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

Pharmacy Times

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Continuous Subcutaneous Lenalidomide Shows Promise in Reducing Toxicity in R/R Multiple Myeloma

Pharmacy Times

The study aimed to evaluate both safety and preliminary efficacy outcomes, with a specific focus on hematologic toxicity, pharmacokinetics, and immune system effects. Patients were trained to self-administer their infusion at home or attend clinic visits 3 times weekly.

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Daily CBD Use at Consumer-Level Doses May Elevate Liver Enzymes, FDA-Led Trial Shows

Pharmacy Times

Animal studies reveal dose-dependent hepatic responses to CBD, supporting the need for cautious monitoring even at consumer-relevant dosages. Clinical trials show low-dose CBD can cause significant liver enzyme elevations in 5.6% of healthy adults, necessitating liver function monitoring.

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The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.

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

Pharmacy Times

2 Guiding prescribers and patients through initiation of lumatperone, adjusting dosage amounts, and switching from other antipsychotics, emphasizing its favorable relapse reduction profile is key in preventing relapse.

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Real-World Data Shows Similar Clinical Outcomes in Patients Receiving Biosimilars Following Switch From Reference Product

Pharmacy Times

The most common reason for exclusion was the patient opting out of clinical follow-up with the specialty pharmacy team. Both Hadlima and Hyrimoz share the same strengths and dosages and have no clinically meaningful differences from Humira when relieving patient symptoms.