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The FDA could issue guidance on demonstrating interchangeability between a biosimilar and its reference product by the end of the first quarter of next year. Read More
A drug compounder not approved by the FDA says it is mixing pyrimethamine — the active ingredient in Daraprim — with another drug, folic acid-derivative leucovorin, at a cost of $99 per 100-count bottle to counter Turing Pharmaceuticals’ $750 per pill price on the blockbuster AIDS drug. Read More
Drugmakers facing a European GMP inspection should be prepared to provide complete documentation of active ingredients throughout the supply chain, going back to the starting materials that were used in the synthesis of the APIs. Read More
The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that drug bound to about half of the oral medications tested. Read More
The FDA has approved Merrimack Pharmaceuticals’ Onivyde, the first and only treatment for patients with advanced pancreatic cancer whose disease progressed after getting chemotherapy with gemcitabine. Read More
The FDA should establish searchable names and correct incomplete entries in its inactive ingredient database to enhance its accuracy and usability, generic drug and excipients makers say. Read More
Led by complaints about plaque psoriasis drugs, the FDA Adverse Event Reporting System recorded 205,389 primary suspect adverse event reports for 2,038 drugs in the second quarter of 2015, according to a new report by Advera Health Analytics. Read More