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Sanofi and Regeneron filed a complaint seeking a declaratory judgment that their eczema drug Dupixent, which is pending an FDA approval, does not infringe an Amgen patent on an unsuccessful asthma candidate. Read More
The Government and Accountability Office has agreed to grant a Senate request to conduct an investigation into the FDA’s handling of orphan drugs approvals. Read More
A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data integrity. Read More
The EMA’s Committee for Medicinal Products for Human Use recommended approvals for six drugs within the EU to treat a range of conditions from an endocrine disease to nausea. Read More
The UK’s antitrust regulator alleges that Actavis and Concordia entered a pay-for-delay agreement to block the market entry of generic versions of hydrocortisone tablets and fix prices. Read More
China’s Ministry of Human Resources and Social Security has expanded the list of drugs covered by state insurance, adding more than 300 drugs to the catalog since it was last updated in 2009. Read More
Regulations on off-label use are not harmonized across the European Union — only 10 out of 21 surveyed member states have specific policies, according to an European Commission report. Read More