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Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
The FDA wants sponsors of investigational drugs and biologics to use the Logical Observation Identifiers Names and Codes to identify laboratory results from clinical studies in regulatory submissions, and is asking for suggestions on how it might assist firms in adopting the codes. Read More
Three years after introducing a trio of guidances explaining how sponsors must demonstrate biosimilarity to existing biological drugs, the FDA continues to stress the need for a “stepwise” approach when seeking approval. Read More
Tennessee has joined a growing list of 11 states to pass legislation enabling pharmacists to substitute a biosimilar for a branded biological product, in a move applauded by industry. Read More
A federal appeals court has granted a temporary injunction barring Sandoz from marketing its biosimilar of Amgen’s blockbuster chemotherapy drug Neupogen. Read More
An FDA advisory committee Tuesday voted 12 to 1 to recommend approval of the Vertex Pharmaceuticals Orkambi combination therapy for patients 12 years and older with two copies of the most common cystic fibrosis mutation. Read More
Reauthorization of the Prescription Drug User Fee Act is officially underway with the FDA’s announcement of a July 15 public meeting to assess the current PDUFA V. Read More
The National Pharmaceutical Pricing Authority says 59 of the top 100 companies have failed to register with the system, despite several deadline extensions. Read More
Sponsors seeking approval of new drugs based on published literature or postmarketing data must prove that their drug is comparable to its reference product. Read More