Clinical Trials: Page


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    Merck matches Roche in search for next cancer immunotherapy

    The maker of Keytruda unveiled data for three experimental cancer drugs, including results for an anti-TIGIT therapy that compare favorably to those for a similar medicine being developed by Roche.

    By Ned Pagliarulo • Sept. 21, 2020
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    Ewa Krawczyk, National Cancer Institute

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    With Eli Lilly data, another drug emerges to stop breast cancers from returning

    The highly anticipated results could change how some patients with the most common form of breast cancer are treated — and drive up the costs of care. 

    By • Sept. 20, 2020
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    Radiopharmaceuticals

    A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

    By BioPharma Dive staff
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    Amgen
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    Amgen's KRAS drug can shrink tumors for months, but new data leave room for improvement

    Study results unveiled Sunday, if replicated later this year, could be strong enough to garner an approval for Amgen's sotorasib, the first KRAS-blocking drug to get this far.

    By Ned Pagliarulo • Sept. 20, 2020
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    Jacob Bell/BioPharma Dive
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    Seattle Genetics stays step ahead of rivals with bladder cancer data

    Data confirming the company's drug Padcev can extend the lives of bladder cancer patients should strengthen its position with regulators, although Immunomedics is close behind with a competing treatment.

    By • Sept. 18, 2020
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    Courtesy of Roche
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    In unexpected finding, Roche claims arthritis drug may have role in treating COVID-19

    Previous study findings from Roche and others had indicated the Swiss drugmaker's Actemra, and other drugs like it, weren't helping patients hospitalized with coronavirus disease. 

    By • Sept. 18, 2020
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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    What to watch as the first late-stage coronavirus vaccine trials near potential readouts

    Predictions of results by the end of October look ambitious, as the number of COVID-19 cases needed to generate definitive data could still take months.

    By • Updated Sept. 17, 2020
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    Moderna
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    Vaccine makers, in bid for transparency, disclose detailed plans of coronavirus vaccine trials

    Moderna was the first to share the so-called study protocol of its Phase 3 trial, spurring Pfizer and AstraZeneca to quickly do the same.

    By Ned Pagliarulo • Updated Sept. 19, 2020
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    Kendall Davis/BioPharma Dive
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    Arrowhead shares soar on liver disease data from four patients

    Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.

    By • Sept. 16, 2020
  • Colorized scanning electron micrograph of a cell heavily infected with SARS-CoV-2 virus particles, isolated from a patient sample
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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    Lilly offers first evidence that its antibody drug may help treat COVID-19

    The results, from a mid-stage study of Lilly's drug, suggest treatment helped lower virus levels, but the degree to which patients benefited remains unclear. 

    By • Sept. 16, 2020
  • A volunteer in a clinical trial is dosed with BNT162, an experimental coronavirus vaccine developed by Pfizer and BioNTech
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    Permission granted by BioNTech SE
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    Pfizer says coronavirus vaccine study still on track for October readout

    Unusually, the drugmaker also shared blinded safety results from its ongoing Phase 3 trial, showing participants' side effects were generally mild to moderate.

    By Ned Pagliarulo • Sept. 15, 2020
  • This transmission electron microscope image shows SARS-CoV-2, the virus that causes COVID-19, isolated from a patient in the U.S.
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565662436/in/album-72157713108522106/.
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    Lilly says its arthritis drug helps speed COVID-19 recovery

    The benefit of adding Lilly's Olumiant to Gilead's antiviral Veklury appeared modest, reducing time to recovery by one day in a study of hospitalized patients.

    By Ned Pagliarulo • Sept. 14, 2020
  • AstraZeneca, Oxford vaccine study allowed to restart in UK

    Six days after a worrisome illness in a U.K. study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume.

    By • Sept. 12, 2020
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    Lydia Polimeni, National Institutes of Health
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    NIH starts broad set of studies testing blood thinners against COVID-19

    The trials, which involve Bristol Myers and Pfizer's Eliquis as well as other anticoagulants, follow evidence of blood clotting in COVID-19 patients.

    By • Sept. 11, 2020
  • Sanofi's hemophilia drug comes into focus as delays hit a key competitor

    With BioMarin's gene therapy sidelined, attention is turning to other drugs, including one Sanofi acquired when it paid $11.6 billion for Bioverativ. 

    By • Sept. 10, 2020
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    Intra-Cellular roars back on success in bipolar depression

    Widening the number of eligible patients could make Intra-Cellular's schizophrenia pill a blockbuster, analysts forecast.

    By • Sept. 9, 2020
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    Jacob Bell/BioPharma Dive
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    Merck takes aim at Pfizer with pneumonia vaccine data

    Results from two Phase 3 studies put Merck in position to ask for FDA approval of its shot later this year. Pfizer may not be far behind with a rival product. 

    By • Sept. 9, 2020
  • Studies of AstraZeneca coronavirus vaccine put on hold for safety review

    A participant in a clinical trial of the experimental shot suffered an unexplained illness, triggering an investigation and a global pause in vaccinations.

    By Ned Pagliarulo • Updated Sept. 9, 2020
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    Jacob Bell/BioPharma Dive
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    Merck details cough drug data, raising questions about its potential

    Merck's drug could be the first-ever treatment for chronic cough, a condition that afflicts millions. But side effects and modest efficacy may limit its use. 

    By • Sept. 8, 2020
  • Colorized scanning electron micrograph of a cell heavily infected with SARS-CoV-2 virus particles, isolated from a patient sample
    Image attribution tooltip
    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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    Researchers publish first data on coronavirus vaccine approved by Russia

    While the shot appeared less potent than those being advanced by U.S. and U.K. companies, the Russian vaccine could be used broadly because it doesn't need to be kept frozen.

    By • Sept. 4, 2020
  • Akebia stumbles and clouds the prospects of anemia pills

    The biotech's drug was found to be less safe than an injectable anemia medicine in a Phase 3 trial, dimming its potential approval chances.

    By • Sept. 3, 2020
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    GlaxoSmithKline
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    Sanofi, GSK, racing to catch up, begin first human study of coronavirus vaccine

    The two vaccine developers are betting their proven technology will lead to a more potent shot than others, making up for their slower pace of testing. 

    By • Sept. 3, 2020
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    After a rare win, a biotech details long-awaited results for its ALS drug

    Newly published data describe what one study investigator deems a milestone in the fight against ALS, a deadly and progressive neurological disorder.

    By • Sept. 2, 2020
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    Lydia Polimeni, National Institutes of Health
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    NIH panel says data doesn't support plasma use for COVID-19

    The expert advisers' determination appears to conflict with a decision by the FDA last week to clear the blood-derived treatment for emergency use.

    By Ned Pagliarulo • Sept. 2, 2020
  • A clinical trial participant is given Pfizer and BioNTech's experimental COVID-19 vaccine at the University of Maryland School of Medicine
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    Permission granted by University of Maryland School of Medicine
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    Healthcare workers likely to be first in line for coronavirus vaccination

    Initial vaccine supplies will be limited. Advisory groups, most recently the National Academies, are developing plans for who should get access first.

    By • Sept. 1, 2020
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    Courtesy of Sanofi
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    Sanofi ends research of arthritis drug as coronavirus treatment

    Kevzara failed to shorten hospital stays among patients severely sick with COVID-19, study results showed, further dimming hopes that drugs similar to it could help combat the disease.

    By • Sept. 1, 2020