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FDA issues noncompliance notice for failing to submit clinical trial summary results to ClinicalTrials.gov

Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise.

28 Apr 2021

Clinical trial to test existing antibiotic for treating serious S. aureus infections begins

A clinical trial to test the antibiotic dalbavancin for safety and efficacy in treating complicated Staphylococcus aureus (S. aureus) bacteremia has begun.

27 Apr 2021

ANTICOV clinical trial to test new treatment for people with mild-to-moderate COVID-19 in Africa

The ANTICOV clinical trial, conducted in 13 African countries, has started the recruitment of participants to test a new drug combination, nitazoxanide + ciclesonide, to treat people with mild-to-moderate COVID-19 before their cases become severe.

27 Apr 2021

Single dose of J&J's Ad26.COV2.S vaccine effective against SARS-CoV-2 including in South Africa variant

One of these vaccines, the Ad26.COV2.S vaccine by Johnson & Johnson and Janssen, is a recombinant, replication-incompetent human adenovirus type 26 vector that encodes full-length SARS-CoV-2 spike protein in a prefusion-stabilized conformation.

26 Apr 2021

Real-world study in India finds COVISHIELD vaccine safe and effective

New research led by Naresh Trehan of Medanta-The Medicity in India found the COVISHIELD (ChAdOx1 nCoV-19 Corona Virus Vaccine) vaccine produced an immune response from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) two weeks after vaccination with limited side effects.

26 Apr 2021

Recombinant protein vaccine fails expectations for SARS-CoV-2 neutralization

New interim results of a phase 1-2 clinical trial published in The Lancet Infectious Diseases tested the safety and effectiveness of an adjuvanted recombinant protein vaccine against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) called CoV2 preS dTM.

26 Apr 2021

Potential new COVID vaccine from Australia

Phase 1 trial results published in The Lancet Infectious Diseases found a new subunit vaccine —an MF59-adjuvanted subunit vaccine using recombinant spike glycoprotein stabilized in a prefusion conformation by a novel molecular clamp — targeting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was safe and effective in producing an antigen-specific response in healthy adults.

26 Apr 2021

Two repurposed drugs and a blue dye show potential as SARS-CoV-2 entry inhibitors

A new multidisciplinary study from Australia, published in the open-access journal mBio, shows that three compounds used to treat cystic fibrosis, dry eye, and a specific medical dye may lead to future strategies for the treatment of coronavirus disease (COVID-19).

25 Apr 2021

DNA vaccine candidate induces potent immunity, offers protective efficacy in non-human primate models

A synthetic DNA vaccine candidate for Middle East respiratory syndrome coronavirus (MERS-CoV) developed at The Wistar Institute induced potent immune responses and afforded protective efficacy in non-human primate (NHP) models when given intradermally in abbreviated, low-dose immunization regimen.

23 Apr 2021

Celastrol shows potential anti-SARS-CoV-2 activity

A new study published on the bioRxiv* preprint server focuses on the in-silico predictions to repurpose existing drug compounds, that may have the ability to reverse the SARS-CoV-2 gene expression induced in host cells.

23 Apr 2021

Clinical trial examines metabolic effects of natural compound NMN in people

A natural compound previously demonstrated to counteract aspects of aging and improve metabolic health in mice has clinically relevant effects in people, according to new research at Washington University School of Medicine in St. Louis.

22 Apr 2021

New Phase 3 trial of therapeutics begins enrolling severely ill hospitalized COVID-19 patients

A new Phase 3 trial to test the safety and efficacy of therapeutics for COVID-19 has begun enrolling patients hospitalized with life-threatening cases of COVID-19, including those with acute respiratory failure.

22 Apr 2021

NCCS starts clinical trial to examine the use of TCM in countering cancer-related symptoms

The National Cancer Centre Singapore has started a clinical trial to examine the use of Traditional Chinese Medicine in countering cancer-related symptoms or side effects of cancer treatment to improve cancer survivors' quality of life.

22 Apr 2021

NIH funds large Phase 3 clinical trial to test repurposed drugs for treating COVID-19 symptoms

Using an ACTIV master protocol, the trial will focus on potential interventions for mild-to-moderate illness.

20 Apr 2021

Genethon announces dosing of first patient at pediatric clinical trial platform for neuromuscular diseases

A first participant was dosed at I-Motion, the pediatric clinical trial platform for neuromuscular diseases located at Trousseau hospital in Paris, as part of the gene therapy trial in Duchenne muscular dystrophy (DMD) conducted by Genethon.

20 Apr 2021

Sinovac COVID-19 vaccine shows 50% effectiveness in a cohort of Brazilian healthcare workers

CoronaVac is a well-tolerated vaccine containing inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and it induced humoral responses in phase 1 and 2 studies. Analysis of a Brazilian phase 3 clinical trial that evaluated 12,607 participants showed that the vaccine had an efficacy of 50.39% 15 days after the 2nd dose.

19 Apr 2021

Gene therapy for common forms of congenital blindness shows promise to improve vision

A new gene therapy for one of the most common forms of congenital blindness was safe and improved patients' vision, according to initial data from a clinical trial led by researchers at the Scheie Eye Institute in the Perelman School of Medicine at the University of Pennsylvania.

19 Apr 2021

Single dose of Oxford–AstraZeneca COVID vaccine shown to be more immunogenic than natural infection

By investigating antibody and T cell responses to a single dose of the Oxford–AstraZeneca COVID-19 vaccine, researchers from Sri Lanka and the United Kingdom have found that more than 90% of vaccinated individuals produced an adequate amount of antibodies after receiving only one dose of the vaccine – irrespective of their age and gender.

16 Apr 2021

Trial results show leishmaniasis vaccine is safe and induces immune responses in patients

The results of the first clinical trial of a new vaccine for a neglected tropical disease have demonstrated that it is safe and induces immune responses in patients with the infection.

15 Apr 2021

Evidence of sustained immune responses weeks after Pfizer-BioNTech BNT162b2 vaccination

A new study published ahead of print in the Clinical Chemistry and Laboratory Medicine (CCLM) journal reports the production of a robust immune response against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using the Pfizer-BioNTech BNT162b2 vaccine. The increase in humoral immunity includes elevated Immunoglobulin G (IgG) and Immunoglobulin A (IgA) levels after the second mRNA dose.

14 Apr 2021

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Drug Trial News

FDA issues noncompliance notice for failing to submit clinical trial summary results to ClinicalTrials.gov

Clinical trial to test existing antibiotic for treating serious S. aureus infections begins

ANTICOV clinical trial to test new treatment for people with mild-to-moderate COVID-19 in Africa

Single dose of J&J's Ad26.COV2.S vaccine effective against SARS-CoV-2 including in South Africa variant

Real-world study in India finds COVISHIELD vaccine safe and effective

Recombinant protein vaccine fails expectations for SARS-CoV-2 neutralization

Potential new COVID vaccine from Australia

Two repurposed drugs and a blue dye show potential as SARS-CoV-2 entry inhibitors

DNA vaccine candidate induces potent immunity, offers protective efficacy in non-human primate models

Celastrol shows potential anti-SARS-CoV-2 activity

Clinical trial examines metabolic effects of natural compound NMN in people

New Phase 3 trial of therapeutics begins enrolling severely ill hospitalized COVID-19 patients

NCCS starts clinical trial to examine the use of TCM in countering cancer-related symptoms

NIH funds large Phase 3 clinical trial to test repurposed drugs for treating COVID-19 symptoms

Genethon announces dosing of first patient at pediatric clinical trial platform for neuromuscular diseases

Sinovac COVID-19 vaccine shows 50% effectiveness in a cohort of Brazilian healthcare workers

Gene therapy for common forms of congenital blindness shows promise to improve vision

Single dose of Oxford–AstraZeneca COVID vaccine shown to be more immunogenic than natural infection

Trial results show leishmaniasis vaccine is safe and induces immune responses in patients

Evidence of sustained immune responses weeks after Pfizer-BioNTech BNT162b2 vaccination

How microRNA is transforming science: From discovery to diagnostics

Advancing benzodiazepine detection

The Surgeon-Scientist Pioneering Regenerative Engineering

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