Clinical Trials & Research

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.
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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
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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
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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
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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
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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
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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
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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,
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Saint-Herblain (France), December 16, 2020 – Valneva SE, a specialty vaccine company focused on prevention against diseases with major unmet needs, today announced the initiation of a Phase 1/2 clinical study for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. VLA2001 leverages the manufacturing platform of Valneva’s licensed Japanese encephalitis vaccine, IXIARO® and is the first publicly
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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
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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
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Researchers in the United States have conducted an analysis showing the high prevalence of mental disorders across populations impacted by coronavirus pandemics. The team’s meta-analysis of research on COVID-19, severe acute respiratory syndrome coronavirus (SARS) and Middle East respiratory syndrome (MERS) found that one in five adults developed pandemic-related mental disorders. Psychiatric morbidity and post-traumatic
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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
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Scientists at Trinity College Dublin today announced a significant advance in our understanding of an early onset form of dementia that may also progress our understanding of conditions such as Alzheimer’s disease. Adult onset Leukoencephalopathy with axonal Spheroids and Pigmented glia (ALSP) is an ultra-rare condition characterized by mutations in a gene called Colony stimulating
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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
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When agrochemical and pharmaceutical companies develop new products, they must test extensively for potential toxicity before obtaining regulatory approval. This testing usually involves lengthy and expensive animal studies. A research team at University of Illinois has developed a gene biomarker identification technique that cuts the testing process down to a few days while maintaining a
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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
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With increasing numbers of people suffering from coronavirus disease 2019 (COVID-19), and most recovering, the levels of protective immunity need to be measured over time to help measure the duration of protective immunity. A new paper, which appeared on the preprint server medRxiv* in December 2020, describes the development and validation of a rapid test
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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Dec. 14, 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 Company concluded an agreement with the Ministry of Health of Singapore to supply mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support ongoing efforts to secure
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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
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An interesting new modeling study suggests an impressive impact of the COVID-19 vaccine on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) attack rate (the risk of getting COVID-19), hospitalizations, and infections, even with no protection against infection. The results would also be improved if the vaccine prevented infection as well. The COVID-19 pandemic refuses
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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
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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
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