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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

Since 2018, biotech company Mikrobiomik has been researching, development and producing innovative biological medicines based on the human microbiome. The specific representation of these events differed between the treatments, highlighting potential differences in side effect profiles that should be explored in further studies.

Safety 111
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Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

Pharmaceutical Technology

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. cases per 100,000 people in 2018. “In In the UK, the mean annual incidence of Lyme disease grew from 0.38

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Adherence to Treatment: Making the Most of the First 30 Days

PM360

The 2021 PURE report indicated that two out of three patients are concerned about potential side effects before taking their first dose, and again, this is more evident in women than men. Hospital Admissions Associated with Medication Non-Adherence: A Systematic Review of Prospective Observational Studies.” May 23, 2018.

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FDA proposes new model for easy-to-understand prescription guides

Pharmaceutical Technology

The document would include the drug/biological product name, side effects, directions for use, safety information, and a concise summary of indications and uses. According to a 2018 study , nonadherence is especially an issue in the case of chronic illness where patients may be expected to take medications at least once daily.

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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. rises/second (SD 0.0628) in the placebo group.

FDA 126
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Pharma Fix: The quest for the next tuberculosis vaccine

Pharmaceutical Technology

Fox says adjuvant protein subunit vaccines can be a safer approach compared to live attenuated virus vaccines as there is a minimized risk of developing side effects. Results from the Phase II trial were released for the vaccine in September 2018.

Pharma 64
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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% In the past, obesity medications were often dismissed due to insufficient efficacy data and the fact that they were associated with a high occurrence of side effects. The same can be said for the US. of adults were overweight, 42.4%

Medical 105