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FDA Moving to Nonanimal Testing Methodologies in Preclinical Research

Pharmacy Times

Image Credit: filin174 | stock.adobe.com The FDA’s plan first addresses monoclonal antibodies (mAbs) but eventually could be applied to all compounds seeking FDA approval. 3 More simply, the FDA is moving preclinical testing from in vivo animal models to in silico and in vitro methods.

FDA
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Dapagliflozin Improves Health Outcomes for Adolescents With Type 1 Diabetes

Drug Topics

Image Credit: WindyNight - stock.adobe.com "Our findings showed that adolescents who received this combination therapy were able to improve many symptoms typically associated with insulin-managed type one diabetes,” Farid Mahmud, MD, FRCPC, physician at The Hospital for Sick Children, said in a news release. October 18, 2016.

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New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

The 2016 World Health Organization classification of MCL recognizes 2 molecular subtypes that reflect divergent pathogenesis and clinical behavior 2 : Classical MCL is derived from naive B cells that lack somatic hypermutation in IGHV , do not transit through the germinal center, and express the SOX11 transcription factor.

FDA
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Pharmacists Push Forward: Innovative Clinical Solutions Highlighted at McKesson ideaShare 2025

Pharmacy Times

1 Howard’s team built their telehealth service in collaboration with hospitals and health systems, especially to tackle the issue of hospital readmissions for Medicare and Medicaid patients—each of which can cost hospitals thousands of dollars.

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Lumateperone Submits Application for Schizophrenia Indication to FDA for Supplemental New Drug

Pharmacy Times

Relapse risk factors include prior hospitalizations, long illness duration, and antipsychotic polypharmacy, emphasizing the need for effective maintenance treatments. Maintaining stability in schizophrenia is a major clinical challenge—each relapse can disrupt functioning, burden caregivers, and elevate hospitalization risk.

FDA
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Invest a Few Minutes in Inhaler Counseling

Pharmacy Times

6,7 Image Credit: Goffkein | stock.adobe.com A recent study examined inhaler use among 279 patients hospitalized for an exacerbation. 8 The researchers looked for critical technique errors and assessed the need to change the inhaler type at hospital discharge. Worldwide, roughly 730 million people have one of these diseases.

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Zanubrutinib Linked to Lower Infection Risk Than Venetoclax Plus Obinutuzumab in Real-World CLL/SLL Study

Pharmacy Times

1,2 To better understand this relationship, researchers assessed 4754 patients with CLL/SLL who were treated with either venetoclax and obinutuzumab from April 2016 to August 2022 (n = 2104) or zanubrutinib from November 2019 to August 2023 (n = 2650). 1 At 12 months, 7.9%