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Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More
With BioMarin’s Duchenne muscular dystrophy candidate drisapersen failing to garner FDA approval this week, a competitor close on its heels also is facing questions from the agency over whether it offers any benefit. Read More
The U.S. Patent and Trademark Office dealt Amgen a blow in its bid to market a biosimilar version of AbbVie’s Humira, refusing to block existing patents for the blockbuster rheumatoid arthritis treatment. Read More
Prizing collaboration and reduced burdens on drugmakers, the European Medicines Agency hopes to bolster a stronger drug development process in the coming years. Read More
The FDA is recommending that drugmakers create safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded. Read More
The FDA has delayed BioMarin’s plans to market drisapersen, the company’s Duchenne muscular dystrophy candidate, with a complete response letter calling for more evidence of the therapy’s benefits. Read More
With an eye toward patient-focused drug development, the FDA is seeking feedback on a compilation of diseases and outcome measures gathered together under a new pilot program. Read More
Robert Califf, President Barack Obama’s choice to head the FDA, is calling for clinical trial reform, but does not believe new regulations are needed. Read More
Good data integrity practices are drawing attention on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices. Read More