Clinical research - Today Stories

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…

Further expands service offering to pharma and biotech customers Establishes Thermo Fisher as a global leader in the attractive and high growth clinical research services industry Adds highly complementary services for the company's fastest growing end market Offers both meaningful cost and revenue synergies which will further accelerate growth Expected to be immediately and significantly accretive to Adjusted Earnings Per Share (EPS)¹ after close Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher"), the world leader in serving science, and PPD, Inc. (Nasdaq: PPD) ("PPD"), a leading global provider of clinical research services to the pharma and biotech industry, today announced that their boards of directors have approved a definitive agreement under which Thermo Fisher will acqu…

Crossover allows participants to continue in trials and remain blinded Ensures that all trial participants receive active vaccine South Africa and UK crossover arms initiated; US/Mexico PREVENT-19 crossover planned Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the company's COVID-19 vaccine candidate. Crossover ensures the administration of active vaccine to all participants in the trials and has begun for Novavax' Phase 2b trial in South Africa and its pivotal Phase 3 trial in the United Kingdom. Under Novavax' updated clinical trial protocols[1], all participants in the UK and US Phase 3 trials will be offered the o…

Trial to enrol up to 30,000 volunteers worldwide Fast Track designation granted by US FDA Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study. Medicago received approval from Canadian and US regulatory authorities to proceed with enrolment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. “We are pleased to take the significant step of initiating the Phase 3 clinical trial at sites around the world,” said Takashi Nagao, CEO and President of Medicago. “This brings us one step closer to delivering an impo…

21st January 2021 – St. Andrews, Scotland – Pneumagen Ltd, focused on preventing and treating respiratory infections by targeting the human glycome, today announced a further GBP2.5 million investment from existing investors plus a new undisclosed global corporate investor, based in the US. The investment will be used to support the clinical development of Neumifil™ in 2021 as an intra-nasal formulation for the prevention and treatment of influenza, Respiratory Syncytial Virus (RSV) and COVID-19. This additional investment follows on from last year’s announcement of a GBP £4 million investment, and brings the total amount of financing raised to circa £9.5 million. Neumifil™ is a first-in-class Carbohydrate Binding Module (mCBMs), generated using the Company’s proprietary GlycoTarge™ platfo…

• Collaboration focuses on up to three types of lung and gastrointestinal (GI) cancers • Latest in a series of strategic acquisitions and partnerships that strengthens Boehringer Ingelheim’s position in the cancer vaccine and T-cell engager spaces • Agreement and partnership with Boehringer Ingelheim provides additional validation of Enara Bio’s EDAPT™ platform and Dark Antigen™ discovery work and supports ongoing cell therapy based therapeutic approach Ingelheim, Germany and Oxford and London, UK, January 12th, 2021 – Boehringer Ingelheim and Enara Bio, today announced that they have entered into a strategic collaboration and licensing agreement to research and develop novel targeted cancer immunotherapies, leveraging Enara Bio’s Dark Antigen™ discovery platform. This new collaboration…

COMIRNATY® (also known as BNT162b2) receives conditional marketing authorization from the European Commission; this milestone represents a global joint effort to advance the first authorized mRNA vaccine Pfizer and BioNTech are ready to immediately ship initial doses to the 27 EU member states Pfizer and BioNTech previously announced an agreement with the European Commission to supply 200 million vaccine doses to EU member states; the EU also has an option to purchase an additional 100 million doses in 2021 The vaccine has now been granted a conditional marketing authorization, emergency use authorization, or temporary authorization in more than 40 countries worldwide, including all 27 EU member states NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech…

AstraZeneca and Amgen today announced high-level results from the SOURCE Phase III trial which assessed the efficacy and safety of the potential new medicine tezepelumab compared to placebo in 150 severe asthma patients who required maintenance use of oral corticosteroids (OCS) on top of standard of care (SoC). The 48-week trial did not meet the primary endpoint of a statistically significant reduction in the daily OCS dose, without loss of asthma control, with tezepelumab compared to placebo. Tezepelumab’s effect on other efficacy parameters was similar to those observed in previous trials, including the registrational Phase III NAVIGATOR trial. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Based on the totality of evidence, including the compelling exacerbat…

World Antibiotic Awareness Week aims to increase awareness of global antibiotic resistance and to encourage best practices among the general public, health workers and policy makers to avoid the further emergence and spread of antibiotic resistance.A global action plan to tackle the growing problem of resistance to antibiotics and other antimicrobial medicines was endorsed at the Sixty-eighth World Health Assembly in May 2015. One of the key objectives of the plan is to improve awareness and understanding of antimicrobial resistance through effective communication, education and training.

(Reuters) - Pfizer Inc PFE.N on Monday said its experimental vaccine was more than 90% effective in preventing COVID-19 based on initial data from a large study, a major victory in the fight against a pandemic that has killed over 1 million people, roiled the world's economy and upended daily life. Pfizer and German partner BioNTech SE BNTX.O are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek U.S. emergency use authorization later this month. If authorized, the number of vaccine doses will initially be limited. Many questions also remain including how long the vaccine will provide protection. However the news provides hope that other vaccines in…

UK-based Contract Research Organisation (CRO) Gentronix – the largest independent genetic toxicology CRO in Europe - has appointed a new Operations Director to accelerate its strategic growth plans.  Laura Hinton, whose previous role was as Director of Scientific Operations at Cyprotex, will join the senior executive team working alongside fellow Operations Director Nick Billinton to facilitate a ‘scale at pace’ growth strategy for the business in line with burgeoning market demand as well as growth into new markets and service areas. As a leading predictive toxicology contract research organisation, Gentronix’s work helps develop safe products used by millions of people around the world including pharmaceuticals, agrochemicals, fragrances, foods and cosmetics. The business has a specialis…

Kancera AB (Nasdaq First North Premier Growth Market: KAN) announces that screening of covid-19 patients for the clinical phase II study of KAND567 starts today. The study, which is carried out in collaboration with Capio St. Göran's Hospital and Petter Brodin's research group at SciLifeLab, aims to study the effect of KAND567 on the immune system, lung function and rehabilitation. Results from the study will be analyzed and communicated on two occasions, the first after all patients have undergone sampling after day 7, and the second after day 90. Kancera develops drugs that counteract damage in acute and chronic inflammation. The Fractalkine blocker KAND567 is primarily developed to effectively counteract hyper-inflammation in various disease states and thereby protect vital organs, e.g.…

The Chief Executive of the UK’s pharmaceutical industry association has today warned MPs about the consequences of not agreeing a comprehensive post-Brexit trade deal or an urgent agreement on medicines while the trade talks continue. Richard Torbett told the Commons EU Future Relationship Committee that negotiators must consider the impact of causing unnecessary disruption and delays for UK and EU medicines whilst in the midst of a global pandemic. The Committee heard that companies were working in a constant state of emergency with supply chains under incredible pressure from COVID-19: "We need the bare minimum in order to safeguard risk to the supply chain [for medicines]. If we don’t get this there will be increased complexity, duplication and cost – the last thing we need during COVI…

It’s been 6 months since PharmiWeb, Europe’s largest pharma job board, launched our job board in Australia. Despite the backdrop of COVID-19, a massive thanks go out to all of our clients and all of the talented individuals who have engaged with our site, and come on board!We’re looking forward to the next 6 months as we continue to raise PharmiWeb’s profile across the continent, and help more and more Australian Life Sciences organisations recruit the best talent from PharmiWeb's ever-growing talent pool.If you would like more information regarding Pharmiweb and what our unique services can do for you, contact Sue or Laurel:Sue van Vuurensue.vanvuuren@pharmiweb.comTel: +61 (0) 468 625 626Laurel Steynlaurel.steyn@pharmiweb.comTel: +61 (0) 423 665 441Find Out More Here #pharmiweb #pharmajob…

After months of waiting, the official NHS COVID-19 contact tracing app for England and Wales is now available.   Protect your loved ones with the official NHS COVID-19 contact tracing app for England and Wales. It's the fastest way of knowing when you're at risk from coronavirus (COVID-19). The quicker you know, the quicker you can alert your loved ones, and your community.  The more of us that use it, the better we can control coronavirus. Protect your loved ones. Please download the app.

Responding to the news that the Covid-19 vaccine trial being run by Oxford University in conjunction with AstraZeneca has been halted for a second time, Kate Shaw, CEO of Innovative Trials, a clinical trials patient recruitment company, hoped it would not deter people from participating in clinical trials, either now or in the future. Shaw said: “I wish the clinical trial participant in question a swift recovery, but it’s important to note that a temporary halt on research is not uncommon and does not automatically mean a medicine is unsafe. Many treatments and vaccines can experience a pause during their development, even ones that are ultimately successful and brought to market.  “This news highlights the need for greater public awareness of what clinical research involves in order to av…