Clinical Trials: Page 25
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A young biotech’s shares soar on early psoriasis drug results
Study data from Dice Therapeutics, which went public just a year ago, suggest its experimental pill has a chance to challenge marketed drugs from Amgen and Bristol Myers.
By Jonathan Gardner • Oct. 11, 2022 -
yodiyim via Getty Images
Merck cardiovascular drug succeeds in study, validating $11B buyout bet
Late-stage study results showed sotatercept, which Merck acquired via its Acceleron deal, benefited patients with PAH. The drug could help Merck fill an expected gap in revenue when patents on Keytruda expire.
By Jonathan Gardner • Oct. 10, 2022 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
Cytokinetics pushes on with late-stage study of ALS drug
A monitoring committee recommended the mid-stage trial continue after reviewing preliminary results. The drug, called reldesemtiv, previously fell short in Phase 2.
By Ned Pagliarulo • Oct. 10, 2022 -
Peddalanka Ramesh Babu via Getty Images
Allogene starts first pivotal trials of an ‘off-the-shelf’ cell therapy for cancer
The biotech believes the two Phase 2 trials initiated Thursday can support approval applications for what could be the first allogeneic cancer cell therapy.
By Ben Fidler • Oct. 7, 2022 -
Courtesy of GSK
GSK immunotherapy matches Keytruda in lung cancer trial
The British drugmaker said a mid-stage study of its PD-1 inhibitor Jemperli alongside chemotherapy showed “positive headline” results, which it will present in full later.
By Kristin Jensen • Oct. 5, 2022 -
Pfizer says PARP inhibitor succeeds in prostate cancer study
AstraZeneca paved the way for PARPs in prostate cancer when it won an approval for Lynparza in advanced patients. Now Pfizer may have a combination treatment for earlier-stage disease.
By Jonathan Gardner • Oct. 4, 2022 -
Spencer Platt via Getty Images
KalVista stops work on rare disease drug over safety concerns
The biotech terminated a Phase 2 study after treatment led to serious liver enzyme elevations in multiple patients with hereditary angioedema.
By Ned Pagliarulo • Oct. 4, 2022 -
Permission granted by Biogen
Biogen, Denali begin late-stage testing of Parkinson’s drug
Part of a $1 billion alliance the companies formed in 2020, the drug will be tested in a large study of patients who test positive for mutations in a gene called LRRK2.
By Jacob Bell • Oct. 3, 2022 -
Anne Callahan/BioPharma Dive
Sponsored by TD2 Precision Oncology[PODCAST] Evolution and Innovation in Oncology Therapeutics Development
The “Evolution and Innovation in Oncology Therapeutics Development” podcast series explores the role of multi-biomarkers in precision oncology.
By BioPharma Dive's studioID • Updated Sept. 11, 2023 -
koto_feja via Getty Images
Biohaven’s ALS drug comes up short in Mass General trial
Run by the hospital’s Healey Center, the platform trial is designed to evaluate several prospective treatments simultaneously and get answers on their potential more quickly.
By Kristin Jensen • Sept. 29, 2022 -
Kris Tripplaar/Sipa/Newscom
New Alzheimer's drugsWith little data to go on, experts question how useful Eisai, Biogen’s new Alzheimer’s drug will be
Positive results from a late-stage clinical trial of the drug, called lecanemab, were a surprising success for a field used to setbacks. But doctors and researchers point out that the reported benefit appears relatively modest.
By Jacob Bell • Sept. 29, 2022 -
Permission granted by Biogen
Biogen, Eisai data raises hope for other experimental Alzheimer’s drugs
Expectations are now higher for amyloid-clearing drugs from Eli Lilly and Roche after lecanemab showed it can slow the disease’s progression in a large Phase 3 clinical trial.
By Jonathan Gardner • Sept. 28, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
New Alzheimer's drugsIn surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial
The companies’ drug lecanemab met all of its goals in the Phase 3 study. The data were a significant finding and provided stronger support for a much-debated hypothesis for treating Alzheimer’s.
By Jonathan Gardner • Updated Sept. 27, 2022 -
Moyo Studio via Getty Images
Sponsored by MedscapeHealth equity: the current environment and a path to improvement
Over the last 2 years, a greater spotlight has shone on inequalities in health care, and the greater need to improve health equity.
Sept. 26, 2022 -
ismagilov via Getty Images
Pfizer, Sangamo set to resume gene therapy study after safety delay
Concerns over blood clotting risk had derailed testing of the hemophilia treatment last year, leading the companies to adjust their trial protocol.
By Delilah Alvarado • Sept. 23, 2022 -
Jolygon via Getty Images
AstraZeneca gives up on Ionis’ RNA drug for heart disease
The British drugmaker decided the medicine, which works similarly to Novartis’s Leqvio, wasn’t potent enough to justify further testing.
By Jonathan Gardner • Sept. 23, 2022 -
Kena Betancur via Getty Images
Merck to resume testing of closely watched HIV drug, but at lower dose
Safety concerns had derailed a slate of studies involving the drug, called islatravir, last fall. A partial FDA hold remains on any study using a higher dose.
By Ned Pagliarulo • Sept. 20, 2022 -
Christopher Furlong via Getty Images
AstraZeneca claims positive results for its “add-on” drug for rare blood disease
The drug, meant to complement other treatments for paroxysmal nocturnal hemoglobinuria, comes via Alexion, which had acquired it from Achillion in 2019.
By Delilah Alvarado • Sept. 16, 2022 -
Courtesy of Intellia Therapeutics
Intellia offers first look at CRISPR drug for rare swelling disorder
Preliminary study results show the biotech’s gene editing treatment could reduce markers and symptoms of hereditary angioedema, though the data come from few patients and follow-up remains limited.
By Ben Fidler • Updated Sept. 16, 2022 -
Spencer Platt via Getty Images
Pfizer reports success in trial of all-in-one meningitis vaccine
The company is planning an FDA submission as it works to expand its vaccine business beyond top-selling shots for COVID-19 and pneumonia.
By Jonathan Gardner • Sept. 15, 2022 -
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Akero shares soar as NASH drug succeeds in mid-stage trial
The biotech’s experimental medicine meaningfully improved multiple signs and symptoms of patients with NASH, a common liver disease that's proven a tough target for several drugmakers.
By Ben Fidler • Sept. 13, 2022 -
Retrieved from National Cancer Institute on September 27, 2019
Amgen data supports KRAS cancer drug, but survival benefit remains in question
Results from the company’s Phase 3 study show Lumakras outperformed chemotherapy. But that effect didn’t translate into patients living longer.
By Ned Pagliarulo • Sept. 12, 2022 -
Sarah Silbiger via Getty Images
FDA names new head to vaccine review office
David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters.
By Jonathan Gardner • Sept. 9, 2022 -
Regeneron answers rivals with data for new version of top-selling eye drug
A high-dose form of Eylea, administered less frequently, matched the original in late-stage testing, an important step in the company’s plan to defend its bestseller against competition.
By Ben Fidler • Sept. 8, 2022 -
Permission granted by Gilead Sciences
Gilead says its breast cancer drug helped patients live longer in study
The data could help Trodelvy secure a place in treatment, although a rival drug from Daiichi Sankyo and AstraZeneca will offer strong competition.
By Jonathan Gardner • Sept. 8, 2022
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