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Janssen’s third try to expand the indication for its anticoagulant Xarelto floundered Thursday when FDA advisors voted to recommend against its approval, citing concerns about the drug’s risks and missing clinical data. Read More
Health Canada issued guidance last month clarifying how the agency’s several centers will collect and manage information and material submitted by sponsors of prescription drugs. Read More
Merck’s blood thinner vorapaxar appears headed for the regulatory finish line after years of clinical hiccups, securing a 10-1 vote in favor of approval from an FDA advisory panel Wednesday. Read More
Chelsea Therapeutics’ second encounter with an FDA advisory panel over its blood pressure drug Northera has garnered an even stronger positive nod than a 2012 vote that resulted in a surprise complete response letter. Read More
Highlighting a growing dispute in the pharmaceutical industry, Johnson & Johnson is arguing that biosimilars should have international non-proprietary names (INN) that are similar to, but distinguishable from, reference products. Read More
Generic and brand drugmakers are urging the FDA to drop plans to require them to report manufacturing stoppages expected to result in shortages within five days of the stoppage occurring. Read More
With patents expiring on several blockbuster drugs in 2014, generic competition and cost-containment policies around the globe will hold brand pharma’s revenue growth at bay this year. Read More
Over the next five years, the FDA plans to release a host of guidances to implement the standardization of electronic drug applications and other regulatory submissions. Read More
While MiMedx disagrees with the FDA’s reasoning for requiring BLAs — and, hence, clinical trials — for its regenerative, human cellular and tissue-based products (HCT/Ps), the company says it will oblige the agency to set precedence for future products developed by competitors. Read More