Boehringer Ingelheim revealed new results from its Phase IIb EFFIOSAYIL 2 trial that shows its new antibody-based therapeutic Spevigo can prevent flare-ups in a rare and severe form of psoriasis, generalized postular psoriasis (GPP). The drug is the first treatment to be approved for the disabling […]
Bristol Myers Reveals Positive Phase II Data for Leukemia CAR-T Cell Therapy Breyanzi
Bristol Myers Squibb has announced new clinical trial data for its leukemia CAR-T cell therapy Breyanzi. The data shows that the therapy has met its primary endpoint in the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL), beating standard care in complete […]
J&J and Legend’s CAR-T Therapy Better Than Standard Care in Phase III Trial
J&J and Legend Biotech have announced new results from their CARTITUDE-4 trial that shows their new CAR-T therapy Carvykti is more effective at treating multiple myeloma than standard care. The companies say that the therapy, which many predict to be an upcoming blockbuster, has achieved the […]
Verana Health Publishes Real-World Data Ophthalmology Study Replicating Phase III Trials
Verana Health has announced the publication of its research in Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina. The study used de-identified real-world data (RWD) and replicated two phase III trials for the use of Regeneron in wet age-related macular degeneration, making it the first of its […]
Nature Medicine Perspective: Next-Gen Evidence-Based Medicine
The recent wave of digital health solutions, data analytics, and artificial intelligence (AI) is driving the newest generation of evidence-based medicine, according to a Nature Medicine perspective by Vivek Subbiah. These technologies are empowering novel clinical trials that utilize real-world […]
Improving Recruiting of Black and Rural Patients
In the US, Black and rural residents are often significantly underrepresented in clinical trials. This negatively impacts these populations and decreases the clinical potential of new therapeutics. In a recent Clinical Leader article, Chief Editor Ed Miseta discusses the underlying causes of […]
GAO Report Finds Certain Demographics Underrepresented in Cancer Drug Trials
A newly released report from the US Government Accountability Office finds that, despite years of health equity efforts, several key demographics are routinely underrepresented in clinical trials for new cancer therapeutics. This includes people with lower-incomes, rural residents, teens, older […]
Making Clinical Trials Populations Better Represent Patients
Clinical trial participants are often not representative of the patient populations. People from marginalized backgrounds are often overlooked, leaving lingering safety and efficacy questions remaining for those already facing barriers to access. In a new PM Live, article, Paul Chew of Phesi […]
Researchers Propose Novel Real-World Evidence Observational Study Design to Investigate Surgical Transfusion Complications
Observational evidence suggests that surgical transfusions are associated with increased complication risk, but randomized clinical trials (RCTs) have yet to identify such a phenomenon. In a newly published study in BMC Medical Research Methodology, researchers introduce an observational study […]
Eisai and Biogen’s Alzheimer’s Drug Surrounded by Cost and Safety Worries
As Eisai and Biogen’s novel Alzheimer's drug lecanemab inches closer to the finish line, many worry that the high price of the antibody-based therapeutic may lower patient access. A primary concern is whether payers will cover lecanemab, especially after the aduhelm controversy over the past few […]
