Clinical research - Today Stories

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…

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…