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BTX-A51 aims to address GATA3 mutations, which affect around 15% of breast cancer patients.

A more user-centered design can allow increased flexibility in the development of eCOA platforms, driving better engagement and participation.

Results from both trials demonstrated a significant reduction in annual asthma exacerbations over 52 weeks.

ICON plc CEO Steve Cutler discussed how strategic partnerships are driving advancements in clinical trials.

Despite limitations to its widespread use within healthcare, there is great potential for ChatGPT’s application in drug development.

Results of the trial indicated that efsitora is non-inferior in A1C reduction compared to daily basal insulins.

Retrospective cohort study sought to identify similarities between response- and progression-based end points in clinical trials and weighted observational cohorts of patients.

Companies must be able to defend the fidelity and confidentiality of all records and data generated throughout a product’s entire lifecycle, starting with the earliest points in research.

Sotyktu (deucravacitinib; Bristol Myers Squibb) is an oral, selective, allosteric tyrosine kinase 2 inhibitor that produced clinically meaningful improvements in Psoriasis Area and Severity Index scores among adult patients with moderate-to-severe plaque psoriasis.

In the fifth and final part of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints look ahead to the future of risk-based quality management and what adoption will look like.

Once-weekly subcutaneous injection of CT-388 produced significant weight loss in healthy adults with obesity compared with placebo across 24 weeks in an early phase trial.

Promising scientific advances are pacing oncology drug development.

In part 4 of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints touch on what risks companies leave themselves susceptible to without the adoption of risk-based approaches.

Sharing an entertaining dive into the origins, milestones, and future of behavioral economics—where lessons can be applied to clinical practice.

Leqembi (lecanemab-irmb) was previously granted fast track designation by the FDA for a subcutaneous version of the drug to treat Alzheimer disease in patients with mild cognitive impairment or the mild dementia stage of the disease.

Expanded relationship will utilize Medidata’s artificial intelligence solutions.

The potential of PBPK modeling in answering key questions around these drugs.

In the Complete Response Letter to Dynavax, the FDA stated that the supplemental Biologic License Application based on findings from the Phase I HBV-24 trial lacked sufficient data to support a full evaluation of the efficacy or safety of a four-dose Heplisav-B regimen in adults on hemodialysis.

A forum of prominent industry stakeholders highlights the challenges for patients in navigating the multiple legal, regulatory, and ethical barriers to cross-border participation.

In part 3 of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints discuss what could be holding stakeholders back from adopting risk-based quality management.

Blockbuster cancer therapies failed to improve progression-free survival as combination.

Trial data met the pre-specified futility criteria for the primary endpoint of recurrence-free survival with the combination of vibostolimab and Keytruda (pembrolizumab) in the adjuvant treatment of patients with resected high-risk melanoma.

In part 2 of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints highlight what stood out to them from the results of a recent study on RBQM adoption.

The Tufts Center for the Study of Drug Development is gathering new benchmark data on the vendor qualification process including the time, cost, and resources required to qualify contract service and technology vendors.

Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease.

In part 1 of this video interview series with Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints, Getz touches on the findings from a recent study on RBQM adoption.

A survey conducted at this year’s Pistoia Alliance conference determined that although 70% of life sciences experts acknowledge artificial intelligence’s potential, many still struggle with its initiation and implementation.

A cohort study used county-level data on social determinants of health to examine their association with oncology study access.