Results 211 to 220 of about 809,443 (296)

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

Interplay Between Heart Failure Events, New-Onset Diabetes, and Finerenone in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. [PDF]

Diabetes Care
Ostrominski JW, Lu H, Claggett BL, Desai AS, Jhund PS, Henderson AD, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Pitt B, Brinker M, Schloemer P, Rohwedder K, McMurray JJV, Solomon SD, Vaduganathan M.   +17 more
europepmc   +1 more source

Developing medication independence: The experience of UK teenagers

British Journal of Clinical Pharmacology, EarlyView.
Aims There is a progression through childhood from being provided medications by caregivers to having to take responsibility for medications yourself, but little is known about when the transition of adolescents managing medicines begins. The aim of this study was to obtain a cross‐sectional sample of UK adolescents and when they become independent ...
Holly Hutchins, Charlotte King, Louis Bioletti, Tsegay Gebru, Alder Hey Research Ambassadors, Daniel B. Hawcutt   +5 more
wiley   +1 more source

Comment: Increased exacerbations and hospitalizations among Pi*MZ compared to Pi*MM individuals? [PDF]

Respir Res
Fromme M, Remih K, Strnad P.
europepmc   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Analysis on the hospitalization expenses structure and correlation degree of lung cancer: evidence from Shanxi Province, China. [PDF]

Front Public Health
Wu B, Jin M, Liu J.
europepmc   +1 more source

Completion vs. early discontinuation of chemotherapy and the impact on 5‐year all‐cause mortality in women treated for early‐stage breast cancer from 2015 to 2020: A cohort study using a target trial emulation approach

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Chemotherapy is given for early‐stage breast cancer; however, some patients discontinue before completing all planned cycles. This study investigated the impact of early chemotherapy discontinuation on treatment outcomes. Methods This retrospective cohort study used a target trial emulation framework to conduct a causal analysis of the all‐
Luke Steventon, Chengsheng Ju, Kenneth K. C. Man, Rebecca Roylance, Diego Ottaviani, Chiara Creed, Michal Sladkowski, Alec Wisner, Li Wei, Pinkie Chambers   +9 more
wiley   +1 more source

Nudges to Clinicians and Patients for Influenza Vaccines During Visits: The BE IMMUNE Randomized Clinical Trial. [PDF]

JAMA Intern Med
Mehta SJ, Waddell KJ, Linn KA, Brophy C, Liang J, Park SH, Reitz C, Williams K, Couzens C, Staloff J, White AA, Rhodes C, Liao JM, Navathe AS.   +13 more
europepmc   +1 more source

Early clinical pharmacology evaluation of the novel anti‐inflammatory macrolide, glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims This work assessed the pharmacokinetics (PK), safety and tolerability of glasmacinal (EP395, an oral anti‐inflammatory macrolide with negligible antimicrobial activity in development for COPD treatment) in two healthy participant trials: ‘first‐in‐human’ (FIH) and ‘drug–drug‐interaction’ (DDI).
Dave Singh, Kate Hanrott, Olof Breuer, Johan Bylund, Björn Schultze, Virginia Norris   +5 more
wiley   +1 more source