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New Zealand signing off on the Trans-Pacific Partnership on Feb. 3 should start the clock ticking for ratification of the treaty, which provides up to eight years of exclusivity for biologics. 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
The UK’s National Institute for Health and Care Excellence has issued recommendations for NHS to reimburse the use of seven biologicals in treating severe rheumatoid arthritis, along with four new cancer treatments and a lung disease therapy. Read More
The FDA repeatedly blasted overseas drugmakers last year for disregarding compliance orders and not living up to their own promises to carry out proper cGMP practices for active pharmaceutical ingredients. Read More
In a rare warning letter to an institutional review board, CDER’s Office of Scientific Investigations contends that an IRB at Monmouth Medical Center was lax in supervising research at the facility. Read More
The FDA plans to establish a system that would allow for the use of “real-world evidence” to help the agency more quickly identify safety signals and address concerns, according to its list of strategic priorities for 2016-2017. Read More
With 12 nations signing off on the Trans-Pacific Partnership on Wednesday, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Read More
An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support Tuesday, backing its approval for six different indications in a 21-3 vote. Read More
Republicans on the Hill already are blasting the White House’s fiscal year 2017 budget, which would give the FDA about $5.1 billion, roughly $358 million more than what the agency received last year. Read More