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Latest From Brenda Sandburg
Power Of Proprietary Drug Names To Be Studied By US FDA
FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.
Decade In Review: Biopharma's Shifting Legal Landscape
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.
US FDA's Decade In Review: From Biosimilars To Real-World Evidence
A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.
A Visual Guide To US FDA's Evolutionary Decade In Review
An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.
Supreme Court Takes Pass on Clarifying Patent Eligibility, Disappointing BioPharma
Industry now needs to wait for a more appealing appeal or a revived legislative effort after the high court declines review of Athena Diagnostics v. Mayo Collaborative Services, which created a sharp divide in the Federal Circuit, and Hikma v. Vanda; biopharma and others contend eligibility issue is biggest problem in patent system.
Individual Endpoints Pose Challenge For US FDA In Review Of Rare Disease Drug
FDA reviewer describes difficulties in reviewing application for Mepsevii for Sly syndrome; the experience provides perspective for other companies seeking to use novel endpoints.