BioSpace
SEPTEMBER 24, 2023
Recent drug approvals have shone a light on the role that patient advocacy groups can play in the regulatory process—but some experts have questions about the ethics of this influence.
JAMA Internal Medicine
SEPTEMBER 24, 2023
This cross-sectional study examines the expected prevalence of coronary artery calcium (CAC) on chest computed tomography (CT) in people without clinical atherosclerotic cardiovascular disease (ASCVD) by age, sex, and race and ethnicity.
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BioSpace
SEPTEMBER 24, 2023
The FDA’s briefing documents found that BrainStorm's BLA submission for its investigational cell therapy for ALS did not demonstrate evidence of effectiveness and that the manufacturing data was “grossly deficient.
JAMA Internal Medicine
SEPTEMBER 24, 2023
Screening tests are examinations performed on asymptomatic individuals to diagnose life-threatening medical conditions early enough to intervene to reduce disease-specific and overall mortality. Although the benefits of finding an unrecognized disease early in its course seem intuitive, screening tests and the clinical decisions based on them require testing with randomized clinical trials (RCTs) to understand the magnitude of benefit (if any) and the potential for harms including radiation, psy
BioSpace
SEPTEMBER 24, 2023
The losing streak continues for Merck and Eisai with their Keytruda-Lenvima combination failing to improve progression-free survival and overall survival in two late-stage lung cancer studies.
Drug Channels
SEPTEMBER 24, 2023
Drug Channels has just obtained new details on the size of the 340B Drug Pricing Program. I couldn’t wait to share the news, hence this special Sunday post. For 2022, discounted purchases under the 340B program reached a record $53.7 billion —an astonishing $9.8 billion (+22.3%) higher than its 2021 counterpart. The difference between list prices and discounted 340B purchases also grew, to $52.3 billion (+$2.6 billion).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
JAMA Internal Medicine
SEPTEMBER 24, 2023
This case report describes an older patient with persistent chest pain, recent hospitalization for SARS-CoV-2 infection, and previous kidney transplantation.
BioSpace
SEPTEMBER 24, 2023
Despite meeting the primary endpoint and eliciting endoscopic improvements in ulcerative colitis, Morphic Therapeutic’s investigational pill underwhelmed investors with its stock plummeting.
JAMA Internal Medicine
SEPTEMBER 24, 2023
This systematic review with meta-analysis examines the use of physical restraint use in adult emergency departments among patients of different racial and ethnic backgrounds.
BioSpace
SEPTEMBER 24, 2023
After dropping an early-stage study more than a year ago, AbbVie has finally terminated its CD47 collaboration with I-Mab, leaving up to $1.3 billion in potential milestone payments on the table.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Drug Patent Watch
SEPTEMBER 24, 2023
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Spain. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in Spain? appeared first on DrugPatentWatch - Make Better Decisions.
FDA Law Blog
SEPTEMBER 24, 2023
By Faraz Siddiqui — Every parent is familiar with the parade of horrors that accompany household items as mundane as window coverings. The cords that dangle from blinds are universally recognized as a grave danger to infants and children. It is also a hot-button issue for the U.S. Consumer Product Safety Commission (CPSC), the federal agency charged with monitoring and enforcing against dangerous consumer products.
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