KaloBios Announces New Transparency Measures for Drug Prices
Although it has no drugs on the market, KaloBios Pharmaceuticals has announced that it will limit price increases to the rate of inflation or Consumer Price Index, and will do…
AbbVie, Genentech Scoop Up FDA Approval for Leukemia Drug Venclexta
The FDA has given the green light to the chronic lymphocytic leukemia treatment Venclexta, which will be marketed by AbbVie and Roche’s Genentech unit. Source: Drug Industry Daily
Senate Committee Eyes Contempt Proceedings Against Valeant’s Pearson
Two lawmakers are mulling contempt proceedings against outgoing Valeant CEO J. Michael Pearson after he failed to provide a deposition on Friday as part of an investigation into drug pricing.…
FDA: Consider Real-World Usage Early On To Avoid Medication Errors
The FDA is pressing drugmakers to build risk assessments into their drug designs early on to cut down on medication errors. Source: Drug Industry Daily
WHO Letter Blasts Cadila on Data Integrity Concerns and GMP Issues
Shortly after receiving an FDA warning letter for alleged major quality deficiencies, an Indian vaccine maker was slammed for data integrity issues and GMP violations by the World Health Organization.…
FDA Bashes Two Indian Drugmakers for Allegedly Flouting Procedures
The FDA has slammed two Indian drugmakers — Emcure Pharmaceuticals and Lupin —for purported GMP violations. Source: Drug GMP Report
Quality Control Fears Prompt Letters to Four Dietary Supplement Makers
Four supplement makers were hit with FDA warning letters March 22 over alleged quality control violations and related issues. Source: Drug GMP Report
FDA Hits Compounders With Letters Over Sterility Issues, Misbranding
Two compounding operations are facing FDA allegations of producing adulterated drugs and doing so without prescriptions following agency inspections. Source: Drug GMP Report
Expert: Focus on Data Consistency to Streamline Quality, Compliance
The fragmented nature of the modern manufacturing sector necessitates focusing less on technology and more on integration, according to an industry expert. Source: Drug GMP Report
Contract Manufacturer Gets Letter Over GMP Concerns, Labeling Issues
A contract manufacturer is being hit with a warning letter over a slew of GMP and labeling violations. Source: Drug GMP Report
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