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Top Stories
The transaction is set to be completed in the first quarter of 2020.
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The transaction is anticipated to close by the end of 2019.
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PYRAMID Laboratories, Inc. is a CMO focused on injectables, established in 1988 in Southern California, we offer aseptic vial and syringe filling, as well as lyophilization, for both Clinical and Commercial products. Our laboratory offers development and analytical capabilities in a cGMP/GLP setting. For 30 years, we have provided clients with Top Quality services assuring that their critically important parenteral products reach patients in need.
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Industry News
The company is recalling Alprazolam Tablets, USP C-IV 0.5 mg because of potential presence of foreign substance.
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The goal of the investment is for the cures to be made available across the globe, including in sub-Saharan Africa’s low-resource communities.
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Supplier News
Gerresheimer enlarged a cleanroom, installed a high-performance furnace, and automated testing and packaging systems for pharmaceutical glass packaging in Essen, Germany.
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GE Healthcare Life Sciences’ KUBio box is an integrated, flexible biomanufacturing environment for viral vector-based gene therapies.
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Bio/Pharma News
The therapy received positive results in a randomized, double-blind, placebo-controlled clinical trial in 34 adults with proven celiac disease.
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CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.
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Regulatory News
The agency’s implementation of the SUPPORT Act has included new guidance documents and actions to restrict illicit drugs entering the US.
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CHMP has recommended that Baqsimi (glucagon), a non-injectable treatment for severe hypoglycemia, be granted marketing authorization in the EU.
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ANALYTICS
Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution.
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QUALITY SYSTEMS
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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Explore Transparency with the Emprove® Program
With the Emprove® Program, full supplier transparency is available at your fingertips. Access regulatory information online through our Emprove® Suite. Find comprehensive regulatory documentation for filters, single-use components and raw and starting materials to simplify your qualification, risk assessment, and process optimization.
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FORMULATION
A complete understanding of primary packaging physicochemical properties is necessary in the formulation and development of biologics.
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REGULATORY WATCH
A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.
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UPCOMING WEBCASTS
An Integrated Approach to Spray Drying: From Scale-Up to Manufacturing
November 19, 2019 at 11am EST | 8am PST | 4pm GMT | 5pm CET
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The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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