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Sen. Charles Grassley (R-Iowa) is calling on the Justice Department to reconsider testifying before the House Judiciary Committee on its settlement with Mylan, which resolved allegations that the company overcharged Medicaid for its allergy therapy, the EpiPen. Read More
Nicox, an international ophthalmic R&D company, announced it received a complete response letter related to its NDA for its cetirizine eye drop formulation AC-170. Read More
The EMA Management Board has advanced the development of a web portal that will provide free information on European medicines across the products’ lifecycle. Read More
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More
The UK Court of Appeal affirmed an earlier ruling that invalidates Pfizer’s patent claims for Lyrica, saying generic versions will not lead to any infringement. Read More
Syntese has received a Form 483 after an inspection revealed sanitation, quality and laboratory control issues at the Denmark-based API maker. Read More
UK-based Wallace Cameron International has not fulfilled its registration obligations to continue manufacturing and exporting drugs to the United States, the FDA said. Read More