Clinical Trials


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    Permission granted by Biogen

    Medicare proposes to limit coverage of Biogen Alzheimer's drug

    The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in rigorous clinical trials, likely forestalling broader adoption of the treatment.

    By , Updated Jan. 11, 2022
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    cgtoolbox via Getty Images

    Allogene cleared by FDA to resume 'off the shelf' cancer cell therapy trials

    A "chromosomal abnormality" that led regulators to halt Allogene's trials was judged to be unrelated to its technology, a finding with important implications for the field of donor-derived cell therapies.

    By Jan. 10, 2022
  • Explore the Trendline
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
    Trendline

    Inside the race to bring coronavirus vaccines to the world

    More than a dozen shots are cleared for use in some fashion around the world. Producing enough supply and addressing the spread of coronavirus variants are the next challenges. 

    By BioPharma Dive staff
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    ismagilov via Getty Images

    BioMarin plans return to FDA with updated data on hemophilia gene therapy

    Two-year results from a Phase 3 study of Roctavian show treatment prevented bleeding, potentially giving BioMarin the data it needs to resubmit an application for approval. 

    By Updated Jan. 10, 2022
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    shapecharge via Getty Images
    Sponsored by FedEx

    Leveraging print and digital communications for patient-centric clinical trials

    The demand for communicating and reaching trial participants where they live in the most convenient and effective fashion is growing daily and having a dynamic print solution can help make that happen.

    Jan. 10, 2022
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    libre de droit via Getty Images

    Avrobio stops work on rare disease gene therapy after unexpected study results

    The biotech's gene therapy was one of the furthest along in testing for Fabry, a rare inherited disease that's become a target for drug developers.

    By Jan. 4, 2022
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    Kendall Davis/BioPharma Dive
    Deep Dive

    10 clinical trials to watch in the first half of 2022

    Biotech stocks ended 2021 in a slump. But positive results from eagerly anticipated studies in breast cancer, schizophrenia and Alzheimer's disease could help turn the sector's fortunes around.

    By Updated Jan. 6, 2022
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    Getty Images

    Allakos shares plunge as company's top drug falls short in studies

    The drug's effect in tissue did not appear to translate to a benefit in reducing symptoms, surprising executives at the biotech as well as its investors.

    By Kristin Jensen • Dec. 22, 2021
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    Permission granted by Gilead Sciences

    Gilead, following Merck, hits its own safety setback in HIV

    The FDA has halted all clinical trials testing the injectable form of Gilead's lenacapavir, for fear that incompatibility between the drug and the vials it's held in could cause contamination.

    By Dec. 22, 2021
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    Dr_Microbe via Getty Images

    Duchenne patient dies in Pfizer gene therapy study

    The tragic news follows changes Pfizer recently made to the design of another study testing the therapy due to side effects seen in some participants. 

    By Dec. 21, 2021
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    simonkr via Getty Images
    Sponsored by FedEx Office

    Supporting multi-audience communication in all stages of drug development

    Biopharmaceutical companies have ongoing and extensive needs for print and digital communications throughout the drug development life cycle that can benefit from a single-source vendor.

    Dec. 20, 2021
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    Spencer Platt via Getty Images

    EU regulator says member countries can use Pfizer's experimental COVID pill

    The European Medicines Agency is still reviewing Paxlovid but, citing fast increasing cases and deaths from COVID-19, offered flexibility to EU countries which may authorize emergency use.

    By Dec. 16, 2021
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    Biogen's new Alzheimer's drug

    Biogen reserves four years for trial meant to confirm its Alzheimer's drug works

    In granting approval, the FDA gave Biogen roughly nine years to run and submit results from an additional study of Aduhelm. Now, the company says it will do so in about half the time.

    By Dec. 16, 2021
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    Sanofi, GSK say COVID vaccine works as booster, but delay key study results

    The companies said their shot spurred increased immune responses in people who had received one of four widely used vaccines. But they still await long-anticipated data from a large Phase 3 study.

    By , Dec. 15, 2021
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    Novartis AG

    Two cancer cell therapy studies succeeded. Why did a third fail?

    Novartis' CAR-T drug Kymriah didn't appear better than standard of care in earlier lymphoma treatment. Its two similar rivals, Gilead's Yescarta and Bristol Myers' Breyanzi, did, raising questions about potential differences. 

    By Dec. 14, 2021
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    In final analysis, Pfizer's COVID-19 pill remains highly effective

    Full study results show Paxlovid cut the risk of COVID-19 hospitalization or death by about 90% among high-risk adults, matching the interim findings Pfizer disclosed last month.

    By Dec. 14, 2021
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    ismagilov via Getty Images

    Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug

    Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.

    By Dec. 14, 2021
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    Permission granted by The ALS Association
    Deep Dive // ALS drug development

    On the hunt for new ALS drugs, researchers see progress, and a long road ahead

    The fatal nerve disease has few treatments. But despite continued setbacks, drug developers are hopeful that genetic technologies and a better understanding of biology will bring new options in the not-too-distant future

    By Dec. 13, 2021
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    Gilead Sciences Inc.

    CAR-T therapy trials show promise for earlier use in lymphoma

    Study results presented at ASH suggest Gilead's Yescarta and Bristol Myers Squibb's Breyanzi could become replacements for stem cell transplants in treating the blood cancer.

    By Updated Dec. 13, 2021
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    Maddie Meyer via Getty Images

    Moderna reveals first study results for seasonal flu vaccine

    Data from a small Phase 1 trial showed the biotech's vaccine spurred immune responses to four common strains, although they didn't appear significantly greater than an already available shot from Sanofi.

    By Dec. 10, 2021
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    Courtesy of Roche

    Latest Roche results show promise for new type of cancer immunotherapy

    Updated Phase 2 data suggested an experimental drug targeting the protein TIGIT could bolster the benefit of Roche's Tecentriq in certain people with advanced lung cancer.

    By Dec. 10, 2021
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    ismagilov via Getty Images

    Fresh data show UniQure's hemophilia gene therapy appears to hold up

    The amount of blood clotting protein found in patients who received the medicine was nearly the same at six months and 18 months post-treatment, according to results disclosed Thursday.

    By Dec. 9, 2021
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    Vaccine from Medicago, GSK protective against COVID-19 in large study

    The vaccine, which Medicago plans to soon submit to Canadian regulators, would be the first of its type, though supply appears likely to be limited.

    By Dec. 7, 2021
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    Elizabeth Regan / Industry Dive

    Acadia shares rise on study success for Rett syndrome drug

    The biotech claims the results are enough to pursue an approval, but high rates of side effects and modest efficacy could raise questions about the treatment.

    By Dec. 7, 2021
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    Courtesy of Vertex Pharmaceuticals

    Vertex, needing research spark, finds promising results in small study of kidney disease drug

    The biotech, which has been stung by recent clinical setbacks, plans to soon advance the medicine into late-stage testing.

    By Dec. 1, 2021
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    cgtoolbox via Getty Images

    With safety a concern, Merck, Gilead pause study of HIV drugs

    Out of an "abundance of caution," the companies halted enrollment in a trial evaluating the combination of Merck's islatravir and Gilead's lenacapavir.

    By Nov. 24, 2021