Clinical Trials: Page 15
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Obesity drugsDrugmakers are racing to find the next Wegovy. These obesity trials are ones to watch.
Amgen’s MariTide readout Tuesday was the first domino to fall in a series of data readouts that could reshape expectations for the weight loss drug market.
By Jonathan Gardner • Updated Nov. 26, 2024 -
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Sage continues downslide as Alzheimer’s study fails
After a series of setbacks for dalzanemdor, some analysts now expect that Sage won’t reach profitability for awhile — and only if its cost structure undergoes significant changes.
By Jacob Bell • Oct. 8, 2024 -
Explore the Trendline➔
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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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Scholar Rock scores with ‘surprise’ success in SMA drug study
Phase 3 findings could position the biotech’s therapy to become part of a “new standard” for SMA, its CEO said, while boosting research into whether it can preserve muscle in people with obesity.
By Ben Fidler • Oct. 7, 2024 -
AdobeStock/Rostislav Sedlacek
Sponsored by Advanced ClinicalBest practices for developing safety profiles in rare disease trials
The development of cancer vaccines has provided some hope in the battle against cancer worldwide; however, there are still many challenges to overcome when developing these life-saving treatments.
By David Turner, Senior Director of Global Safety Services • Oct. 7, 2024 -
Permission granted by MilliporeSigma
Sponsored by MilliporeSigmaAn effective analytical testing strategy for viral vectors should include these 7 steps
Producing safe, effective, high-quality viral vector therapeutics depends on a robust and tailored analytical testing strategy.
Oct. 7, 2024 -
Courtesy of Roche
Roche turns to a startup in search for new breast cancer drugs
The Swiss pharma is paying Regor Therapeutics $850 million to buy a pair of prospects it sees as potential successors to blockbuster medicines from Pfizer and Eli Lilly.
By Jonathan Gardner • Sept. 30, 2024 -
Permission granted by Thermo Fisher Scientific
Sponsored by Thermo Fisher ScientificAccelerating precision oncology: The value of an end-to-end partner for therapeutic access
Learn how optimal NGS solutions can help developers overcome challenges throughout targeted therapeutic development and the value of an end-to-end partner to help every step of the way.
Sept. 30, 2024 -
Courtesy of Bristol Myers Squibb
Struggling 2Seventy scraps a key cancer study
The biotech expects that stopping enrollment for KarMMa-9, a trial evaluating early use of the multiple myeloma cell therapy Abecma, should save it $80 million in the near term.
By Jacob Bell • Sept. 25, 2024 -
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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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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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