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Teva will pay $519 million — the largest fine levied against a drugmaker for violating a foreign corruption law — to resolve international bribery charges involving business operations in the Ukraine, Russia and Mexico. Read More
Teva alleges six generics makers infringed a patent covering its multiple sclerosis therapy Copaxone when seeking approvals for copycat versions of the drug. Read More
The FDA has rejected Advanced Accelerator Applications’ candidate for the treatment neuroendocrine tumors in adults, requesting that the company submit new analyses and correct manufacturing deficiencies. Read More
The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry. Read More