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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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STAT+: Pharmalittle: Weight-loss drug ads pose new oversight challenge; will the new Bayer CEO split the company?

STAT

They may involve infusions of a gene packaged inside the shell of a virus, which can lead to potential immune complications and can require close monitoring of patients. Promising therapies for some diseases are administered through lumbar punctures, which are not a routine part of a doctor’s daily practice.

Packaging 191
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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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European Pharmaceutical Review Issue 4 2023

European Pharmaceutical Review

Included in Issue 4 of European Pharmaceutical Review : FOREWORD Dissolution testing – a dual role David Elder, David P Elder Consultancy REGULATORY INSIGHT EU packaging reform: a prescription for change?

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iOnctura and Clavius exercise option for TGF-? pathway inhibitor

Pharmaceutical Technology

It will help the firm target therapy resistance and immune evasion pathways, along with IOA-359’s direct impact on the tumour. The grant will see the use of UT’s model system to help iOnctura with a preclinical pharmacology package for IOA-359 in cancer. iOnctura will exclusively develop and commercialise IOA-359 across the globe.

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Emergent BioSolutions announces approval from FDA for CYFENDUS vaccine

Pharmaceutical Business Review

It is shown that by using a further adjuvant, two doses administered over 14 days demonstrate protective levels of immune response, and this can be particularly significant in response to a public health emergency involving anthrax. In 2019, the US government commenced procuring this product for national preparedness efforts.