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Top Stories
In launching FDA's Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.
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The acquisition will place Cambrex into the finished dosage form CDMO market.
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Industry News
FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.
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Report predicts PAT, NIRS, continuous bioprocessing, and a 'technological arms race' could improve biopharma manufacturing efficiencies.
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Supplier News
The API and drug product provider will invest £375,000 (US$493,000) in additional nuclear magnetic resonance (NMR) instrumentation at its headquarters in Craigavon, UK.
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The glass and chemical provider will expand its synthetic pharmaceutical intermediate and API production capacity at its plant in Chiba, Japan.
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Bio/Pharma News
The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.
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The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.
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Early Bird Registration Available: Full Day E&L Symposium
Register for Eurofins Lancaster Laboratories' 2nd Annual Extractables & Leachables Symposium for Drugs and Devices on Thursday, September 20th in San Francisco, CA. Don't miss this opportunity to learn best practices, gain insight on regulations and hear case studies from Sanofi and Janssen.
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Regulatory News
Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.
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The agency has approved Tpoxx (tecovirimat), the first drug with an indication for the treatment of smallpox, to address the impact of a potential outbreak.
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Cleaning Validation:
As the industry's leading hands-on cleaning validation training, IVT's Cleaning Validation conference goes beyond best practices and solution oriented approaches; from bring your own challenge workshops and brainstorming think-tank discussions to solutions showcases and faculty "office hours" attendees are guaranteed to walk away with key actionable items for tackling the top challenges faced throughout critical cleaning process and validation lifecycles specific to their own environment.
 www.cbinet.com/cleaning |
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ANALYTICS
Traditional barriers between upstream and downstream bioprocessing are slowly starting to break down, as biopharma embraces more advanced analytics and process control.
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Data Integrity:
With FDA attention pinpointed on data integrity in recent 483s and warning letters, it is critical to arm yourself with the tools and resources to ensure data integrity in manufacturing processes. IVT's 4th Annual Data Integrity Validation provides a variety of industry perspectives in an unmatched training environment, diving deep into the nuances of building and maintaining a compliant data governance program across company-wide systems.  www.cbinet.com/dataintegrity |
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SUPPLY CHAIN
Vendors are offering template-based models and direct data-filing services to help smaller companies meet imminent deadlines.
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Events
August 6–10, 2018
August 13–14, 2018
August 15–16, 2018
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eBOOKS
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This ebook covers 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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