Clinical Trials: Page 12
-
Kena Betancur via Getty Images
Keytruda fails lung and skin cancer trials, limiting further expansion
The trial setbacks for Merck’s best-selling drug, which faces patent expiration in 2028, are a blow to the company’s plans for further indication expansion.
By Jonathan Gardner • Aug. 29, 2024 -
Getty Images
Neurocrine’s mixed schizophrenia data disappoint Wall Street
Despite “positive” results, shares of the biotech slid by 20%. Analysts cautioned that Neurocrine shouldn’t get “the benefit of the doubt” with its data.
By Jacob Bell • Aug. 28, 2024 -
Explore the Trendline➔
Getty Images
TrendlineOncology'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 -
Getty Images
After an FDA rejection, here’s what’s next in the psychedelics pipeline
By rejecting the first MDMA therapy this month, the FDA signaled to the psychedelic drug field that the road to approval isn’t easy.
By Amy Baxter • Aug. 28, 2024 -
Getty Images
Sponsored by Worldwide Clinical TrialsRadiopharmaceutical trials: The critical role of site selection and support
Through effective collaboration, partnerships can accelerate the development of lifesaving therapies and improve patient outcomes.
Aug. 26, 2024 -
Getty Images
Avidity, Kymera raise fresh funds; Walgreens partners with BARDA
Avidity raised $345 million to advance development of RNA medicines designed to combine the advantages of oligonucleotides and antibodies.
By BioPharma Dive staff • Aug. 20, 2024 -
Getty Images
Lilly’s tirzepatide cuts diabetes risk, study data show
Treatment with the GLP-1 drug, which Lilly sells as Mounjaro and Zepbound, lowered the risk of Type 2 diabetes progression by 94% versus placebo.
By Ned Pagliarulo • Aug. 20, 2024 -
Thomas Lohnes via Getty Images
FDA lifts partial hold on study of BioNTech-partnered ADC
Partner MediLink Therapeutics is limiting the drug’s dosing after reports of lowered white blood cell counts and inflammation of the digestive tract.
By Jonathan Gardner • Updated Aug. 19, 2024 -
Jeenah Moon via Getty Images
Pfizer, BioNTech stumble in effort to develop combination flu, COVID shot
The vaccine didn’t spur a strong enough immune response against a particular flu strain in a Phase 3 trial, leading the companies to ponder adjustments.
By Delilah Alvarado • Aug. 16, 2024 -
Retrieved from Drug Enforcement Administration.
Following FDA rejection, a journal retracts papers on MDMA-assisted therapy
Editors at Psychopharmacology cited "unethical conduct" that the study authors didn't disclose when submitting the papers. Lykos Therapeutics says it filed a complaint with a third party to review the way the journal came to its decision.
By Jacob Bell • Aug. 12, 2024 -
Jeenah Moon via Getty Images
Pfizer builds case for RSV shot with data from immunocompromised adults
Results from a Phase 3 study could help Pfizer broaden use of its vaccine Abrysvo to younger adults whose medical history puts them at higher risk.
By Delilah Alvarado • Aug. 12, 2024 -
Courtesy of Apellis Pharmaceuticals
Apellis plans FDA filing after drug success in kidney trial
Analysts at Evercore ISI called pegcetacoplan’s data in two kidney conditions a “left-field hit” that compare favorably to results for a Novartis treatment.
By Ned Pagliarulo • Aug. 8, 2024 -
Getty Images
Obesity drugsLilly obesity drug shows heart benefit in late-stage trial
The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.
By Ben Fidler • Aug. 1, 2024 -
Drew Angerer via Getty Images
Pfizer’s Bourla confident in company’s obesity drug position, despite delays
The CEO noted how Pfizer's danuglipron could still be the second oral GLP-1 treatment to enter registrational tests after Lilly's orforglipron.
By Jonathan Gardner • July 30, 2024 -
Getty Images
Ventyx’s TYK2 drug suffers second setback
The company claimed “higher than anticipated” scores from trial volunteers on placebo led to the disappointing data, prompting it to halt internal trials.
By Jonathan Gardner • July 29, 2024 -
Getty Images
NewAmsterdam heart drug hits trial goal, but data appear to disappoint investors
The study is the latest test of a class of cholesterol medicines known as CETP inhibitors, which were abandoned by several large drugmakers last decade.
By Ben Fidler • July 29, 2024 -
Elizabeth Regan/BioPharma Dive
Viking shares jump on plans to speed obesity drug into late-stage testing
The drug’s advancement continued what one analyst described as a “torrid” pace for Viking’s closely watched medicine, which started human testing in 2022 and could reach a Phase 3 trial next year.
By Kristin Jensen • July 25, 2024 -
Permission granted by Biogen
Biogen, Sage tremor drug fails key trial
Known as SAGE-324, the drug was one of the key assets Biogen gained rights to through a billion-dollar research deal inked back in 2020.
By Jacob Bell • July 24, 2024 -
Kena Betancur via Getty Images
Merck claims late-stage study success for RSV antibody
The drug, a rival to Sanofi and AstraZeneca’s fast-selling Beyfortus, met its main goals in a Phase 3 trial. But undisclosed study results leave its full potential unclear.
By Ben Fidler • Updated July 23, 2024 -
Getty Images
Ionis plots next steps for Angelman drug Biogen passed on
The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.
By Jacob Bell • July 22, 2024 -
Courtesy of Roche
Obesity pill from Roche shows promising weight loss in small study
Treatment led to "clinically meaningful" weight loss over four weeks, but longer studies will be needed to compare it to Wegovy and Zepbound.
By Jonathan Gardner • July 17, 2024 -
Getty Images
Lexeo gene therapy shows signs of heart benefit in small study
The biotech, which went public late last year, argued the results justify exploring an accelerated approval. But shares fell by double digits amid investor skepticism.
By Ben Fidler • July 15, 2024 -
Getty Images
UniQure stock surges on data for Huntington’s gene therapy
The biotech’s stock rose more than 60% as fresh data appeared to alleviate some investor concerns about the therapy’s effectiveness and reliability.
By Jacob Bell • July 9, 2024 -
Joe Raedle via Getty Images
HilleVax’s norovirus vaccine ineffective in large trial of infants
Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study.
By Delilah Alvarado • July 8, 2024 -
Kendall Davis/BioPharma Dive
Deep Dive10 clinical trials to watch in the second half of 2024
Study results are expected for two closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.
By BioPharma Dive staff • July 1, 2024 -
Getty Images
Novo nixes trial of blood pressure drug it bought in $1.3B deal
The failure of a Phase 3 study led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.
By Jonathan Gardner • June 26, 2024
Previous
