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Integrating Early-Phase Development Clinical Supply Manufacturing Distribution

Integrating Early-Phase Development Clinical Supply Manufacturing Distribution
pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.

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Boost your HPV PCR assay design and development

In this article, LGC Biosearch showcases how it can help boost PCR assay design anddevelopment by leveraging its solutions. ....

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Integrating Early-Phase Development Clinical Supply Manufacturing Distribution

A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development,. ....

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Expediting Path To Clinic With OptiForm Total Supply

MGB Biopharma, a biotech company based in Scotland, U.K. was developing a new class of anti-infective medicine based on Minor Groove Binder compounds. ....

San Diego , United States , United Kingdom , Minor Groove Binder , Kansas City , Total Supply ,

MGB Biopharma - Successful End-of-Phase 2 Meeting with FDA for MGB-BP-3, a Potential New Gold Standard, First-Line Treatment for Clostridioides difficile Infection (CDI)

GLASGOW, Scotland, Jan. 27, 2021 /PRNewswire/ MGB Biopharma
, a biopharmaceutical company developing MGB-BP-3, a novel antibacterial, for the treatment of
Clostridioides difficile (CDI), today announces the successful completion of its End-of-Phase 2 (EOP2) meeting with the US Food and Drug Administration (FDA), an important milestone for the company and its lead product.
The EOP2 Meeting is a formal step at which companies seek confirmation that their product is considered safe to proceed to broader clinical studies, and to explore any additional studies that may be required before entering into Phase 3.
At the meeting, the US FDA confirmed that the design and the endpoints of our two prospective Phase 3 studies were appropriate. The Phase 3 studies, which are expected to recruit approximately 900 patients, will include superiority of MGB-BP-3 against vancomycin in the critical measure of sustained clinical response as one of their endpoints. ....

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