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FDA releases draft guidance on measuring patient-reported outcomes in cancer clinical trials

The following quote is attributed to Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research.

9 Jun 2021

Mix and match COVID-19 vaccines safe and effective: German study

A new preprint study posted to the medRxiv* server shows an AstraZeneca’s ChAdOx1-nCov-19 and Pfizer/BioNTech BNT162b2 COVID-19 vaccine combination is immunologically superior to two AstraZeneca ChAdOx1-nCov-19 doses.

9 Jun 2021

New chip mimicking bovine endometrium could play key role in cattle’s pregnancy success

To investigate factors that can jeopardize pregnancy success in cattle, researchers at the University of São Paulo (USP) in Brazil used a kind of chip to mimic the environment of the endometrium, the tissue that lines the inside of the uterus.

8 Jun 2021

Novel COVID-19 vaccine is safe, generates immune response in healthy adults

The COVID-19 pandemic continues to disrupt and end lives around the world, and public health officials worldwide have recognized vaccines as the critical tools required for controlling the COVID-19 death toll and achieving a return to normal life.

8 Jun 2021

New drug shows promise against lung cancer caused by genetic mutation

The new drug sotorasib reduces tumor size and shows promise in improving survival among patients with lung tumors caused by a specific DNA mutation, according to results of a global phase 2 clinical trial.

8 Jun 2021

Study reports safety, efficacy of targeted treatment for IgA nephropathy

IgA nephropathy (IgAN) is a chronic kidney disease occurring in young adults and is one of the most common reasons for kidney transplantation in this age group.

7 Jun 2021

Oral antidiabetic medication provides kidney protection in focal segmental glomerulosclerosis

Focal segmental glomerulosclerosis (FSGS) is a rare form of kidney inflammation (glomerulonephritis) in which the glomeruli become increasingly scarred (sclerotic), leading to progressive loss of kidney function.

7 Jun 2021

Redhill Biopharma announces completion of enrollment for oral opaganib phase 2/3 COVID-19 study

RedHill Biopharma Ltd., a specialty biopharmaceutical company, today announced that it has completed enrollment and randomized the last patient in the global Phase 2/3 study with opaganib (Yeliva, ABC294640) in patients hospitalized with severe COVID-19 pneumonia (NCT04467840).

7 Jun 2021

New treatment may improve outcomes for patients with BRCA mutation-associated early breast cancer

Results were released this week on a new treatment with the potential to improve the outcomes for patients with hereditary BRCA mutations and high-risk, early-stage breast cancer.

5 Jun 2021

Weight loss drug Wegovy approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Wegovy (semaglutide) injection (2.4 mg once weekly) as a chronic weight management treatment in obese or overweight adults with a weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), when used along with calorie restriction and physical activity. Wegovy, is a more potent version of Novo Nordisk's diabetes drug semaglutide.

4 Jun 2021

Clinical trial evaluating mixed COVID-19 vaccine schedules begins at NIH

Vaccination efforts against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus behind the coronavirus disease (COVID-19) pandemic, are well underway in many countries. Over 2 billion vaccines have been administered to date, and campaigns continue to encourage more people to get vaccinated.

4 Jun 2021

Study: Nasal therapy is more effective than commonly used IgG antibodies at neutralizing COVID-19 virus

A nasal therapy, built upon on the application of a new engineered IgM antibody therapy for COVID-19, was more effective than commonly used IgG antibodies at neutralizing the COVID-19 virus in animal models, according to research recently published by The University of Texas Health Science Center at Houston (UTHealth), The University of Texas Medical Branch at Galveston (UTMB Health), the University of Houston, and IGM Biosciences, Inc.

4 Jun 2021

Centivax and US Naval Medical Research Center to begin Phase I clinical trial of antibody therapeutics

Centivax Inc. announced today that it has entered into a strategic partnership with the U.S. Naval Medical Research Center (NMRC) for Phase I clinical development of Centi-B9, Centivax's SARS-CoV-2 broad-spectrum injectable antibody therapeutic and prophylactic.

3 Jun 2021

NIH launches first-in-human, Phase 1 trial assessing investigational nanoparticle influenza vaccine

A first-in-human, Phase 1 trial assessing the safety and immunogenicity of an investigational nanoparticle influenza vaccine designed to provide long-lasting protection against multiple flu virus strains has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland.

1 Jun 2021

NIH starts Phase 1/2 clinical trial evaluating mixed COVID-19 vaccine schedules

The National Institutes of Health has started a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens.

1 Jun 2021

Using Sotrovimab to treat COVID-19 early

A new study published on the medRxiv* preprint server hypothesized that a monoclonal antibody that has the capability to neutralize all sarbecoviruses could also be used to target a highly conserved epitope. This conserved sequence has a high probability of remaining unchanged in SARS-CoV-2 variants.

31 May 2021

New drug effectively prevents severe COVID-19 in mice infected with SARS-CoV-2

The drug diABZI which activates the body's innate immune response -- was highly effective in preventing severe COVID-19 in mice that were infected with SARS-CoV-2, according to scientists in the Perelman School of Medicine at the University of Pennsylvania

29 May 2021

REAER is a promising therapy for improving the lives of people with multiple sclerosis

A team of multiple sclerosis (MS) experts at Kessler Foundation led the first pilot randomized controlled trial of robotic-exoskeleton assisted exercise rehabilitation (REAER) effects on mobility, cognition, and brain connectivity in people with substantial MS-related disability.

29 May 2021

New LNP-based mRNA vaccine candidate protects against lethal SARS-CoV-2 in preclinical trials

A new study, published in Nano Letters, describes an effective new COVID-19 vaccine candidate based on a messenger ribonucleic acid (mRNA) platform.

28 May 2021

COLCORONA study shows that colchicine can reduce complications in certain COVID-19 patients

The Montreal Heart Institute announces that the COLCORONA study results are published today in The Lancet Respiratory Medicine.

28 May 2021

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Drug Trial News

FDA releases draft guidance on measuring patient-reported outcomes in cancer clinical trials

Mix and match COVID-19 vaccines safe and effective: German study

New chip mimicking bovine endometrium could play key role in cattle’s pregnancy success

Novel COVID-19 vaccine is safe, generates immune response in healthy adults

New drug shows promise against lung cancer caused by genetic mutation

Study reports safety, efficacy of targeted treatment for IgA nephropathy

Oral antidiabetic medication provides kidney protection in focal segmental glomerulosclerosis

Redhill Biopharma announces completion of enrollment for oral opaganib phase 2/3 COVID-19 study

New treatment may improve outcomes for patients with BRCA mutation-associated early breast cancer

Weight loss drug Wegovy approved by FDA

Clinical trial evaluating mixed COVID-19 vaccine schedules begins at NIH

Study: Nasal therapy is more effective than commonly used IgG antibodies at neutralizing COVID-19 virus

Centivax and US Naval Medical Research Center to begin Phase I clinical trial of antibody therapeutics

NIH launches first-in-human, Phase 1 trial assessing investigational nanoparticle influenza vaccine

NIH starts Phase 1/2 clinical trial evaluating mixed COVID-19 vaccine schedules

Using Sotrovimab to treat COVID-19 early

New drug effectively prevents severe COVID-19 in mice infected with SARS-CoV-2

REAER is a promising therapy for improving the lives of people with multiple sclerosis

New LNP-based mRNA vaccine candidate protects against lethal SARS-CoV-2 in preclinical trials

COLCORONA study shows that colchicine can reduce complications in certain COVID-19 patients

How microRNA is transforming science: From discovery to diagnostics

Advancing benzodiazepine detection

The Surgeon-Scientist Pioneering Regenerative Engineering

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