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FDA declines Eli Lilly’s bowel disease drug over manufacturing issues

Pharmafile

However, concerns weren’t expressed over the clinical data package, safety or label for the medicine. Mirikizumab was hoped to become a new drug treatment for ulcerative colitis (UC), a condition where abnormal reactions in the immune system cause inflammation in the inner lining of the colon. read more

Packaging 119
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What Are Biopharmaceuticals?

Pharma Packaging Solutions

Whole blood, organ and tissue transplants, breast milk, antibodies for passive immunity, fecal microbiota, human reproductive cells, and stem-cell therapy are all examples of this type of biologic. As biopharma technology progresses, becoming both more prevalent and available, the need for high-quality biopharma packaging increases.

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Mitigating fill, finish and CCI challenges for injectables

Express Pharma

In the case of parenteral drugs, CCI aims to avoid adulteration of the drugs packaged in vials, syringes, and cartridges. Even though these types of packaging systems are sealed in a hermetic manner, there are still many risks to mitigate. Vials, cartridges, and syringes are often packaged one of two ways. micron filter.

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Pharmacist Guide to Managing Fever

FADIC

Fevers may also transpire after the administration of common childhood immunizations. Because antipyretics can also be found in many allergy, cold, cough, and flu products, patients should be advised to always read all medication labels prior to administration to avoid therapeutic duplications or possible medication overdose.

Immunity 103
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September 2023 Newsletter

Safe Biologics

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. The product is an interleukin-6 (IL-6) receptor antagonist that targets specific inflammatory proteins to suppress the immune system. However, S.6 ASBM surveys of U.S.

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Eric Halioua, President & CEO at PDC*line Pharma Shares Insights on the Results from P-I/II Trial with PDC*lung01

PharmaShots

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC). 2015; Zhu et al., 2015; Zhu et al.,

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Pharmacologic Management of Crotalid Envenomation

Pharmacy Friday Pearls

Crotalidae Polyvalent Immune FAB (Ovine). Crofab ® [package insert]. Crotalidae Immune F(ab’)2 (Equine). Anavip ® [package insert]. Patients can develop delayed or recurrent hematologic symptoms up to a week after treatment cessation, especially following a severe envenomation. Pharmacology. 2020;77(3):175-187.