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France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after finding numerous GMP deficiencies. Read More
The European Medicines Agency has launched its PRIority MEdicines initiative to accelerate breakthrough therapies that offer a major therapeutic advantage over existing treatments. Read More
The Kentucky state Senate has passed a bill in a 36 to 1 vote that would permit interchangeable biosimilar substitution. The FDA has not yet approved an interchangeable biosimilar. Read More
Amgen is taking Novartis’s biosimilar division to court over alleged patent infringement for seeking FDA approval to produce a generic version of its blockbuster drug Enbrel. Read More