciences --- --- American Chemical Society, BMJ, Elsevier, the Royal Society, Oxford University Press and Cambridge University Press among those to sign up --- --- Nobel Prize-winning chemist Professor Frances Arnold endorses RSC leadership --- Publishers responsible for tens of thousands of peer-reviewed journals and books have signed an agreement to take a proactive stance against bias, as they commit to working together to better reflect the diversity of their communities and to remove barriers for under-represented groups. The joint…

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…