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

Pharmacy Times

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling.

FDA 65
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Unicorns Don’t Exist: Rethinking the Generalist Model in Oncology Pharmacy

Pharmacy Times

There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. Touchstone Books; 2013. Oncology pharmacy practice changes at a rapid pace. Time Enough for Love. Putnam’s Sons; 1973.

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AZ eyes FDA verdict on Lynparza in adjuvant breast cancer in Q1

pharmaphorum

AZ and partner Merck & Co have filed Lynparza (olaparib) for use in BRCA-mutated, HER2-negative early breast cancer in patients who have already been treated with chemotherapy either before or after surgery and are at high risk of the disease coming back. billion in sales for AZ last year, while Merck booked $725 million from the drug.

FDA 111
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AZ, Merck get FDA okay for Lynparza as adjuvant breast cancer therapy

pharmaphorum

The new approval is for use in patients with BRCA-mutated, HER2-negative early-stage breast cancer who have already been treated with chemotherapy – either before or after surgery – and are at high risk of the disease coming back. billion in sales for AZ last year, a rise of around 25%, while Merck booked just under $1 billion from the drug.

FDA 140
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ASCO21: Lynparza aces adjuvant breast cancer therapy trial

pharmaphorum

Giving Lynparza (olaparib) to women with BRCA-positive, HER2-negative breast cancer straight after chemotherapy and surgery to remove the tumour reduced the risk of recurrence, secondary cancers or death by 42% compared to placebo after 2.5 billion in sales for AZ last year, with Merck booking $725 million in alliance revenues.

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Selenium: The Nutrient That Can Reduce Thyroid Antibodies by 40%

The Thyroid Pharmacist

It’s important to note that selenium may also interact with other supplements and medications, such as cholesterol-lowering statin drugs, antacids, chemotherapy drugs, corticosteroids, niacin, and even birth control pills. You can find out more about iodine in the Advanced Protocols section of my book Hashimoto’s Protocol.

Dosage 59
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How to Lose Weight With Hashimoto’s

The Thyroid Pharmacist

I outline a plan including these strategies and many others in my book, Adrenal Transformation Protocol , which is based on my wildly popular Adrenal Transformation Program. 14] My Adrenal Transformation Program and book were designed to support mitochondrial health. Amino acids can also be helpful for exercise recovery.