Clinical Trials: Page 11
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Amgen claims success for two immune drugs, but results underwhelm Wall Street
Medicines the company is developing for eczema and myasthenia gravis met their objectives in Phase 3 trials. But analysts weren’t convinced they can compete with available alternatives.
By Kristin Jensen • Sept. 25, 2024 -
Permission granted by Biogen
Biogen, UCB get the lupus data they’ve waited two decades for
The companies now plan on starting this year another large study of their medicine, dapirolizumab pegol, in the hopes that they can confirm its safety and effectiveness to drug regulators.
By Jacob Bell • Sept. 24, 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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AstraZeneca, Daiichi’s Enhertu successor faces more questions after latest stumble
The partners said their antibody-drug conjugate datopotomab deruxtecan didn’t extend survival in a breast cancer study, fueling additional doubts about its approval prospects.
By Jonathan Gardner • Sept. 23, 2024 -
Courtesy of Biohaven Ltd.
After setback, Biohaven to seek approval of neurological disorder drug
With fresh, positive data in hand, Biohaven now believes its medicine could be the first to receive FDA approval for spinocerebellar ataxia.
By Jacob Bell • Sept. 23, 2024 -
Courtesy of Merck & Co.
ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial
The FDA previously rejected patritumab deruxtecan over manufacturing issues. Tuesday's study data should boost the companies' case, however.
By Jonathan Gardner • Sept. 17, 2024 -
ESMO24: A cancer cachexia drug, VEGF enthusiasm and immunotherapy’s survival impact
Results for Pfizer’s ponsegromab looked promising, while BioNTech and Instil Bio capitalized on momentum surrounding a kind of bispecific antibody.
By Ned Pagliarulo , Jonathan Gardner • Sept. 16, 2024 -
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As Biosecure bill advances, drugmakers prepare for prospect of China pivot
While companies’ exposure to the Biosecure Act varies, drugmakers are bracing for the knock-on effects that its passage could create in the market for contract services.
By Amy Baxter • Sept. 16, 2024 -
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Sponsored by Worldwide Clinical TrialsAccelerating the new wave of CAR T therapy trials
Applying CAR T-cell therapy in new clinical settings presents unique challenges. Worldwide Clinical Trials is at the forefront, partnering with drug development teams to map this new path forward.
Sept. 16, 2024 -
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Sponsored by FortreaBridging science and humanity: How systems thinking should shape clinical trial execution
Applying a systems thinking approach can create improvements in scientific integrity, operational feasibility and scalability.
By Tetyana Korchak, MD - Global Lead & Executive Director, Strategic Delivery & Growth, at Fortrea • Sept. 16, 2024 -
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Ten-year survival data show long-term benefit of immunotherapy in melanoma
“It’s a real opportunity to reinforce hope and to start getting comfortable with the word ‘cure,” said a leader of the study, which tested Opdivo and Yervoy.
By Jonathan Gardner • Sept. 15, 2024 -
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TIGIT drug from iTeos shrinks lung tumors in trial
Results presented at ESMO showed tumor response rates that matched the bar set by analysts for success. But they may not yet be enough to dispel doubts around TIGIT as a target.
By Ned Pagliarulo • Sept. 14, 2024 -
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Fulcrum shares collapse as Sanofi-partnered muscular dystrophy drug fails key test
The biotech will now suspend development of a drug prospect that Sanofi acquired partial rights to just four months ago.
By Jonathan Gardner • Sept. 12, 2024 -
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Dupixent succeeds in chronic hives study, giving Sanofi, Regeneron a chance to rebound
Following an FDA rejection last year, the partners plan to resubmit their application for approval of Dupixent in chronic spontaneous urticaria.
By Kristin Jensen • Sept. 11, 2024 -
Permission granted by Centessa Pharmaceuticals
Investors are waking up to Centessa’s sleepiness drug
A small, early study produced what one analyst called “highly compelling” results that lifted the company’s shares by as much as 15% Tuesday.
By Jacob Bell • Sept. 10, 2024 -
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New data add to doubts about AstraZeneca, Daiichi’s Enhertu successor
The partners’ ADC didn’t significantly extend survival in lung cancer patients who were expected to benefit the most from treatment in a Phase 3 trial.
By Ben Fidler • Sept. 10, 2024 -
Permission granted by Relay Therapeutics
Relay breast cancer drug shows potential in early trial
Results from a small study suggest Relay's drug could avoid some of the toxicity associated with existing PI3Ka inhibitors like Novartis' Piqray.
By Ned Pagliarulo • Sept. 9, 2024 -
shutterstock.com/Juan Gaertner
Early study data puts Terns among obesity drug contenders
A once-daily pill the biotech is developing helped some people with obesity lose more than 5% of their weight in a month, spurring a stock bump and plans to bring the drug into further testing.
By Jonathan Gardner • Sept. 9, 2024 -
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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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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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