Clinical Trials & Research

Mid-term results of the first clinical trial designed specifically to evaluate the safety and effectiveness of two cell therapies that are showing early promise in treating angiitis-induced critical limb ischemia were released today in STEM CELLS Translational Medicine. The study, by researchers at Zhongshan Hospital/Fudan University in Shanghai, compared how transplantation of peripheral blood mononuclear

Wednesday, December 23, 2020 U.S. government orders 100 million additional doses of the Pfizer-BioNTech COVID-19 Vaccine bringing total doses for U.S. to 200 million All 200 million doses expected to be delivered by July 31, 2021, allowing for 100 million people in the U.S. to be vaccinated NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

In 1986, cellular biochemist Kazumitsu Ueda, currently at Kyoto University’s Institute for Integrated Cell-Material Sciences (iCeMS), discovered that a protein called ABCB1 could transport multiple chemotherapeutics out of some cancer cells, making them resistant to treatment. How it did this has remained a mystery for the past 35 years. Now, his team has published a

BOSTON, Dec. 28, 2020 (GLOBE NEWSWIRE) – Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today announced results of the primary data cut from its Phase 3 clinical trial evaluating the safety and efficacy of eprenetapopt with azacitidine (AZA) versus AZA alone in TP53 mutant myelodysplastic

Scientists from the UCLA Jonsson Comprehensive Cancer Center have developed a simple, high-throughput method for transferring isolated mitochondria and their associated mitochondrial DNA into mammalian cells. This approach enables researchers to tailor a key genetic component of cells, to study and potentially treat debilitating diseases such as cancer, diabetes and metabolic disorders. A study, published

30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorisation for emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for the

The Grain Chain, a farm to fork coalition of stakeholders in the grain industry sector and chaired by the American Bakers Association (ABA), celebrates the recommendation published today in the 2020-2025 Dietary Guidelines for Americans (DGAs) to “consume half of your grains from whole grain sources” and the remainder from enriched grains. A foundational piece

PLYMOUTH MEETING, Pa., Dec. 24, 2020 /PRNewswire/ — INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced the publication of peer-reviewed Phase 1 clinical data from the first cohort of 40 participants for its COVID-19 DNA vaccine candidate,

The Phase 3 trial of another investigational coronavirus disease 2019 (COVID-19) vaccine has begun enrolling adult volunteers. The randomized, placebo-controlled trial will enroll approximately 30,000 people at approximately 115 sites in the United States and Mexico. It will evaluate the safety and efficacy of NVX-CoV2373, a vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland.

KENILWORTH, N.J.–(BUSINESS WIRE) December 23, 2020 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced it has entered into an agreement with the United States Government to support the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use

Tohoku University scientists have, for the first time, provided experimental evidence that cell stickiness helps them stay sorted within correct compartments during development. How tightly cells clump together, known as cell adhesion, appears to be enabled by a protein better known for its role in the immune system. The findings were detailed in the journal

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Dec. 17, 2020– Moderna, Inc., (Nasdaq:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for the Company’s COVID-19

In the ongoing coronavirus disease 2019 (COVID-19) pandemic, much research has focused on the role of neutralizing antibodies in countering infection by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Most of these studies have been based on genome sequencing, showing matches between the Hypervariable Region (HVR) and the antigen’s receptor-binding domain (RBD). The results have

London UK and San Francisco US 17 December 2020 — Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the first patient has been dosed in a new sub-trial of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is

Substances present in cooked meats are associated with increased wheezing in children, Mount Sinai researchers report. Their study, published in Thorax, highlights pro-inflammatory compounds called advanced glycation end-products (AGEs) as an example of early dietary risk factors that may have broad clinical and public health implications for the prevention of inflammatory airway disease. Asthma prevalence

18 December 2020 — The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anemia of chronic kidney disease (CKD). AstraZeneca and FibroGen, Inc. (FibroGen) are committed

The growth of prenatal screening in Europe has reduced the number of babies being born per year with Down syndrome (DS) by an average of 54%, according to a new study published in the European Journal of Human Genetics by researchers from Massachusetts General Hospital (MGH) and international Down syndrome organizations. In research published in

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Dec. 18, 2020– Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration’s (FDA) has authorized the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older. The Moderna COVID-19 Vaccine is now authorized for distribution and

Researchers have developed a detailed model of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission in New York and Seattle, USA. They found the risk of transmission is a combination of the place and the behavior of people who visit it. Several strategies have been put in place to curb the transmission of COVID-19, the

NEW YORK and MAINZ, GERMANY, December 14, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany. The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into

A new study offers strong evidence that kids who use e-cigarettes are more likely to take up smoking or smokeless tobacco, researchers say. Teen boys who vaped were almost three times as likely to start smoking as other teen boys with similar risk profiles and more than two times as likely to try smokeless tobacco,

Using the Hazard Analysis of Critical Control Points (HACCP) framework, researchers assessed the risk and mitigation strategies for universities with students returning to campus. The methodology allowed a rapid response to curb disease transmission with continuing education. The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has disrupted

Friday, December 11, 2020 U.S. FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. immediately Pfizer and BioNTech previously announced an agreement with the U.S. Government to supply doses in 2020 & 2021 In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other

A muscle fiber consists of just one cell, but many nuclei. A team at the MDC led by Professor Carmen Birchmeier has now shown just how varied these nuclei are. The study, which has been published in Nature Communications, can help us better understand muscle diseases such as Duchenne muscular dystrophy. Usually, each cell has

Once the COVID-19 pandemic is over, a lot of things will go back to normal. We’ll stop wearing masks. We’ll crowd into restaurants. We’ll walk whatever direction we want to down grocery store aisles. But some changes that the pandemic spurred might be here to stay. Among them: the expansion of telepsychiatry. This will be

Thursday, December 10, 2020 -  Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose Vaccine efficacy observed in the overall study

Over 69.41 million people around the world have been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and, of these, over 1.49 million people have lost their lives. The spread of the virus from person to person is rapid and has brought the economies of major nations to their knees due to public

8 December 2020 — Results of an interim analysis of the Phase III programme conducted by Oxford University with AZD1222, peer-reviewed and published in The Lancet today, demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation. The interim analysis for efficacy was based on 11,636