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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. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.

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

Pharmacy Times

But together, they contribute to the ever-expanding expectation that oncology pharmacists should “know all the things,” an emotion aptly captured by Allie Brosh in her book Hyperbole and a Half. Touchstone Books; 2013. Time Enough for Love. Putnam’s Sons; 1973. Rao KV, Gulbis AM, Mahmoudjafari Z.

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Investigating the Pharmacist’s Role in Psychedelic-Assisted Psychotherapy for Patients With Cancer

Pharmacy Times

In the 2017 book The Big Picture , author Sean Carroll seamlessly blends the scientific with the philosophical and comments that “life is not a substance, like water or rock; it’s a process, like fire or a wave crashing on the shore. Fortunately, he had a great oncology team with a pharmacist who specialized in gastrointestinal oncology.

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Disappointment as Lynparza fails colorectal cancer test

pharmaphorum

They were randomised to either Lynparza alone, Lynparza plus Avastin or chemotherapy plus Avastin, a standard treatment in this setting. billion for AZ last year across its eight FDA-approved indications, while Merck booked $989 million from its share of profits from the drug.

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Uncovering the potential of ADCs to target tumours

European Pharmaceutical Review

1,2 This is especially important in forms of cancer where chemotherapy remains the main treatment option. Because ADCs offer a good way to specifically deliver an effective treatment to tumour systems, this could be an improvement on the systemic impact of chemotherapy. ASCO Educational Book. References Fu et al.

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Solutions for Constipation Relief

The Thyroid Pharmacist

Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. [45] As the intestines are made of smooth muscles, a reduction in the action of these muscles can slow down digestion and cause constipation. 2020;12(1):205.

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

pharmaphorum

The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over pretenders to its PARP inhibitor crown. billion in sales for AZ last year, a rise of around 25%, while Merck booked just under $1 billion from the drug.

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