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Considerations for a Decentralized Manufacturing Paradigm

ISPE

www.fda.gov/media/162157/download 7 Okwudire, C. Nature Communications 12, no. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/examples-accepted-emerging-technologies 26 Eisner, D. Discussion paper. October 2022. Madhyastha.

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Covid-19 vaccine success bolsters nanoparticle drug delivery research

Pharmaceutical Technology

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995. Please check your email to download the Report.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Results from this trial are scheduled to be released in October 2027, and may allow non-diabetic obese patients to have access to Mounjaro. Please check your email to download the Report.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Results from this trial are scheduled to be released in October 2027, and may allow non-diabetic obese patients to have access to Mounjaro. Please check your email to download the Report.

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Pliant snags $287.5 million in oversubscribed public offering amid market uncertainty

Pharmaceutical Technology

The FDA approved both drugs in 2014. On February 2, the FDA cleared an Investigational New Drug Application for PLN-101095. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector.

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