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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. The regulator allows biosimilars to show slight differences in clinically inactive components of a product. What is a Biosimilar?

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Diamyd Medical and Critical Path Institute announce data sharing collaboration to develop advanced drug development tools in type 1 diabetes

The Pharma Data

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. People with type 1 diabetes cannot produce insulin.

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1 Hour Belly Blast Diet

The Pharma Data

The insulin-like effect of muscle contraction. Exercise and insulin sensitivity: a review. AMPK and Exercise: Glucose Uptake and Insulin Sensitivity. The insulin-like effect of muscle contraction. Exercise and insulin sensitivity: a review. AMPK and Exercise: Glucose Uptake and Insulin Sensitivity.

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WHO establishes global biomanufacturing training hub in Republic of Korea

The Pharma Data

The World Health Organization (WHO), the Republic of Korea and the WHO Academy today announced the establishment of a global biomanufacturing training hub that will serve all low- and middle-income countries wishing to produce biologicals, such as vaccines, insulin, monoclonal antibodies and cancer treatments.

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Scottish drug discovery: advancing new research models

Drug Discovery World

The aim of the researchers is to understand the mechanisms that regulate cancer cell proliferation, survival and dissemination; to identify critical components of these pathways as targets for novel cancer therapies; and to help translate this knowledge to patient benefit.

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Nine for 2023, part three: thriving or surviving?

pharmaphorum

Heating, ventilation, and air conditioning (HVAC) systems for validated cleanroom areas of a plant, for example, are essential and subject to stringent regulation, and consume many times more energy than non-validated areas. Medicines distribution and supply is also an energy intensive and regulated business.

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Pharma still reluctant to back gamification for health; interview

pharmaphorum

Sri Prakash describes FriendsLearn’s approach as administering a “digital vaccine” that along with changing habits could induce an immune response through biological pathways of the gut-brain axis – a two-way communication channel linking emotional and cognitive centres of the brain with peripheral intestinal functions.