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

Pharmacy Times

This act…allowed a pathway for manufacturers to create a ‘copy’ of a licensed patent product to make it cheaper and more discounted,” Soefje, director of pharmacy cancer care services and associate professor of pharmacy at Mayo Clinic in Rochester, Minnesota, said at the HOPA conference. However, the FDA allows this process.”

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Immunotherapy Takes the Lead in Advanced Cutaneous Malignancies

Pharmacy Times

Blood cancer patients are usually at higher risk due to prior chemotherapy, and maybe we don’t need the same kind of prophylactic medications for solid tumor patients. I think we’re getting to the point now where hematology and oncology both need services that can manage these types of side effects. The infection risks are a little different.

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Pharmacists Take the Lead on Advanced Therapeutics

Pharmacy Times

Tichy, PharmD, MBA, vice chair of pharmacy formulary for Mayo Clinic, explained. Dalton shared her surprise about how variability in manufacturing affects the patient experience, given that some products created using the patient’s cells may not always be usable or up to FDA standards. REFERENCES 1. Updated March 20, 2023.

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TRE-5151 Receives FDA Fast Track Designation in Combination With Radiation Therapy for Prostate Cancer

Pharmacy Times

SHOW MORE FDA fast-tracks TRE-515 for advanced prostate cancer, combining it with radiation therapy to enhance treatment outcomes and patient care. The FDA has granted fast track designation to TRE-515 (Trethera Corporation), a novel drug, in combination with radiation therapy for the treatment of prostate cancer.

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Navigating EGFR Mutations and ALK Fusions in Early-Stage Non-Small Cell Lung Cancer

Pharmacy Times

1 Biomarker testing is relatively new in the treatment landscape for NSCLC but has proven incredibly important for personalizing patient care, transforming from a generic chemotherapy approach to a highly personalized, genomically driven treatment strategy. For advanced disease, chemotherapy was the standard.

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CoQ10 side effects and how to avoid them

The Checkup by Singlecare

Safety measures while using CoQ10 What are the FDA warnings about CoQ10? The Food and Drug Administration (FDA) has not issued any warnings about CoQ10. It is available over the counter, so the FDA has determined that it’s safe to use without medical supervision. Who should never take CoQ10? Who should use caution with CoQ10?

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ASH roundup: late breakers take the stage

pharmaphorum

At ASH, the E1910 clinical trial generated results could unlock a new patient population for Blincyto, after it was shown to improve overall survival in patients with no measurable residual disease (MRD) after induction chemotherapy for B-ALL. At the moment, Blincyto is approved to treat patients with MRD after induction treatment.