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WuXi STA breaks ground on new Delaware manufacturing facility

European Pharmaceutical Review

The second facility for WuXi STA in the US, Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labelling, storage and distribution services for clinical trial materials and commercial drug products.

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CTI wins over FDA to claim early review of myelofibrosis drug

pharmaphorum

Undeterred, CTI argued that it should move ahead with a filing based on additional data from an open-label study called PAC203, whilst also starting another phase 3 trial – PACIFICA – to bolster the data. Shortly after, Shire (now part of Takeda) ducked out of a $172 million partnership for the drug. Jakafi had sales of more than $1.1

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Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

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FDA Issues Long-Awaited QMSR Final Rule

The FDA Law Blog

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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