Against a backdrop of expanding FDA approvals for opioids, several senators are going over the agency's head to enlist support to fight the accompanying opioid addiction problems.
Slapping back at Allergan plc, a venture capital fund is defending its right to try to invalidate the drugmaker's remaining patent on a glaucoma drug by taking advantage of the lower "patent-killing" standard of an inter partes review (IPR) before the Patent Trial and Appeals Board (PTAB).
As a trail-blazing pioneer in biologics, Amgen Inc. has the unenviable position of having to mark the patent protection path against biosimilars targeting its legacy products.
A federal district judge shot down the FDA's attempts to marginalize the Second Circuit's Caronia ruling in justifying its continued censorship of drugmakers' truthful comments about off-label uses of their products.
Faced with more than 80 million genetic variants that may or may not affect a person's health or risk of disease, the FDA is realizing that it will take a village in the cloud to expand its current regulatory borders and deliver the promise of precision medicine.
Providing guidance on how to avoid obviousness for next-generation products and what it considers an adequate written description in patent claims, the Federal Circuit upheld several patents relating to a safer, revised formulation of Allergan plc's glaucoma drug Lumigan.
As technology pulls medical innovation into the 21st century, the burnish may be wearing off randomized, controlled trials (RCTs), the FDA's longtime gold standard for developing new therapies.