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WHO proclaimed the outbreak of the Ebola virus disease (EVD), in 2014 that killed hundreds of people in West Africa. The development of vaccines for SARS-CoV-2 becomes more difficult due to the viral mutation in its non-structural proteins (NSPs) especially NSP2 and NSP3, S protein, and RNA-dependent RNA polymerase (RdRp).
The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. About Molnupiravir.
They are currently working with Boehringer Ingelheim to further identify and develop these antibodies. They are expected to enter clinicaldevelopment later this year. This means that only minor changes are needed to effectively identify and neutralize the virus. They found a total of 28 neutralizing antibodies.
Louis is being advanced toward Phase I human clinical trials to treat COVID-19. Designed computationally and refined in the laboratory, the new protein therapies thwarted infection by interfering with the virus’ ability to enter cells. This work was originally reported in 2020 in the journal Science. 2 omicron subvariant.
While current polyclonal antibody (pAb) therapies are derived from plasma, GigaGen has developed single-cell discovery and development platforms to produce diverse and potent recombinant pAb therapies that are made in the laboratory.
The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021. “It About Molnupiravir.
Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 There was a 1.08
Laboratory professionals in all areas of science have experienced significant changes in recent years, and 2022 was no exception. Experts in the diagnostics and life sciences industry look back on 2022 and lend their insights on the major trends and technologies shaping laboratories in 2023.
28, 2020 /PRNewswire/ — Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today announces the formation of a new Scientific Advisory Board (SAB). OSLO, Norway , Oct. Fennel cover the key scientific focus areas of Targovax.
Dean A.
Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinicaldevelopment. The LY-CoV555 antibodies are infection fighting that can bind to the surface of viruses and prevent the virus infecting cells.
Hepatitis B virus (HBV) infection remains a significant public health challenge, particularly in low- and middle-income countries (LMIC) and in the Asia-Pacific region. Coordinated efforts are needed to combat this disease and improve the clinical status of persons with HBV infection.
Under her leadership, Pfizer advanced into clinicaldevelopment or approval bacterial vaccine programs directed at the prevention of diseases due to Streptococcus pneumoniae, Group B Streptococcus, Neisseria meningitidis, Staphylococcus aureus, and Clostridium difficile. Dr. Anderson joined Pfizer via Wyeth in 2007.
About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
The extensive Actemra/RoActemra RA IV clinicaldevelopment programme included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. We also continue to identify, develop and support potential therapies which can play a role in treating the disease.
Dr. John Teerlink – Professor of Medicine, University of California, San Francisco and Director of Heart Failure and the Echocardiographic Laboratory at the San Francisco Veterans Affairs Center. Wells is the author or co-author of over 400 published articles.
Cardiol Therapeutics Inc. (
Senior Vice President and Head of Global ClinicalDevelopment at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinicaldevelopment program.” “The investigational cocktail is now available to indicated high-risk U.S.
said, “Nearly 30 years ago my laboratory at Columbia University generated the first anti-CD40-ligand mAb (5c8), discovered and characterized human CD40-ligand and elucidated the molecular basis of T cell helper function 1. If claims are granted, a patent issuing from a national stage of this application could potentially provide U.S.
The program is being led by Sosei Heptares and progressed in collaboration with multiple companies including Syngene International, Domainex, Fidelta, o2h Discovery, Piramal, WuXi AppTec and the MRC Laboratory of Molecular Biology.
Today’s results show us the potential power of cell therapy for patients with lymphoma when used earlier, and instead of standard treatment options,” said Frank Neumann, MD, PhD, Kite’s Global Head of ClinicalDevelopment. The most common non-laboratory adverse reactions (incidence ?20%)
Senior Vice President and Head of Global ClinicalDevelopment at Regeneron. All patients entering the trial were hospitalized with laboratory-confirmed COVID-19 requiring low-flow oxygen, and all received other background standard-of-care as required.
LABORATORY ABNORMALITIES. Some patients treated with ZOKINVY developedlaboratory abnormalities. Eiger’s lead clinical programs target Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis. Eiger is developing two complementary treatments for HDV. times the human dose.
Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinicaldevelopment in the world.
Thus, our clinical study is both timely and potentially a life changer for the COVID-19 patients. The scientific concept, to activate nasal mucosal immunity by nasally administered Foralumab, is to fight against the virus in the respiratory tract and lungs,” stated Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.
vice president of immunology development at Lilly. “We are looking forward to sharing the totality of data from the overall clinicaldevelopment program for baricitinib as a potential first-in-disease treatment for alopecia areata.” herpes zoster), were reported in clinical studies with Olumiant.
regulators, and certain laboratories – had new roles that they needed to adapt into their updated quality management systems. Some of these systems included the registration and vigilance database, EUDAMED, expert panels, the clinical and performance evaluation consultation procedures, and the establishment of E.U. regulators.
vice president of immunology development at Lilly. “The results of this study underscore baricitinib’s potential in alopecia areata, and we look forward to continuing the clinicaldevelopment program for baricitinib in hopes of becoming the first FDA approved treatment option for adults with AA.”
“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. on October 22, including those at high risk of severe complications of COVID-19 disease.
Based on these promising findings, Transgene intends to continue the clinicaldevelopment of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. 27, 2020 06:30 UTC.
V590 — a SARS-CoV-2 vaccine candidate in development in collaboration with the International AIDS Vaccine Initiative (IAVI) that uses a recombinant vesicular stomatitis virus (rVSV) platform, the same platform used for Merck’s approved Ebola Zaire virus vaccine, will enter Phase 1 development shortly.
REGN5458 and odronextamab are currently under clinicaldevelopment, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.
Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. The most common Grade 3 or higher infection was pneumonia. Cytopenias.
“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.
In the third year of the COVID-19 pandemic, we also see the virus’s lingering effect on industry operations. Clinicallaboratory diagnostic services were most likely to be outsourced (80%), with data management , clinical trial management and biostatistical analyses (74%, 63% and 58%, respectively) close behind.
XELJANZ has been studied in more than 50 clinical trials worldwide and prescribed to over 208,000 adult patients (the majority of whom were RA patients) worldwide in the last eight years. Viral reactivation including herpes virus and hepatitis B reactivation have been reported. LABORATORY ABNORMALITIES. INDICATIONS.
Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent.
XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012. Viral reactivation including herpes virus and hepatitis B reactivation have been reported. MALIGNANCIES.
To effectively combat the COVID-19 pandemic, there remains a critical need for multiple therapeutic options to treat patients who have contracted the virus,” said Tamas Koncz, M.D., Viral reactivation including herpes virus and hepatitis B reactivation have been reported. LABORATORY ABNORMALITIES. MALIGNANCIES.
The final version newly clarifies that oncolytic viruses also fall outside the scope of the document and includes a new disclaimer that the guidance is not intended to address unique considerations of pediatric drug development.
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