Novartis co-leads industry forum on preapproval access that aims to share best practices and engage patient groups; Janssen is launching three pilots to leverage collection of preapproval access data.

FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.

Emergence of the inter partes review process dramatically changed the patent dispute arena.  The decade also brought biosimilar litigation, generic price-fixing complaints, opioid lawsuits and new government investigations and antitrust actions.