Clinical Trials: Page 2

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    Sarah Silbiger via Getty Images

    FDA panel supports agency push to raise approval bar for certain cancer drugs

    Though agency advisers were hesitant to label an entire drug class, they backed the FDA's interest in demanding randomized trials of PI3 kinase-blocking drugs, a decision that could impact future research.

    By April 22, 2022
  • Bristol Myers scraps $2B Nektar partnership after trial failures

    The companies have halted testing in kidney and bladder cancer, one month after ending a skin cancer study. Nektar executives are now preparing plans to conserve cash.

    By April 18, 2022
  • Explore the Trendline
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    National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.

    Cell therapy

    Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches.

    By BioPharma Dive staff
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    AbbVie, Genmab, with new data, prep FDA application for dual-acting cancer drug

    Fresh trial results intensify competition with Roche to deliver the first lymphoma drug that marries antibody technology with an immunotherapy pathway.

    By April 14, 2022
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    Justin Sullivan via Getty Images

    FDA clears Gilead to restart some studies of top cancer drug

    The agency's OK is a needed reprieve for Gilead, whose dealmaking strategy in oncology has come under scrutiny from analysts and investors.

    By April 12, 2022
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    BioPharma Dive

    AACR 2022: NK cell promise, more TIGIT questions and extending CAR-T's reach

    This year's meeting on early cancer research featured promising study results from German biotechs BioNTech and Affimed as well as details from a "practice-changing" lung cancer trial.

    By , April 11, 2022
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    William Walker/BioPharma Dive
    Sponsored by Janssen Oncology

    [Podcast] Breaking Down Barriers: How Bladder Cancer Innovations Benefit Patients and Treatments for Other Diseases

    Recent breakthroughs in bladder cancer treatment are helping patients combat one major challenge to current options — the bladder permeability barrier. These treatments also have implications for other cancers and diseases. This podcast explains how.

    By BioPharma Dive's studioID • April 11, 2022
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    Courtesy of Vertex Pharmaceuticals

    Vertex gets positive trial results for non-opioid painkiller in boost to pipeline

    After several attempts at designing a drug for acute pain, Vertex has a candidate it's ready to take into late-stage testing following two successful Phase 2 studies.

    By March 31, 2022
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    Sarah Silbiger via Getty Images
    ALS drug development

    FDA advisers narrowly side against an experimental ALS drug, likely lowering its approval chances

    The panel of independent experts found clinical trial evidence generated by the drug's developer, Amylyx Pharmaceuticals, insufficient to establish the treatment's effectiveness.

    By Updated March 30, 2022
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.

    Adagio plans comeback for COVID drug, but is it too late?

    The biotech said it will ask the FDA for approval of its antibody treatment after positive results from two trials. But relatively few participants were exposed to omicron, potentially raising questions about its utility.

    By March 30, 2022
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    Roche's top immunotherapy prospect fails study in tough-to-treat lung cancer

    A drug regimen including Roche's closely watched tiragolumab didn't outperform standard treatment in its first large trial, a setback for therapies aimed at a protein called TIGIT.

    By March 30, 2022
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    Jeenah Moon via Getty Images

    Pfizer inflammatory disease drug hits goal in second study

    The drugmaker said etrasimod, an experimental medicine acquired via its Arena buyout, improved remission rates in the second of two studies meant to support its approval in ulcerative colitis.

    By March 29, 2022
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    Sarah Silbiger via Getty Images
    Deep Dive // ALS drug development

    How a long shot ALS drug came before the FDA

    A negative vote from independent experts appears to lower the chances of Amylyx's medicine winning FDA approval. Still, FDA officials have cited flexibility and noted the difficulty of its forthcoming decision. 

    By March 28, 2022
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    Permission granted by Biogen
    ALS drug development

    Biogen shelves ALS drug after early-stage trial failure

    The study setback raises questions over how well a type of genetic medicine can work in adults with central nervous system disorders like ALS.

    By March 28, 2022
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    Permission granted by Mateusz Bartkowiak (QIAGEN)
    Sponsored by QIAGEN

    How to accelerate reliable and novel answers with expert-curated biomedical and clinical data

    Accelerate your path to novel, reliable answers with expert-curated biomedical and clinical data.

    March 28, 2022
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    Sarah Silbiger via Getty Images

    FDA rebuffs MEI, Kyowa Kirin as another cancer drug class draws scrutiny

    The companies said the FDA is now requiring results from a randomized study in the latest sign the agency is raising the bar for accelerated approval of so-called PI3K inhibitors.

    By March 25, 2022
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    Spencer Platt via Getty Images

    Pfizer claims study success for drug key to Arena buyout

    Etrasimod, the basis of the $7 billion acquisition and a potential rival to Bristol Myers Squibb's Zeposia, has cleared the first of two trials in ulcerative colitis. 

    By Kristin Jensen • March 23, 2022
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    Sergio Flores via Getty Images

    Moderna, with new data, to seek clearance for COVID-19 vaccine in young children

    Study results showed two shots of Moderna's vaccine led to similar immune responses as has been observed in young adults, although protection versus omicron was modest. 

    By March 23, 2022
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    Elizabeth Regan / Industry Dive

    Argenx boosted by positive trial results for new shot

    An easier-to-take version of Vyvgart could help Argenx expand the drug's use in autoimmune disease, potentially adding to the biotech's appeal as an acquisition target.

    By March 22, 2022
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    Ryan McKnight, Vertex Pharmaceuticals Inc.

    Vertex plans path to FDA for top drug prospect

    After observing promising results in a small study, Vertex is moving ahead with a pivotal trial for a kidney disease drug that's become a key part of the company's efforts to grow beyond cystic fibrosis.

    By Updated March 22, 2022
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    SciePro via Getty Images

    How Merck's 'puzzling' results could impact immunotherapy's role in early lung cancer

    New study data add to evidence that checkpoint inhibitors can slow the return of lung tumors. But the results also leave doubt over how best to use the drugs.

    By March 17, 2022
  • With trial success in kidney disease, Lilly, Boehringer make case for broader use of diabetes drug

    The positive results are the latest evidence supporting a broader role for so-called SGLT2 inhibitors, which started out as diabetes medicines but have since shown promise in a range of metabolic diseases.

    By March 16, 2022
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    Elizabeth Regan / Industry Dive

    BridgeBio looks for comeback with trial results for muscular dystrophy drug

    Positive signs for the experimental treatment could help shore up investor confidence in BridgeBio after the December study failure of a drug for a rare heart condition.

    By March 14, 2022
  • Nektar, Bristol Myers drug combination fails in late-stage melanoma trial

    The trial results were the most significant setback for the companies' four-year-old partnership and will likely force Nektar to cut costs.

    By March 14, 2022
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    Courtesy of Sanofi

    Sanofi, with positive data in hand, to ask for approval of longer-lasting hemophilia therapy

    Patients with severe hemophilia A who were given the drug had, on average, less than one bleeding event over a year, results that Sanofi and partner Sobi believe will pass muster with regulators.

    By March 9, 2022
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    Dan Kitwood via Getty Images

    Pfizer to test COVID pill in children as vaccinations in US plateau

    Supplies of the drug, called Paxlovid, have become more available for adults in the U.S., which recently began rolling out a "test-to-treat" initiative likely to make use of Pfizer's pill. 

    By Kristin Jensen • March 9, 2022