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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 2022, CMS reevaluated 505(b)(2) drugs in relation to section 1847A of the Social Security Act (SSA). This went into effect in January 2022.”

FDA
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Novartis’ Pluvicto presents survival benefit for castration-resistant prostate cancer

pharmaphorum

Pluvicto becomes the first PSMA-targeted intravenous radioligand therapy – combining a targeting compound or ligand with a therapeutic radionuclide or radioactive particle (in this case, lutetium-177) – to demonstrate clinical benefit in mCRPC patients before receiving taxane-based chemotherapy.

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Tuoyi to transform treatment of recurrent/metastatic nasopharyngeal carcinoma

Pharmaceutical Technology

Patients in the US and EU with recurrent or metastatic nasopharyngeal carcinoma (NPC), a subtype of head and neck squamous cell carcinoma (HNSCC), are mostly treated with a combination of chemotherapy agents in the frontline setting, such as cisplatin + gemcitabine. months for the chemotherapy arm (hazard ratio [HR]: 0.52).

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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy?

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EMA validates Enhertu® Type II variation application for lung cancer

European Pharmaceutical Review

This application is based on data from two Phase II trials: DESTINY-Lung02 Phase II trial presented at the European Society for Medical Oncology (ESMO) 2022 Congress. DESTINY-Lung01 Phase II trial published in The New England Journal of Medicine with updated data also presented at ESMO 2022. . DESTINY-Lung02 trial.

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OTC antiemetic medications: Relief for nausea and vomiting

The Checkup by Singlecare

Antiemetics may also reduce radiation-associated or chemotherapy-induced nausea resulting from cancer treatment. Be sure to follow the dosing instructions on the label for your child’s age. Antiemetic side effects Most OTC antiemetics are well-tolerated and safe if taken according to the labeled instructions.

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MHRA approves adagrasib for NSCLC after earlier EMA rejection

Hospital Pharmacy Europe

Adagrasib is a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation who have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.