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Thirty-five years on from the FDA’s approval of a first monoclonal antibody, these biologics account for nearly a fifth of the agency’s new drug approvals each year.Thirty-five years on from the FDA’s approval of a first monoclonal antibody, these biologics account for nearly a fifth of the agency’s new drug approvals each year.

Long-term adverse experiences following psychedelic use can persist for weeks, months, or even years, and are relatively unexplored in psychedelic research. Our convergent mixed-method study gained quantitative and qualitative data from 608 participants who reported extended difficulties following psychedelic experiences. Data was gathered on the context of use, the nature and duration of the challenges they experienced (including a written description of these), plus a range of possible risk factors and perceived causes. The most common forms of extended difficulty were feelings of anxiety and fear, existential struggle, social disconnection, depersonalization and derealization. For approximately one-third of the participants, problems persisted for over a year, and for a sixth, they endured for more than three years. It was found that a shorter duration of difficulties was predicted by knowledge of dose, drug type and lower levels of difficulty reported during the psychoactive experience, while a narrower range of difficulties was predicted by taking the drug in a guided setting. Implications for psychedelic harm reduction are discussed.

The FDA approved 48 new drugs last year, keeping up the momentum of recent years.The FDA approved 48 new drugs last year, keeping up the momentum of recent years.

Cancer immunotherapies targeting adaptive immune checkpoints have substantially improved patient outcomes across multiple metastatic and treatment-refractory cancer types. However, emerging studies have demonstrated that innate immune checkpoints, which interfere with the detection and clearance of malignant cells through phagocytosis and suppress innate immune sensing, also have a key role in tumour-mediated immune escape and might, therefore, be potential targets for cancer immunotherapy. Indeed, preclinical studies and early clinical data have established the promise of targeting phagocytosis checkpoints, such as the CD47–signal-regulatory protein α (SIRPα) axis, either alone or in combination with other cancer therapies. In this Review, we highlight the current understanding of how cancer cells evade the immune system by disrupting phagocytic clearance and the effect of phagocytosis checkpoint blockade on induction of antitumour immune responses. Given the role of innate immune cells in priming adaptive immune responses, an improved understanding of the tumour-intrinsic processes that inhibit essential immune surveillance processes, such as phagocytosis and innate immune sensing, could pave the way for the development of highly effective combination immunotherapy strategies that modulate both innate and adaptive antitumour immune responses.

A comprehensive overview of medical AI devices approved by the US Food and Drug Administration sheds new light on limitations of the evaluation process that can mask vulnerabilities of devices when they are deployed on patients.

Background Accreditation is viewed as a reputable tool to evaluate and enhance the quality of health care. However, its effect on performance and outcomes remains unclear. This review aimed to identify and analyze the evidence on the impact of hospital accreditation. Methods We systematically searched electronic databases (PubMed, CINAHL, PsycINFO, EMBASE, MEDLINE (OvidSP), CDSR, CENTRAL, ScienceDirect, SSCI, RSCI, SciELO, and KCI) and other sources using relevant subject headings. We included peer-reviewed quantitative studies published over the last two decades, irrespective of its design or language. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, two reviewers independently screened initially identified articles, reviewed the full-text of potentially relevant studies, extracted necessary data, and assessed the methodological quality of the included studies using a validated tool. The accreditation effects were synthesized and categorized thematically into six impact themes. Results We screened a total of 17,830 studies, of which 76 empirical studies that examined the impact of accreditation met our inclusion criteria. These studies were methodologically heterogeneous. Apart from the effect of accreditation on healthcare workers and particularly on job stress, our results indicate a consistent positive effect of hospital accreditation on safety culture, process-related performance measures, efficiency, and the patient length of stay, whereas employee satisfaction, patient satisfaction and experience, and 30-day hospital readmission rate were found to be unrelated to accreditation. Paradoxical results regarding the impact of accreditation on mortality rate and healthcare-associated infections hampered drawing firm conclusions on these outcome measures. Conclusion There is reasonable evidence to support the notion that compliance with accreditation standards has multiple plausible benefits in improving the performance in the hospital setting. Despite inconclusive evidence on causality, introducing hospital accreditation schemes stimulates performance improvement and patient safety. Efforts to incentivize and modernize accreditation are recommended to move towards institutionalization and sustaining the performance gains. PROSPERO registration number CRD42020167863.