Clinical Trials: Page 9
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AI specialist Recursion says lead drug is safe, but efficacy less clear
The Phase 2 results for Recursion’s treatment are the first in a series of important trial readouts for the high-profile “techbio” company.
By Ned Pagliarulo • Sept. 3, 2024 -
Sanofi finds a silver lining in mixed MS drug results
Tolebrutinib, which Sanofi acquired in a $3.7 billion deal, failed two studies in people with relapsing disease, but succeeded in a type of multiple sclerosis that has no approved therapies.
By Ben Fidler • Sept. 3, 2024 -
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 -
Full study data back Alnylam heart drug’s benefit, but leave doctors with tough choices
Shares of Alnylam fell as much as 9% amid skepticism vutrisiran hasn’t clearly shown it’s superior to other medicines for ATTR cardiomyopathy.
By Ben Fidler • Aug. 30, 2024 -
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 -
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 -
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 -
Sponsored by Worldwide Clinical Trials
Radiopharmaceutical 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 -
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 -
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 -
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 -
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 -
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 -
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 -
Obesity drugs
Lilly 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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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