Commercial Operations

Janssen Sues Samsung Bioepis to Block Remicade Biosimilar

Janssen has filed suit in a New Jersey federal court, hoping to delay a recently approved Remicade biosimilar from entering the market — while the biosimilar’s developer, Samsung Bioepis, bets on an upcoming Supreme Court decision going its way. Read More

Cures Act Left Drug-Device Distinction Murky, Panel Says

The 21st Century Cures Act represents a “missed opportunity” to clarify the distinction between a drug and a device and improve transparency, according to experts at a June 8 conference sponsored by FDAnews in Washington D.C. Thursday on combination products. Read More