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Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More
Celldex Therapeutics has pulled the plug on a Phase 3 trial of immunotherapy Rintega in patients with EGFRvIII-positive glioblastoma after a mid-trial analysis showed the candidate fared worse than a control group. Read More
France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after finding numerous GMP deficiencies. Read More
The European Medicines Agency has launched its PRIority MEdicines initiative to accelerate breakthrough therapies that offer a major therapeutic advantage over existing treatments. Read More
The Kentucky state Senate has passed a bill in a 36 to 1 vote that would permit interchangeable biosimilar substitution. The FDA has not yet approved an interchangeable biosimilar. Read More