SanBio, Inc. Receives $20 Million Grant From For Stroke Clinical Trial
Life Sciences Jobs ... Source: BioSpace
Why Theranos Could Burn Through All Its Cash by the End of This Year
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Sandoz Requests California Court Make Final Decision in Amgen Biosimilar Case
Following the U.S. Supreme Court’s defining decision on the biosimilar “patent dance” and approval process, Sandoz has requested that an unresolved part of its case against Amgen return to a…
FDA and EMA Collaborate on Expandable Model for Rare Pediatric Drug Development
The FDA and the European Medicines Agency released a draft joint plan Monday to support the development of pediatric treatments for Gaucher disease — an approach the agencies say can…
Supplement Company Warned on Unapproved Ingredients, GMPs
Three unapproved ingredients and a host of labeling and other GMP violations have resulted in an FDA warning letter for a Texas-based supplement company. Source: Drug Industry Daily
FDA Delays Enforcement of Supply Chain Identifier Requirements for One Year
The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Source: Drug Industry…
Strides Gets 483 for Quality Problems
Bangalore-based pharmaceutical company Strides Sashun, formerly known as Strides Arcolab, was recently cited by the FDA for quality problems with pills bound for U.S. markets. Source: Drug GMP Report
Quality Issues Lead to Shuttering of Teva’s Hungarian Plant
Teva is expected to close its facility outside Budapest, Hungary, following a string of quality control problems and major recalls. Source: Drug GMP Report
India Releases Draft SOP for Handling Out-of-Specification Drug Samples
The Indian government has developed new draft standard operating procedures for handling substandard drug samples. Source: Drug GMP Report
Indiana Compounders Indicted on Conspiracy, Drug Quality
The owner and compliance director of Pharmakon Pharmaceuticals routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results…
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