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Shire is taking a second shot at the FDA for its eye treatment lifitegrast, resubmitting an NDA months after the agency said it needed more information before it could approve the candidate. Read More
Illegal conduct in the compounding and dietary supplement industries are two of the U.S. Department of Justice’s top three areas of increased focus, a deputy assistant attorney general said Dec. 9, 2015. Read More
The FDA has updated its list of scheduled guidances for the calendar year 2016, with a major focus on pharmaceutical quality, data integrity and generics. There are 102 planned guidances this year, compared with 92 last year. Read More
CDER Director Janet Woodcock sees PDUFA reauthorization and beefing up staffing as two top priorities that will occupy much of the FDA’s time over the next year. Read More
Roche says it is cooperating with inquiries from the Indian states of Gujarat and Telangana, where sales of its cancer drug Avastin were halted after 15 patients experienced pain and swelling in their eyes. Read More
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