Clinical Trials & Research

PLYMOUTH MEETING, Pa., March 1, 2021 /PRNewswire/ – INOVIO, (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer and HPV-associated diseases, today announced it met primary and secondary endpoints among all evaluable subjects for the REVEAL 1 trial. This trial is one of
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One of the hallmarks of chronic pain is inflammation, and scientists at the UNC School of Medicine have discovered that anti-inflammatory cells called MRC1+ macrophages are dysfunctional in an animal model of neuropathic pain. Returning these cells to their normal state could offer a route to treating debilitating pain caused by nerve damage or a
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KENILWORTH, N.J.–(BUSINESS WIRE) March 1, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the company is voluntarily withdrawing the U.S. indication for Keytruda (pembrolizumab) for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least
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Lymph nodes in the armpit area can become swollen after a COVID-19 vaccination, and this is a normal reaction that typically goes away with time. Radiologists at Massachusetts General Hospital (MGH) who recently published an approach to managing this situation in women who receive mammograms for breast cancer screening in the American Journal of Roentgenology
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1 March 2021 — AstraZeneca and FibroGen, Inc. (FibroGen) today announced that the US Food and Drug Administration (FDA) informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for roxadustat. Roxadustat is under regulatory review for the treatment of anemia of chronic
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NEW BRUNSWICK, N.J., February 27, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. This
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22 February 2021 — AstraZeneca today announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer. This decision was made in consultation with the Food and Drug Administration (FDA). In May 2017, Imfinzi was granted accelerated approval in the US based on promising
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NEW BRUNSWICK, N.J., February 19, 2021– Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate. The data package delivered today includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical
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Strokes are a leading cause of poor quality of life or even death in Japan and the world over. Since its characterization, several researchers have been working tooth and nail to identify drug-accessible and effective therapeutic targets for this debilitating condition. One such region of interest for drug targets is the blood-brain barrier (BBB). The
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TOKYO, Feb. 19, 2021 /PRNewswire/ – Astellas Pharma Inc. (TSE: 4503) (President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 pivotal SKYLIGHT 1™ and SKYLIGHT 2™ clinical trials for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) – i.e., hot flashes associated
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Disorders of the cells’ energy supply can cause a number of serious diseases, but also seem to be connected to aging. More research is needed on mitochondrial function to find future treatments. A new study involving researchers at Karolinska Institutet shows how an important molecule inside the mitochondria affects their function in mice and fruit
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February 12, 2021 – Enrollment has begun to test additional investigational drugs in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. ACTIV is a public-private partnership program to create a coordinated research strategy that prioritizes and speeds development of promising COVID-19 treatments and vaccines. The new agents entering the randomized, placebo-controlled study are part of ACTIV-2, an adaptive
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A child’s first influenza infection shapes their immunity to future airborne flu viruses-;including emerging pandemic strains. But not all flu strains spur the same initial immune defense, according to new findings published today by University of Pittsburgh School of Medicine virologists in the journal PLOS Pathogens. These results are relevant right now to the COVID-19
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Moscow, February 12, 2021 – The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces the approval of Russian Sputnik V vaccine against coronavirus in Montenegro and Saint Vincent and the Grenadines. In total, 26 countries have already authorized Sputnik V. Saint Vincent and the Grenadines is the first island nation of the Caribbean to
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Delivering the benefits of agricultural biotechnology to smallholder farmers requires that resources be directed toward staple food crops. To achieve effect at scale, beneficial traits must be integrated into multiple, elite farmer-preferred varieties with relevance across geographical regions. For the first time, an international team of scientists, led by Narayanan Narayanan, Ph.D., senior research scientist,
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15 February 2021 — AstraZeneca’s COVID-19 vaccine has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunisation to prevent COVID-19 in individuals 18 years of age and older, including those over 65. The authorisation of COVID-19 Vaccine AstraZeneca manufactured by AstraZeneca, and COVISHIELD manufactured by Serum Institute of India (SII), enables global access
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Diagnostic testing, contact tracing, and the isolation of infected individuals and their contacts form the foundation of managing the current coronavirus disease 2019 (COVID-19) pandemic. Moreover, the number of positive tests is a key measure of the severity of the outbreak at regional, national, and international levels. The true number of infections with the severe
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5 February 2021 — The KESTREL Phase III trial for AstraZeneca’s Imfinzi (durvalumab) did not meet the primary endpoint of improving overall survival (OS) versus the EXTREME treatment regimen (chemotherapy plus cetuximab), a standard of care, in the 1st-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumours
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Using publicly available coronavirus disease 2019 (COVID-19) data from Israel, a study suggests the BioNTech-Pfizer BNT162b2 vaccine is proving highly effective in the real world. Several vaccines have now been approved for COVID-19, and many countries have started intensive vaccination programs. In Israel, vaccination started on December 20, 2020. By the end of January, 33%
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PALO ALTO, Calif., Feb. 8, 2021 /PRNewswire/ – Eiger BioPharmaceuticals, Inc (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, today announced that final results from the Phase 2 ILIAD (Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19) study published in Lancet Respiratory Medicine. ILIAD, an investigator sponsored randomized trial of
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The 1918 influenza pandemic provides a cautionary tale for what the future may hold for COVID-19, says a Michigan State University researcher. After a decade studying a flu virus that killed approximately 15,000 Michigan residents, Siddharth Chandra, a professor in MSU’s James Madison College, saw his research come to life as he watched the spread
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INDIANAPOLIS, Feb. 9, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together, Eli Lilly and Company (NYSE: LLY) announced today. This therapy is authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to
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