Clinical Trials: Page 3
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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 -
Explore the Trendline➔
Yelena Shander via Getty Images
TrendlineVaccine development
Vaccine developers are turning from COVID-19 to invest more heavily in shots for RSV, influenza and pneumococcal disease.
By BioPharma Dive staff -
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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 -
Carsten Koall via Getty Images
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 -
Christoph Burgstedt via Getty Images
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 -
Warren Little via Getty Images
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 -
Wasan Tita via Getty Images
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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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 -
Scott Olson via Getty Images
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 -
Stock via Getty Images
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 -
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 -
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 -
European Society for Medical Oncology
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 -
Win McNamee via Getty Images
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 -
FatCamera via Getty Images
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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