News

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, highlights how FDA’s multiregional clinical trials in oncology guidance encourages more diverse site locations and patient populations.

Talzenna (talazoparib) with Xtandi (enzalutamide) produced a statistically significant improvement in overall survival among patients with metastatic castration-resistant prostate cancer, regardless of mutation status, making it the first combination of a PARP inhibitor and ARPI to achieve these results.

In this video interview with ACT editor Andy Studna, Kashoki, SVP, global head of regulatory strategy, discusses the new draft guidance and its emphasis on proactive planning.

For advancement, pharma must focus on streamlining clinical operations.

KEYNOTE-689 trial shows Keytruda (pembrolizumab) produced significantly improved event-free survival and major pathological response in patients with resected, locally advanced head and neck squamous cell carcinoma, marking the first Phase III trial to show meaningful results with an anti-PD-1 therapy in both the neoadjuvant and adjuvant settings.

The role of the clinical research associate may be key in addressing challenges around the adoption of digital tools.

Twice-yearly lenacapavir, a long-acting HIV-1 capsid inhibitor, reduced HIV infections by 96% in the Phase III PURPOSE 2 trial while showing superior efficacy over daily Truvada.

In this video interview with ACT editor Andy Studna, Erin Erginer, director of product, Certara looks forward and shares her insights on the future of data management.

Emergex’s T cell-priming candidate will be studied in early-phase trials in search for next generation of COVID-19 vaccines.

In this video interview with ACT editor Andy Studna, Erin Erginer, director of product, Certara discusses how improper data collection can extend timelines and incur additional cost.

CRO-sponsor relationships are key as industry moves towards new age of outsourcing.

In the Phase II PATH-HHT trial, pomalidomide significantly reduced the severity of epistaxis and improved quality of life in patients with hereditary hemorrhagic telangiectasia, offering a potential treatment for the bleeding disorder, which currently lacks FDA-approved therapies.

In this video interview with ACT editor Andy Studna, Erin Erginer, director of product, Certara touches on the burden associated with data collection.

The study will evaluate the safety and efficacy of a casdatifan plus volrustomig combination for the treatment of clear cell renal cell carcinoma.

Ziresovir is a potent, selective, orally bioavailable RSV F protein inhibitor, that has been shown to reduce viral load and the Wang Respiratory Score with a favorable safety profile in hospitalized infant patients with respiratory syncytial virus infection.

In this video interview with ACT editor Andy Studna, Erin Erginer, director of product, Certara discusses the lack of submission standards for clinical data.

Findings from two Baltimore medical centers presented at the American Society for Radiation Oncology Annual Meeting suggest spiritual themes and distrust may be behind the decline in trial participation.

Proof-of-concept Phase II ARTEMIS-UC trial shows efficacy of investigational humanized monoclonal antibody tulisokibart in treating inflammatory bowel disease compared with placebo.

In this video interview with ACT editor Andy Studna, Erin Erginer, director of product, Certara highlights challenges with data volume and complexity.

Webinar Date/Time: Tuesday, November 12th, 2024 at 10am EST | 7am PST | 3pm GMT | 4pm CET

Industry is turning to enhanced data collection methods in response to high demands for efficiency and profitability.

Beqvez (fidanacogene elaparvovec), a one-time gene therapy, was approved by the FDA in April 2024 to treat adults with moderate to severe hemophilia B.

In this video interview with ACT editor Andy Studna, Rich Gliklich, founder of OM1 highlights personalized medicine and predicting disease outcomes.

Recent study compared patient enrollment trends in industry- and federally sponsored oncology trials.

Results from the Phase III CARTITUDE-4 trial show Carvykti (ciltacabtagene autoleucel) is the first and only cell therapy to show an overall survival benefit compared to standard therapies for patients with relapsed or lenalidomide-refractory multiple myeloma.

In this video interview with ACT editor Andy Studna, Rich Gliklich, founder of OM1 discusses automating data collection and organizing unstructured data.

Phase III REGENCY trial results highlight potential of Gazyva/Gazyvaro (obinutuzumab) to improve outcomes in lupus nephritis patients, reducing progression to end-stage kidney disease.

Stakeholders are increasingly turning to data monitoring committees for better oversight.