We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
The European Medicines Agency and the European Commission today published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
The White House announced Monday that it plans to ask Congress for $1.8 billion in emergency funding to combat Zika, including $200 million to develop and commercialize vaccines and diagnostic tests. Read More
An update from Pfizer and Allergan on their proposed megamerger provides more insight into how Allergan product lines will be worked into Pfizer’s operating structure and various executive assignments. Read More
According to the letter, Monmouth’s IRB did not provide sufficient scrutiny to pediatric research, and conducted business without a quorum of members. Read More