03:00 Sat 30
|Sanofi Stops Supplying Hydroxychloroquine to COVID-19 Patients in Clinical Trials |
The malaria drug is quickly falling out of favor with the medical community as a potential treatment for the disease.
12:54 Fri 5
|NIH stops clinical trials for two experimental antibody COVID-19 treatments |
The National Institutes of Health said Thursday that it stopped enrollment in two clinical trials evaluating experimental COVID-19 therapies after discovering they likely do not provide a benefit to hospitalized patients. The treatment candidates are GlaxoSmithKline and Vir Biotechnology Inc.'s monoclonal antibody therapy and the privately held Brii Biosciences Inc.'s monoclonal antibody cocktail. Vir told investorson Thursday that the NIH had notified the company about stopping the trial. There were no safety concerns for either therapy. Over the past year, GSK's stock is down 20.0% and shares of Vir tumbled 9.4%, while the broader S&P 500 has rallied 20.4%. Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
|hitconsultant net |
18:56 Fri 5
|BioIntelliSense Partners with Leukemia & Lymphoma Society for Continuous Monitoring in Clinical Trials |
What You Should Know: –BioIntelliSense announced it has entered into a strategic partnership with The Leukemia & Lymphoma Society (LLS) to incorporate the BioSticker platform in clinical trials of hematological cancer patients. – The LLS clinical trials will include use of the BioSticker medical device for the continuous collection of vital sign and physiological data ... Read More
13:21 Wed 3
|Adoption of Digital Technologies in Clinical Trials |
Francesca Properzi and Sudip Sinha talk about how the results of an inaugural Clinical Trial Digital Tracker Survey indicate that many trial sites are still reluctant to integrate digital technologies into their processes.COVID-19 is making virtual and decentralized approaches to clinical trials more of a necessity. The pandemic interrupted or halted 80% of trials unrelated [...]
|news-medical net |
17:42 Fri 5
|New approach using virtual clinical trials could revolutionize drug development |
New cutting-edge research undertaken at the University of Leicester could revolutionize the way new drugs are developed and the way patients are cared for, through a pioneering new approach using virtual clinical trials
15:40 Tue 2
|How clinical trial software can be used to optimize clinical trials |
Automated clinical trial software for efficiencies The post How clinical trial software can be used to optimize clinical trials appeared first on .
19:41 Thu 4
|India's Covaxin Covid-19 Vaccine, Already in Use, Shows Promise in Trials |
The Indian maker of Covaxin says interim results from clinical trials suggest it is safe and effective, potentially removing one hurdle to New Delhis ambitious inoculation campaign.
10:47 Thu 4
|India's Covaxin Covid-19 Vaccine, Already in Use, Shows Promise in Trials |
Interim results from clinical trials suggested that Covaxin could be safe and effective, potentially removing one hurdle to New Delhis ambitious campaign to inoculate a vast population.
|scimex org |
02:00 Fri 5
|Ivermectin does not help those with mild COVID recover faster |
Ivermectin, a controversial anti-parasitic drug that has been touted by some as a potential Covid-19 treatment, does not help people with mild covid-19 recover faster, according to a new clinical trial. The trial found that the duration of symptoms was not significantly different for patients who received a 5-day course of ivermectin compared with placebo. the authors say the findings do not support the use of ivermectin for the treatment of mild COVID-19, although larger trials may be needed to understand effects on other clinically relevant outcomes.
|scimex org |
14:00 Wed 3
|Identifying the cause and potential treatment for COVID-19-induced heart damage |
A growing body of research suggests up to two-thirds of patients who have recovered from severe COVID-19 experienced some heart inflammation and about a quarter of patients hospitalised with the disease sustained some form of cardiovascular injury. New research by QIMR Berghofer has found some of the ways COVID-19 damages the heart, and identified a class of drugs that could potentially protect or reverse this cardiac injury. Canadian company Resverlogix has used the findings as the basis for expanding its clinical trial of the drug, apabetalone, in COVID-19 patients.
16:31 Fri 5
|Recruitment and Enrollment Underway at Eight Sites for Innovation Pharmas Phase 2 Clinical Trial of Brilacidin for COVID-19 |
WAKEFIELD, Mass., March 05, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (the Company), a clinical stage biopharmaceutical company, today reports that eight sites are now participating in the Companys international Phase 2 clinical trial assessing Brilacidin as a novel therapeutic in hospitalized patients with COVID-19.
17:30 Fri 5
|International Womens Day: The gender gap in clinical trials |
For International Womens Day, Medidata’s global compliance and strategy lead Fiona Maini discusses the importance of increasing female The post International Women’s Day: The gender gap in clinical trials appeared first on .
|CytoDyns Phase 3 Trial of Leronlimab (Vyrologix) Demonstrates 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients; Webcast Monday |
On March 05, 2021, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, reported that the Phase 3 trial of leronlimab for the treatment of severe-to-critical patients with COVID-19 demonstrated continued safety, substantial improvement in survival rate, and faster hospital discharge in critically ill COVID-19 patients. The trials data has been reported to the U.S. Food and Drug Administration (FDA), the U.K.s Medicines & Healthcare product Regulatory Agency (MHRA) and Health Canada (HC), and the company is in discussions with each to determine the best path forward for approval of leronlimab for treatment of COVID-19 in critically ill populations. A manuscript of the trials data is being prepared and will be submitted for publication in one or more major medical journals. Highlights from the trials data for this critically ill population include the following: --Survival Benefit: There was a 24% reduction in all-cause mortality (primary endpoint of the study) in the leronlimab arm versus the placebo arm of the study. --Shortened Time to Recovery: The average length of hospital stay was reduced by 6 days for patients who received leronlimab with 'commonly used COVID-19 treatments, also referred to as Standard of Care or SoC, compared to placebo patients who received SoC only, with a statistically significant p-value of 0.005. --Discharged Alive: In addition, patients who received leronlimab demonstrated an improved probability of 'discharged alive' at Day 28 (28% versus 11%), a 166% better rate than in the placebo group. read more
22:47 Fri 5
|CytoDyns Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients Treated with Leronlimab |
VANCOUVER, Washington, March 05, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY) , (CytoDyn or the Company'), a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, reported today the Phase 3 trial of leronlimab for the treatment of severe-to-critical patients with COVID-19 demonstrated continued safety, substantial improvement in the survival rate, and faster hospital discharge in critically ill COVID-19 patients. The trials data has been reported to the U.S. Food and Drug Administration (FDA), the U.K.s Medicines & Healthcare product Regulatory Agency (MHRA) and Health Canada (HC), and the Company is in discussions with each to determine the best path forward for approval of leronlimab for treatment of COVID-19 in critically ill population. A manuscript of the trials data is being prepared and will be submitted for publication in one or more major medical journals.
18:39 Thu 4
|Pregnant Patients Should Weigh Risk of COVID Jab, States Association of American Physicians and Surgeons (AAPS) |
TUCSON, Ariz., March 04, 2021 (GLOBE NEWSWIRE) -- The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) have recommended that COVID-19 vaccines not be withheld from pregnant or lactating patients if they are at high risk of complications from COVID. These organizations oppose barriers including a required consultation with a clinical care team. They also recommend against requiring pregnancy or COVID tests.
09:33 Wed 3
|Chinese company Sinovac's COVID-19 vaccines have displayed 83.5% efficacy rate in final Phase-III clinical trials i https://t.co/ckGsWjE1pQ |
|WHO Recommends Against Hydroxychloroquine To Prevent Covid-19, Oklahoma Is Stuck With Piles Of It |
Oklahoma is apparently trying to negotiate a return of 1.2 million hydroxychloroquine pills that the state purchased last year for around $2 million.
14:19 Fri 5
|JAMA study: Ivermectin doesn't speed up recovery for patients with mild COVID-19 |
New research indicates that ivermectin, a type of treatment for parasitic worms, does not help patients with mild COVID-19 recover any faster. The peer-reviewed study, published Thursday in JAMA, examined the findings of a double-blind, randomized trial conducted in Cali, Colombia, in roughly 475 people with mild symptoms of COVID-19. Researchers concluded 'the findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes.' The drug first caught the attention of clinicians in the early days of the pandemic after an in-vitro preprint study said the drug can inhibit replication of SARS-CoV-2, the virus that causes COVID-19. However, the Food and Drug Administration and others [l:cautioned back in April|https://www.fda.gov/animal-veterinary/product-safety-information/fda-letter-stakeholders-do-not-use-ivermectin-intended-animals-treatment-covid-19-humans%7CNEW] that trials needed to be conducted before the drug should be prescribed to COVID-19 patients. Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
|news google au |
16:30 Wed 3
|Team unlocks secrets of COVID heart damage - Yass Tribune |
Team unlocks secrets of COVID heart damage Yass Tribune US halts trials of plasma transfusions for COVID patients Medical Xpress NIH halts trial of COVID-19 convalescent plasma in emergency department patients with mild symptoms National Institutes of Health U.S. trial of COVID-19 blood plasma halted after no benefit found Reuters NIH halts convalescent plasma trial in patients with moderate COVID-19 symptoms Becker's Hospital Review View Full coverage on Google News
|news-medical net |
|Survey identifies top factor for longevity in clinical research coordinator positions |
Strong, collaborative relationships with principal investigators are a key factor of longevity in clinical research coordinator positions -- an essential, but increasingly transient job in executing treatment-advancing clinical trials, Vanderbilt University Medical Center researchers found.
|bioengineer org |
22:40 Fri 5
|Survey identifies factors in reducing clinical research coordinator turnover |
Credit: Vanderbilt University Medical Center Strong, collaborative relationships with principal investigators are a key factor of longevity in clinical research coordinator positions — an essential, but increasingly transient job in executing treatment-advancing clinical trials, Vanderbilt University Medical Center researchers found. Danielle Buchanan, BS, clinical translational research coordinator III in the Department of Neurology, and Daniel […]
23:44 Fri 5
|Adaptive Biotechnologies Announces FDA Emergency Use Authorization for T-Detect COVID to Confirm Recent or Prior COVID-19 Infection |
First and only clinical T cell-based test for patients to detect the unique T-cell signature specific to SARS-CoV-2, the virus that causes COVID-19
|hitconsultant net |
13:00 Tue 2
|ObvioHealth, RedHill Biopharma Launches First in Kind Remote COVID-19 Therapy Trial |
What You Should Know: – RedHill Biopharma, a specialty biopharmaceutical company, and ObvioHealth, a global virtual research organization, have partnered on the largest remote clinical study for a new at-home COVID-19 treatment, Upamostat. – The trial is being performed completely remotely in patients homes using ObvioHealths clinical trial ecosystem including digital devices, a patient-centric smartphone ... Read More
11:00 Wed 3
|'No time to wait': ALS drug trials create hope among researchers, patients |
With ALS treatments, success is measured by extending patients' lives by months. Some hope new drugs now being tested could slow the disease.
01:05 Thu 4
|ECR 2021: A Hybrid AI Approach to Predicting COVID-19 Severity |
Combining machine learning and deep learning with clinical data and chest X-rays can point to either mild or severe disease.A hybrid artificial intelligence (AI) approach that combines both machine (ML) and deep learning (DL) can predict the severity of a patients case of COVID-19 by using both clinical data and chest X-rays, say researchers from [...]
14:24 Wed 3
|NIH halts study evaluating convalescent plasma in people with mild or moderate forms of COVID-19 |
The U.S. government stopped a clinical trial evaluating convalescent plasma as a treatment for people with mild to moderate forms of COVID-19, saying the experimental treatment likely has no benefit to these patients. An independent safety monitoring board said that using convalescent plasma will not harm patients but it likely has no benefit, according to a news release put out Tuesday by the National Institutes of Health. Convalescent plasma is blood plasma gathered from people who have recovered from COVID-19; that plasma, which carries COVID-19 antibodies, is then given to people who are currently sick to help them recover from the disease. In this particular trial, the plasma was given to patients with at least one comorbidity who came to emergency rooms with mild or moderate symptoms of COVID-19. The NIH said that more than 100,000 people in the U.S. have been treated with convalescent plasma during the pandemic. Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
18:00 Tue 2
|Why I trust the COVID vaccine [PODCAST] |
“Many friends have asked for my perspective on the COVID vaccine. Answering this requires both an explanation of clinical trials and an understanding of what normally slows down pharmaceutical development. Importantly, COVID vaccines are required to go through the same process as every other pharmaceutical. Vaccination is a personal choice, but I 100 percent recommend […] Find jobs atCareers by KevinMD.com . Search thousands of physician, PA, NP, and CRNA jobs now. Learn more .
16:07 Thu 4
|COVID-19 Pediatric Vaccines: Challenges and Solutions |
The majority of COVID-19 vaccine clinical trials are targeting adults more than children. However, this situation needs to be remedied and quickly. Although early reports show that COVID-19 symptoms tend to be milder in children, some develop severe manifestations of the disease. With an even larger gap in symptomology between adults and children, adult […] The post COVID-19 Pediatric Vaccines: Challenges and Solutions appeared first on PharmaVOICE .
13:29 Thu 4
|NIH tells Vir that experimental COVID-19 therapy may not benefit patients |
Shares of Vir Biotechnology Inc. tumbled 5.4% in premarket trading on Thursday, the day after the company said the experimental COVID-19 treatment that it's developing with GlaxoSmithKline may not benefit patients. U.S.-listed shares of GSK were up 0.6% in trading before the market opened on Thursday. The investigational monoclonal antibody therapy was being tested in hospitalized COVID-19 patients in a Phase 3 clinical trial conducted by the National Institutes of Health until an independent safety board recommended that the trial investigators close the study to enrollment at this time, Vir said. 'While we are disappointed with the recommendation ... we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients,' Vir CEO George Scangos said in a news release. (Remdesivir, which is also called Veklury, was developed by Gilead Sciences Inc. and is the only COVID-19 treatment to have a full Food and Drug Administration approval.) Vir's stock is down 6.9% over the past 12 months, while the broader S&P 500 has gained 27.2%. Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
20:03 Thu 4
|NIH to study three experimental COVID-19 treatments |
The National Institutes of Health said Thursday that it is putting three more investigational COVID-19 treatments into Phase 2/3 clinical trials. The experimental therapies are: an inhalable beta interferon developed by Synairgen's ; AstraZeneca's monoclonal antibody combination, which will be tested as an infusion and also as an injection; and Sagent Pharmaceuticals Inc.'s oral serine protease inhibitor. Sagent is privately held. The NIH said it is trying to identify and study therapies aimed at treating people who develop mild or moderate forms of COVID-19. So far during the pandemic, there are few therapies available that effectively treat patients with COVID-19. Only one, Gilead Sciences Inc.'s Veklury, has received full approval from the Food and Drug Administration, though several other companies, including Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. have received emergency authorization for their antibody treatments. Over the past year, Synairgen's stock has soared 763.1%, while U.S.-listed shares of AstraZeneca are up 0.4%. The broader S&P 500 is up 27.2%. Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
|npr org |
14:48 Thu 4
|Data Show India's Homegrown COVID-19 Vaccine Works 2 Months After It Was Approved |
India's homegrown COVID-19 vaccine has been controversial because the Indian government approved its use before clinical trials showed it works. Now data is finally out.