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.
Drugmakers and industry groups are urging regulators in Australia to abandon proposed new requirements that call for larger type on drug labels and that labels be made and applied so that they cannot be damaged by opening a product. Read More
Astellas Pharma has settled a class action lawsuit that accuses the brandmaker of filing a frivolous citizen petition and subsequent lawsuit solely to delay generic competition to its transplant drug Prograf. Read More
Baxter plans to roll out two of its Phoxillum solutions for continuous renal replacement therapy in the second quarter of this year, following FDA approval earlier this month. Read More
An FDA advisory committee may have given its unanimous approval for a biosimilar application this month, but industry and patient groups contend the regulatory pathway still has many potholes and unanswered questions. Read More
The FDA will maintain its policy on determining when an orphan drug product is entitled to market exclusivity, saying a recent federal court ruling that overruled the agency’s policy applied to just one drug and established no precedent. Read More
Unauthorized knock-offs of Gilead’s pricey blockbuster hepatitis C therapy, Sovaldi, may soon hit the market in India after the government refused to grant it patent protection. Read More
Mylan and Abbott have submitted proposed commitments to the European Commission’s competition oversight body to allay anti-competitive concerns over a proposed merger that would reincorporate Mylan in the Netherlands. Read More
Actavis must keep its Alzheimer’s drug Namenda on the market for now, but a recent agreement with the New York Attorney General will let the company avoid notifying more than half a million people of that fact. Read More