Clinical Trials & Research

PRINCETON, N.J., April 7, 2021 /PRNewswire/ – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has conditionally accepted HyBryte™ as the proposed brand name for SGX301 (synthetic hypericin),
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April 7, 2021 - The New England Journal of Medicine (NEJM) today published the final results of Part A of the pivotal Phase 3 CARDINAL open label, single-arm study evaluating the safety and efficacy of sutimlimab for 26 weeks in people with primary cold agglutinin disease (CAD). Sutimlimab, a first-in-class investigational C1s inhibitor, met the primary and secondary
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TARRYTOWN, N.Y., April 9, 2021 /PRNewswire/ – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that newly updated National Institutes of Health (NIH) COVID-19 Treatment Guidelines strongly recommend that REGEN-COV™ (casirivimab with imdevimab) be used in non-hospitalized COVID-19 patients (“outpatients”) at high risk of clinical progression. The Category ‘AIIa’ is a ‘strong’ rating based on results of randomized trials. The recommendation from the NIH COVID-19 Treatments
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TARRYTOWN, N.Y., April 12, 2021 /PRNewswire/ –  REGEN-COV rapidly protected household contacts from exposure to SARS-CoV-2 at home, with 72% protection against symptomatic infections in the first week, and 93% in subsequent weeks Among individuals who developed symptomatic infections, REGEN-COV recipients cleared the virus faster and had much shorter symptom duration Regeneron will share data with U.S. FDA and
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SERENE is a Phase 3 single-arm, open-label study evaluating the contraceptive efficacy of investigational relugolix combination tablet in sexually active, healthy women ages 18-35 years Contraceptive potential of relugolix combination tablet supported by prior Phase 1 study that demonstrated 100% ovulation inhibition Data would support a potential indication of pregnancy prevention for women treated with
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TARRYTOWN, N.Y., April 12, 2021 /PRNewswire/ — Second Phase 3 trial undertaken in collaboration with NIAID to announce results today, both using subcutaneous administration of REGEN-COV in asymptomatic individuals without prior COVID-19 infection Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data from a Phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV™ (casirivimab with
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CAMBRIDGE, Mass., April 12, 2021 – Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today reported topline results from the Phase 2 KINETIC Study evaluating SAGE-324 in the treatment of people with essential tremor (ET). The study (n=67 full analysis set) achieved its primary endpoint of a statistically significant reduction from baseline compared to
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April 13, 2021 — A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low blood oxygen due to infection with SARS-CoV-2, the virus that causes COVID-19, has begun. The Phase 2 trial, called the COVID-19 anti-CD14 Treatment Trial (CaTT), is sponsored
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Reviewed by Emily Henderson, B.Sc.Oct 1 2020 A new study led by researchers from Brigham and Women’s Hospital and the University of Minnesota, Minneapolis sheds light on why female primary care physicians receive lower wages than their male counterparts. The study found that female PCPs generated 11 percent less revenue due to conducting 11 percent
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Print this page SEATTLE, Sept. 29, 2020 /PRNewswire/ – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that following a recent Pre-NDA meeting with the U.S. Food and Drug Administration (“FDA” or “the Agency”), the Company has reached an agreement to submit an NDA for the potential accelerated approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet count
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Print this page September 25, 2020 — Interim analysis from the ongoing Phase 1/2a clinical trial of the Janssen COVID-19 vaccine candidate (JNJ-78436735) was posted today on the pre-print server medRxiv. The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older
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Reviewed by Emily Henderson, B.Sc.Sep 26 2020 Criticisms of COVID-19 models by Democratic elites in May 2020 appeared to undermine public support for the models’ use – and trust in science more broadly – according to a series of survey experiments conducted with the participation of more than 6,000 Americans. However, whether Republican elites criticized
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Print this page NEW BRUNSWICK, N.J., September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a
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Reviewed by Emily Henderson, B.Sc.Sep 25 2020 Clostridioides difficile, or C. diff, is the leading cause of health care-associated infection in the U.S. Only two antibiotics, vancomycin and fidaxomicin, are FDA approved for the treatment of C. diff, but even these therapies suffer from high treatment failure and recurrence. Now, Purdue University innovators have advanced
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Print this page TOKYO — September 23, 2020 FUJIFILM Toyama Chemical Co., Ltd. (President: Junji Okada; hereinafter “FUJIFILM Toyama Chemical”) has announced today that primary endpoint has been met in phase III clinical trial of “Avigan Tablet” (generic name: favipiravir, “Avigan”) conducted in Japan for patients with novel coronavirus infections (hereinafter “COVID-19”). The efficacy primary
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Sep 23 2020 OXGENE™, a biotechnology company designing and developing scalable gene therapy technologies, has today announced the launch of its scalable, plasmid-free manufacturing system for AAV. OXGENE’s new TESSA™ technology addresses industry-wide challenges associated with robust and reproducible AAV manufacture at scale. These include high cost of goods, and low packaging efficiency. TESSA aims
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Print this page Tokyo, Basking Ridge, N.J. and Munich – (September 14, 2020) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that the first patient has been dosed in a phase 2 study evaluating patritumab deruxtecan (U3-1402), a HER3 directed DXd antibody drug conjugate (ADC), in patients with advanced or metastatic colorectal cancer who
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Print this page INDIANAPOLIS, Sept. 14, 2020 /PRNewswire/ – Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). ACTT-2 included more than 1,000 patients and began
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Print this page INDIANAPOLIS, Sept. 16, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment
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After screening more than 3,500 FDA-approved drugs and small molecules, researchers at the Chinese Academy of Sciences found that ceftazidime, an antibiotic approved for use in treating pneumonia, binds to the receptors that the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) binds to in human cells. This drug could potentially be used to prevent virus
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Print this page HAMILTON, Bermuda, Sept. 15, 2020 (GLOBE NEWSWIRE) – Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to mavrilimumab for the treatment of giant cell arteritis (GCA). Mavrilimumab
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