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This month, our review of recent clinical trial results features a drug for anemia due to chronic kidney disease that saw success after an FDA complete response letter, positive results for an ovarian cancer treatment and a hemophilia therapy as well as a lymphoma drug trial derailed by a serious adverse reaction.Read More
Clinical trial sites venturing into the growing field of digital therapeutics (DTx) need the appropriate infrastructure — as well as tech know-how and adaptability — while sponsors need to be willing to offer training and support, iron out hurdles that come with remote components and simplify these trials whenever possible, a clinical research expert advises. Read More
The level of Vitamin D3 in patients with melanoma has a significant effect on how those patients respond to chemotherapy with either Bristol Myers Squibb’s Opdivo (nivolumab) or Merck’s Keytruda (pembrolizumab). Read More
More than half of the best-selling brand-name drugs covered by Medicare may not provide significant added therapeutic benefits despite comprising a large portion of the federal agency’s spending, according to results of a study published in JAMA Network this week. Read More
Prolonged treatment time and maximum amyloid depletion appear key to slowing the cognitive decline of Alzheimer’s disease, researchers reported at the International Conference on Alzheimer’s & Parkinson’s Disease earlier this month. Read More
Prescription drug advertising is “highly complex” and warrants additional research to assess users’ understanding of the data displays and the “beneficial effect” of the disclosures, says a new study. Read More
When combined with Merck’s Keytruda (pembrolizumab), Moderna’s personalized messenger RNA (mRNA) vaccine 4157/V940 cut the risk of recurrence or death by 44 percent in patients with resected stage III/IV melanoma, relative to Keytruda alone.
In an effort to increase industry dialogue around best practices for benefit-risk assessments, AstraZeneca (AZ) has publicly shared the structured benefit-risk (sBR) assessment framework it employs across its drug development process. Read More
The forum will consider the impact of potential treatments by “refining existing measurement tools that clinical research has shown may not always adequately assess a drug’s effectiveness,” the FDA says. Read More
GOTHENBURG, SWEDEN — The approval of two Alzheimer’s disease-modifying therapies is giving the field a much-needed shot in the arm, experts said during a panel discussion at the Alzheimer’s and Parkinson’s Disease 2023 meeting. Read More