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The European Medicines Agency has published a 100-page technical guide aimed at helping drugmakers comply with a new global standard on the reporting of individual case safety reports. Read More
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