Clinical Trials: Page 13
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Sponsored by LabConnectDon’t let your samples slip: Why every clinical trial needs biospecimen management
Assure the integrity and efficiency of your clinical trials with support from a Biospecimen Manager.
Oct. 28, 2024 -
del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
Intellia data spark debate about CRISPR drug’s potential
Newly published data show the therapy reduced the rate of swelling attacks in people with hereditary angioedema, but didn't silence questions about its commercial outlook.
By Kristin Jensen • Oct. 24, 2024 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
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Alto hits new low as depression drug flunks key test
While analysts still see value in Alto’s approach to brain drugmaking, investors may have lost some faith, as the biotech’s shares were down by two-thirds Wednesday morning.
By Jacob Bell • Oct. 23, 2024 -
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Otsuka’s startup bet pays off with kidney disease drug results
A medicine the pharma acquired in a 2018 buyout of Visterra succeeded in a Phase 3 trial in IgA nephropathy, a crowded corner of drug research.
By Ben Fidler • Oct. 22, 2024 -
Courtesy of Novo Nordisk
Oral version of Novo diabetes drug protects heart health in large study
The medicine, which Novo sells as Rybelsus, cut the risk of cardiovascular complications by 14% when added to standard therapies in people with diabetes and heart disease.
By Jonathan Gardner • Oct. 21, 2024 -
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Sponsored by AltasciencesPharmaceutical research on mRNA and CAR T-cell therapy in cancer: Pioneering the future of oncology
Immunotherapy and precision medicine show promise in better fighting cancer. What else does the research tell us?
Oct. 21, 2024 -
Kena Betancur via Getty Images
Merck antibody reduces RSV-related disease, hospitalizations in trial
Detailed data from a Phase 2b/3 study of Merck’s treatment clesrovimab should support the company’s efforts to win approval by the 2025-2026 season.
By Delilah Alvarado • Oct. 18, 2024 -
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FDA puts Novavax flu vaccine trials on hold
The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.
By Delilah Alvarado • Oct. 16, 2024 -
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Wave sees RNA editing validation in early trial results
The data provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.
By Ben Fidler , Ned Pagliarulo • Oct. 16, 2024 -
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GSK says antibody drug succeeds in testing for chronic nasal condition
The company has set high expectations for depemokimab, which it is also advancing in three other inflammatory diseases, including asthma.
By Delilah Alvarado • Oct. 14, 2024 -
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Sponsored by PearsonSuccessful COA selection paves the path to drug development
Choosing the right clinical outcome assessments (COAs) is an important part of successfully advancing drug development and securing regulatory approval.
Oct. 14, 2024 -
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Sponsored by Thermo Fisher ScientificFrom maximizing recruitment to promoting diversity: How to deploy NGS technologies to achieve clinical trial success
Learn how the right NGS technology can enhance clinical research while supporting downstream efforts toward global commercialization.
Oct. 14, 2024 -
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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 -
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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 -
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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 -
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 -
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 -
Mario Tama via Getty Images
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 -
Christopher Furlong via Getty Images
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
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