Clinical Trials: Page 16
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Summit lung cancer drug shows ‘striking’ benefit over Keytruda
Detailed study results backed up Summit's claim that its drug "decisively beat" Merck's dominant immunotherapy in a first-of-its-kind finding.
By Ben Fidler • Updated Sept. 8, 2024 -
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GSK antibody drug reduces COPD attacks in trial
New trial results could offer support for an expansion of Nucala’s label after U.S. regulators rejected GSK’s submission in 2018.
By Kristin Jensen • Sept. 6, 2024 -
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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 -
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Lilly builds case for weekly insulin shot
New data show Lilly’s longer-lasting insulin matched daily shots in controlling blood sugar, adding to positive findings the company disclosed in May.
By Jonathan Gardner • Sept. 5, 2024 -
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Deep DiveA decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology
Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.
By Jonathan Gardner • Sept. 4, 2024 -
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Vaxcyte’s “best-case” data for pneumococcal vaccine boost shares
The company's value jumped by several billion dollars as trial results showed its experimental shot could match and, in some cases, even outperform Pfizer's market-leading Prevnar 20.
By Delilah Alvarado • Sept. 3, 2024 -
Permission granted by Recursion Pharmaceuticals
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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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
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