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

Pharmacy Times

Although no formal contraindications are listed in AstraZeneca’s US labeling, perioperative management may require holding acalabrutinib 3 to 7 days before and after surgery to minimize bleeding risk. Hepatotoxicity and drug-induced liver injury are additional risks that require monitoring.

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Nemolizumab Shows Rapid, Sustained Efficacy in Atopic Dermatitis

Pharmacy Times

The findings emphasize nemolizumab’s swift response in treating atopic dermatitis symptoms, along with its long-term effectiveness in prurigo nodularis, as demonstrated in the OLYMPIA open-label extension trial (NCT04204616).

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FDA Removes REMS for Currently Approved BCMA-, CD19-Directed CAR T Cell Immunotherapies

Pharmacy Times

Accurate product labeling and ongoing safety monitoring remain essential for patient safety in CAR T therapies. Still, providing accurate product labeling for these products—which properly conveys the risks of CRS and neurological toxicities—remains essential to ensuring patient safety.

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Once-Daily Alixorexton Improves Wakefulness at All Doses in Patients With Narcolepsy Type 1

Pharmacy Times

In a sign of alixorexton’s tolerability, over 95% of patients who participated in this portion of the trial elected to join the ongoing 7-week, open-label extension.

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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

If approved, lumatperone’s expanded label could offer health care teams a valuable tool to improve stability, well-being, and real-world outcomes for patients with schizophrenia. 1-3 REFERENCES 1. Johnson & Johnson.

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Pharmacists Have a Crucial Role Helping Patients With ATTR-CM Navigate Treatment With Tafamidis

Pharmacy Times

Additionally, tafamidis stands out compared with other TTR stabilizers that are used off-label and require monitoring for renal and gastrointestinal AEs. Additionally, pharmacists are also vital in identifying financial assistance programs or navigating specialty pharmacies or mail-order services.