Clinical Trials: Page 2


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    Leonid Sorokin via Getty Images
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    Travere set back by study failure of kidney disease drug

    Shares in the biotech, formerly Retrophin, sank after the company disclosed its newly approved drug sparsentan failed a study meant to expand its use.

    By May 2, 2023
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    selvanegra via Getty Images
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    Alnylam’s early Alzheimer’s results encourage, but company discloses new hurdle

    Partner Regeneron said the data, which showed substantial reduction of a key protein, suggests hope for the “bold dream” of silencing genes in the brain.

    By Kristin Jensen • April 27, 2023
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    National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
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    Trendline

    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
  • A box of Eli Lilly's diabetes drug Mounjaro is held for a photo.
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    George Frey/Reuters

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    Obesity drugs

    Lilly drug Mounjaro succeeds in second weight loss study

    Trial participants nearly 16% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

    By April 27, 2023
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    Jacob Bell
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    Novartis trims 10% of drug pipeline in research cutback

    The company cut about 20 early-stage projects, including nine solid tumor programs, after reviewing their strategic fit and commercial potential.

    By April 25, 2023
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    Elizabeth Regan / Industry Dive
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    Morphic shares swing on study data for drug viewed as ‘oral Entyvio’

    Results from a small trial suggested Morphic's pill could be effective in treating inflammatory bowel disease, briefly lifting the company’s valuation by hundreds of millions of dollars. 

    By Updated April 25, 2023
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    Christopher Furlong via Getty Images
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    Ionis, AstraZeneca detail data backing rare disease rival to Alnylam drugs

    A second-generation treatment called eplontersen halted nerve damage and improved quality of life in a late-stage study the companies are using to seek U.S. approval.

    By April 24, 2023
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    iStock via Getty Images
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    Apellis’ immune system drug hits a setback in ALS

    The company has chosen to stop an extension portion of a key study after an external group of advisers reviewed the data available and concluded further treatment with the drug was unwarranted.

    By April 21, 2023
  • A photograph of an infusion bag of Carvkyti, J&J and Legend Biotech's cancer cell therapy
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    Permission granted by Johnson & Johnson
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    J&J study data show dramatic benefit to multiple myeloma cell therapy

    A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs.

    By April 19, 2023
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    Dr_Microbe via Getty Images
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    Vaxcyte strengthens case for experimental pneumococcal vaccine

    The company reported positive results from a second Phase 2 study of a shot that’s meant to challenge vaccines from Pfizer, Merck and GSK.

    By Updated May 3, 2023
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    Permission granted by Cardinal Health
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    Sponsored by Cardinal Health

    Navigate the complexities of cell and gene therapies

    See how the effective use of CMC expertise helped guide a biopharma company’s development of a CGT product.

    April 17, 2023
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    Photogeek, Photo by Drazen

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    Sponsored by OpenClinica

    Patient-centered clinical trials improve recruitment and retention

    Let’s face facts. Patient enrollment in clinical trials is time-intensive & costly. We must do better.  

    April 17, 2023
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    Maddie Meyer via Getty Images
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    Moderna, Merck data support claim of cancer vaccine’s promise

    Data presented at AACR suggest a personalized shot made with messenger RNA may amplify the effects of a widely prescribed cancer immunotherapy.

    By April 16, 2023
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    Maddie Meyer via Getty Images
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    New data raise more doubts about Moderna’s flu vaccine

    The shot appears to generate an immune response that matches or exceeds existing vaccines, but investigators aren’t yet sure how well it can prevent illness.

    By April 11, 2023
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    Marko Georgiev / Stringer via Getty Images
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    Merck, Eisai report pair of study setbacks for cancer drug combo

    Phase 3 trials testing Merck’s Keytruda with Eisai’s Lenvima in colon and skin cancers didn’t show a survival benefit, denting the partners’ plans to expand the drugs’ use.

    By April 7, 2023
  • Human respiratory syncytial virus virions are shedding from the surface of human lung cells.
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    National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
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    RSV vaccines

    In NEJM, full Pfizer data show RSV vaccine’s protection

    Shots from Pfizer and GSK could soon become the first approved for the common respiratory infection. Results published in the high-profile medical journal give a closer look at the former.

    By Updated April 6, 2023
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    koto_feja via Getty Images
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    Cytokinetics to end late-stage study of ALS drug

    The decision comes after an external group of advisers who got an interim look at the data found Cytokinetics’ drug had “no effect” on the study’s goals.

    By March 31, 2023
  • Human respiratory syncytial virus virions are shedding from the surface of human lung cells.
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    National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
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    J&J abandons RSV vaccine in major strategy shift

    The pharma, once a frontrunner in the race to develop the first vaccine for the respiratory virus, said it will end a 23,000-person study of its experimental shot amid a restructuring of its infectious disease division.

    By Updated March 29, 2023
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    iStock via Getty Images
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    Obesity drugs

    Viking joins obesity drug development race with early study data

    The biotech is working on a dual-acting weight loss treatment that could compete with medicines from Novo Nordisk, Eli Lilly and others.

    By March 28, 2023
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    Getty Images
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    Intra-Cellular shares rise on depression study’s success

    The biotech’s drug lumateperone scored in a late-stage study of patients with either bipolar or major depressive disorder — results which some analysts called a “clear win.”

    By March 28, 2023
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    Novartis 

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    Novartis, following Lilly, claims success in early breast cancer study

    The Swiss drugmaker believes the findings could support an approval of Kisqali in adjuvant breast cancer and, potentially, broader use than Lilly’s rival drug Verzenio.  

    By March 27, 2023
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell / BioPharma Dive
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    ALS drug development

    ALS drugmakers, encouraged by recent FDA feedback, set their sights on a key protein

    A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.

    By Updated March 31, 2023
  • A photo of Sanofi headquarters in Paris, France.
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    Courtesy of Sanofi
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    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
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    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
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    Permission granted by West Pharmaceutical Services
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    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
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    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