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Drug safety relates to the potential for adverse effects related to the administration of drugs. Efforts to establish the safely profile of drugs begin early in their development, with in vitro and in vivo toxicity testing, and continue through clinical trials leading up to drug approval and following approval in specific post-marketing studies or general pharmacovigilance efforts.
Whether switching from low-molecular-weight heparin to direct oral anticoagulants (DOACs) in cancer-associated thrombosis patients is safe and effective is unknown. Here, the authors show that switching to DOACs reduced venous thromboembolism and mortality without increasing bleeding.
Cryogenic electron microscopy structures of Mycobacterium tuberculosis ATP synthase and human ATP synthase bound to the anti-tuberculosis drug bedaquiline or its analogue TBAJ-587 shed light on drug binding and could lead to new treatments for tuberculosis.
In a phase 1 trial in a single patient with hereditary spastic paraplegia type 50, a personalized AAV9-based gene therapy was developed within 3 years from diagnosis and was well tolerated, showing preliminary evidence of disease stabilization.
The FDA approval of perioperative pembrolizumab, an approach that combines neoadjuvant and adjuvant therapy with this agent, for patients with early stage non-small-cell lung cancer (NSCLC) contradicts its own stated standard for combination therapies. Given the large population of patients with early stage NSCLC and the high costs of pembrolizumab, whether the adjuvant component provides incremental benefit is an important question.
In this Comment, Berna Özdemir summarizes the evidence for greater drug toxicity in female patients and emphasizes the need for increased awareness of sex differences at all stages of drug development to establish sex-specific anticancer treatment strategies.
An international security conference explored how artificial intelligence (AI) technologies for drug discovery could be misused for de novo design of biochemical weapons. A thought experiment evolved into a computational proof.
This study presents the results of a respiratory syncytial virus (RSV) challenge trial with EDP-938, a nonfusion replication inhibitor of RSV, showing effective lowering of viral load and symptoms, without apparent safety concerns.