Era of surrogate endpoints and accelerated approvals: a comprehensive review on applicability, uncertainties, and challenges from regulatory, payer, and patient perspectives.

Purpose: The regulatory landscape in rare diseases and oncology has evolved to address unmet medical needs by implementing expedited approval pathways. The US FDA's Accelerated Approval and the EMA's Conditional Marketing Authorization facilitate earlier patient access to therapies through reliance on surrogate endpoints derived from early-phase clinical trials. The review aims to provide a comprehensive review of the role and utilization of surrogate endpoints in accelerated drug approvals, highlighting their strengths, limitations, and the varying perspectives of stakeholders on their validity and utility.

Assessment of utilization of nutritional support scheme vis a vis nutritional status of tuberculosis patients on nutritional support scheme.

Introduction: Tuberculosis and undernutrition is a well-known association and form a vicious cycle. A nutritional support scheme under the name of NIKSHAY POSHAN YOJANA (NPY) was launched in April 2018 where a direct bank transfer of INR 500 was made to the patients enrolled in the NIKSHAY portal monthly to support the nutritional needs of the patients. The study was undertaken to study the implementation and utilization of the benefit among tuberculosis patients.

Tuberculosis and stigma: Break the silence….

Stigma associated with tuberculosis (TB) and other diseases can have severe consequences on patient care and treatment outcomes. It is closely linked to social behaviour and deep rooted taboos.Stigma reduces trust in caregivers, leading to less attention to doctor's advice, lack of follow-up and poor adherence to treatment.

Nasal anti-CD3 monoclonal antibody ameliorates traumatic brain injury, enhances microglial phagocytosis and reduces neuroinflammation via IL-10-dependent T-microglia crosstalk.

Neuroinflammation plays a crucial role in traumatic brain injury (TBI), contributing to both damage and recovery, yet no effective therapy exists to mitigate central nervous system (CNS) injury and promote recovery after TBI. In the present study, we found that nasal administration of an anti-CD3 monoclonal antibody ameliorated CNS damage and behavioral deficits in a mouse model of contusional TBI. Nasal anti-CD3 induced a population of interleukin (IL)-10-producing regulatory T cells (T cells) that migrated to the brain and closely contacted microglia.

The Impact of Social Media for Hand Surgeons: A Prevalence and Correlation Study With Online and Academic Reputations.

Purpose: This study examines the influence of social media use among orthopedic and plastic-trained hand surgeons on patient-reported ratings online and academic productivity.

Methods: The American Society of Surgery of the Hand directory was queried for actively practicing orthopedic and plastic surgeons with a hand surgery fellowship. Each name was searched on various social media platforms.