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Drugmakers should develop assays, tests and other processes to identify and mitigate any impurities in their products that may cause cancer, according to a European Medicines Agency guideline set to take effect January 2016. Read More
Canadian regulators plan to ratchet up scrutiny of patent litigation settlements between brand and generic drugmakers in search of antitrust deals that delay generic competition. Read More
A new bipartisan House bill would stop brandmakers from relying on a drug-control program to deny generics firms the batch samples they need to put together an ANDA. Read More
The FDA warned an active pharmaceutical ingredient manufacturer for not paying its facility user fees. However, the company says it hasn’t made APIs since 2008. Read More
Generics makers with first-to-file ANDA status say they are frustrated by the FDA’s slow approval times, claiming their 180-day market exclusivity period is jeopardized by agency inaction. Read More
Boston-based Epirus Biopharmaceuticals has received final approval in India for its biosimilar of the autoimmune therapy Remicade, making it the first biosimilar of the product in that country. Read More
The FDA for the first time has published a reference list for biologics, known as the Purple Book, that will list all brand products and any biosimilars with which they are interchangeable. Read More
The FDA’s database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, say generics makers who laid out a variety of other shortfalls they see in the agency’s generic drug approval process. Read More
The FDA needs to clarify whether its 10-day ANDA correspondence clock starts ticking once a manufacturer receives the agency’s communication or at the moment the agency mails it, say generics firms, which also urge the FDA to start sending all communications by fax or email. Read More
European regulators have approved Eli Lilly and Boehringer Ingelheim’s insulin glargine drug Abasria, a biosimilar version of Sanofi’s blockbuster product Lantus. Read More
The FDA is moving to ease industry fears that ANDAs filed after September of this year will receive priority over earlier applications simply because they were filed before the law required the agency to assign review deadlines to new applications. Read More