Jun 10 2021
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Since the groundbreaking Barr Labs case in 1993, the FDA has issued hundreds of observations concerning poor handling of out-of-specification (OOS) investigations, necessitating untold hours of lab effort as well as significant fines. Today, gravimetric sample preparation is giving pharmaceutical companies around the world a cost-effective way to avoid OOS errors, which in turn is helping them to reduce the occurrence of time-wasting investigations, enhance productivity and safety, and save costs.
From the number of warning letters issued periodically by the US Food and Drug Administration (FDA), it is apparent that OOS results are more common in pharmaceutical manufacturing than they should be. These errors not only result in time-consuming internal investigations and fines. Depending on an error’s extent and market visibility, it can also make a significant impact on a pharmaceutical company’s reputation and profitabi
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Crystal Bridge Enterprises Inc.: Crystal Bridge Provides Transaction Update
Company ) is pleased to provide an update regarding its Qualifying Transaction (the
Transaction ) with Alpha Cognition Inc. (
ACI ), as previously announced on July 14, October 28 and December 4, 2020. The Company is pleased to announce that ACI has obtained an interim order of the Supreme Court of British Columbia providing for, among other things, the holding of ACI s special meeting of shareholders and warrant holders to approve the Transaction, which is scheduled for March 10, 2021. The hearing to obtain the final order of the Supreme Court of British Columbia is scheduled for March 15, 2021, with closing of the Transaction anticipated later in March 2021.