Clinical Trials

  • A photo of Sanofi headquarters in Paris, France.
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    Courtesy of Sanofi

    Sanofi, Regeneron surge as Dupixent scores in COPD trial

    The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.

    By March 23, 2023
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    sudok1 via Getty Images

    Karuna’s schizophrenia drug succeeds in a second late-stage trial

    The results add to a growing body of evidence that Karuna’s drug, known as KarXT, could be a valuable new option for patients living with the brain disorder.

    By Updated March 20, 2023
  • Trendline

    Oncology's research boom

    More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

    By BioPharma Dive staff
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    Permission granted by West Pharmaceutical Services
    Sponsored by West Pharmaceutical Services

    Early decisions to de-risk the transition to combination products

    Speeding up the drug development process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing. 

    March 20, 2023
  • A photo of Takeda president of R&D Andy Plump.
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    Permission granted by Takeda

    Takeda, chasing Bristol Myers, unveils awaited TYK2 drug data

    "This is why we did the deal," said Takeda R&D chief Andy Plump, referring to his company's $4 billion acquisition of the medicine from startup Nimbus Therapeutics.

    By March 18, 2023
  • A wall showing a Merck & Co. logo in Kenilworth, New Jersey
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    Courtesy of Merck & Co.

    Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

    The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo.

    By March 17, 2023
  • woman wearing a lab coat and gloves working on a desktop computer
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    Permission granted by Open Clinica
    Sponsored by OpenClinica

    Clinical trial researchers are burned out too. Automated data capture is helping.

    Manual data transcription increases clinical research coordinator burnout. There is a better way.

    By Ben Baumann, OpenClinica Co-Founder and COO • March 13, 2023
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images

    FDA advisers back earlier use of Roche lymphoma drug

    The positive vote comes despite doubts from FDA scientists and increases the chance that Polivy could soon be approved as a first-line treatment alongside a drug regimen called R-CHOP.    

    By March 10, 2023
  • Beta-Amyloid Plaques and Tau in the Brain
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    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.

    Lilly reaches end of the road with long-studied Alzheimer’s drug

    Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease.

    By March 9, 2023
  • A medical Illustration showing lung cancer or bronchial carcinoma.
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    Mohammed Haneefa Nizamudeen via Getty Images

    AstraZeneca builds on study successes in early lung cancer

    The pharma’s drug Tagrisso extended survival in a trial that stirred debate at ASCO three years ago, while its immunotherapy Imfinzi reduced the risk of relapse in a different study.

    By March 9, 2023
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    Jolygon via Getty Images

    With PCSK9 pill, Merck aims to succeed where others failed

    The company is planning an ambitious Phase 3 program testing its oral cholesterol-lowering drug, which in a mid-stage trial appeared to match the effects of approved injectable competitors.

    By March 7, 2023
  • A wall showing a Merck & Co. logo in Kenilworth, New Jersey
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    Courtesy of Merck & Co.

    Merck drug data suggest ‘new direction’ for rare blood vessel disease

    Treatment with Merck’s sotatercept helped improve the exercise capacity of patients with pulmonary arterial hypertension, anticipated results from a Phase 3 study showed.

    By March 6, 2023
  • An anatomical model of the heart sits on a desk in a doctor's office
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    Ivan-Balvan via Getty Images

    Esperion shares sink on highly anticipated heart drug results

    The company says the findings could spur wider adoption of its pill Nexletol, though shares fell 20% as the data was short of Wall Street expectations.

    By March 6, 2023
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    maciek905 via Getty Images

    BridgeBio shares jump on dwarfism drug data

    The results impressed analysts and suggest the biotech's drug could become a threat to BioMarin's Voxzogo, sending shares up about 60%.  

    By Kristin Jensen • March 6, 2023
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    Sponsored by Kroger Health

    Kroger Health works to expand access to clinical trials

    Kroger Health seeks to increase awareness among more eligible clinical trial participants.

    March 6, 2023
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    Exelixis, Inc.

    Exelixis reports trial failure for cancer drug combination

    The setback is the second for the pairing of Cabometyx and Roche’s immunotherapy Tecentriq, dimming Exelixis’ hopes of further expanding its drug’s use before a key patent expires.

    By March 3, 2023
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    Permission granted by Veeva Systems

    Despite study setback, a biotech plans to push tremor drug into late-stage testing

    An experimental medicine from Praxis Precision Medicines missed the main goal of a Phase 2b trial. But there were also some positive findings, which have encouraged the company to press forward.

    By March 3, 2023
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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    Sarah Silbiger via Getty Images

    FDA asks advisers to review Lynparza amid growing scrutiny of PARP drugs

    The meeting to discuss Lynparza's use as a frontline treatment for prostate cancer follows a string of withdrawals for drugs in its class, and evidence it didn’t meaningfully extend survival in late-stage testing.

    By March 2, 2023
  • Exterior sign of Bristol-Myers Squibb
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    Permission granted by Bristol-Myers Squibb

    Bristol Myers, J&J plan tests of new blood thinner in nearly 50,000 patients

    The Phase 3 program for their medicine, milvexian, will be among the largest in drug development and almost twice the size of what Bayer has planned for a competing treatment.

    By Kristin Jensen • March 2, 2023
  • A vial of Merck & Co.'s cancer drug Keytruda next to its box.
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    Courtesy of Merck & Co.

    Merck reports two Phase 3 study misses for Keytruda

    The negative results in prostate and lung cancer are rare trial failures for the immunotherapy, and could limit expanded use of the drug in treating those tumor types.

    By Feb. 28, 2023
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    Leonid Sorokin via Getty Images

    Following another trial failure, a brain biotech considers ‘strategic alternatives’

    Aptinyx has joined a lengthy list of drugmakers looking to cut costs and explore strategic options after hitting setbacks in key clinical studies.

    By Feb. 28, 2023
  • Intellia Therapeutics headquarters in Cambridge, MA
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    Courtesy of Intellia Therapeutics

    Sickle cell pipeline narrows as gene therapy developers rethink research plans

    Graphite Bio and Sangamo are stopping work on their respective sickle cell gene therapies, while Intellia revealed partner Novartis ended development of its genetic treatment for the blood disease.

    By Feb. 23, 2023
  • A wall showing a Merck & Co. logo in Kenilworth, New Jersey
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    Courtesy of Merck & Co.

    Merck’s COVID-19 treatment falls short in prevention study

    The antiviral Lagevrio did not significantly reduce the risk of getting COVID-19 following household exposure to someone infected by the coronavirus.

    By Feb. 21, 2023
  • A sign for Pfizer is seen outside the Pfizer headquarters on November 9, 2020 in New York City.
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    David Dee Delgado via Getty Images

    Pfizer makes case for PARP-blocking drug in prostate cancer

    Full study results, revealed Thursday, could help Pfizer’s Talzenna win approval in the tumor type and compete with AstraZeneca’s rival medicine Lynparza.

    By Feb. 17, 2023
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    Erik Karits via Getty Images

    Pfizer, Valneva remove half of participants from study of Lyme disease shot

    Violations of study standards by a “third-party clinical trial site operator” prompted the partners to stop evaluating a large portion of the volunteers in their trial, the largest test of a Lyme disease vaccine in decades.

    By Feb. 17, 2023
  • A general view of the Pfizer Headquarters sign on November 10, 2020 in Tadworth, England.
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    Dan Kitwood via Getty Images

    Pfizer begins plan to challenge Shingrix with an mRNA vaccine

    The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine.

    By Feb. 10, 2023