Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
|Articles|April 19, 2012
Industry Briefs: Apr. 16, 2012
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.
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Company News
AMRI and Biota have agreed to develop and manufacture the influenza antiviral CS8958 (laninamivir), a second-generation, long-acting neuraminidase inhibitor.
Evans Analytical Group (EAG) has acquired PTRL West and PTRL Europe.
Nascent and Catalent Pharma Solutions have formed a product-development agreement for a Nascent antibody drug candidate.
Pharmatek has added to its liquid encapsulation capabilities.
Q Laboratories has completed construction on its 5000-ft2 microbiology research and development laboratory.
Shire has agreed to acquire Pervasis Therapeutics and related endothelial cell technology.
Vanda Pharmaceuticals has acquired the rights to an NK-1 receptor antagonist from Eli Lilly.
People News
Hospira has named John B. Elliot senior vice-president of operations.
Penn Pharma has appointed Jerome Detreille as senior director of new business development.
Michael A. Griffith has been appointed to Repligen’s board of directors.
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This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
Florin Muraru, Gourav Pandey, and Richard Jaenisch explain where human sign-off belongs as multi-agent AI and document-parsing models reach GxP.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
The EC has approved AstraZeneca's Trixeo Aerosphere as the first single-inhaler triple-combination therapy for asthma in the EU, based on phase e data showing improved lung function and fewer severe exacerbations in patients uncontrolled on standard ICS/LABA treatment.
In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.
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