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Amgen is acquiring Dutch biotechnology company Dezima Pharma for $300 million plus up to $1.25 billion in milestone payments, the companies announced Wednesday. Read More
Amneal Pharmaceuticals can begin marketing its generics version of Allergan’s Alzheimer’s extended-release drug Namenda XR on Jan. 31, 2020, pending FDA approval, under an agreement reached by the two firms. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif. manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More
Concordia Healthcare is acquiring UK-based Amdipharm Mercury for $3.5 billion, in a deal that greatly expands the Canadian drugmaker’s generic portfolio and global reach. Read More
With the last legal hurdle removed, Sandoz wasted no time launching its Zarxio biosimilar of Amgen’s chemotherapy product Neupogen nationwide — offering the first U.S. biosimilar at 15 percent below the price of its reference product. Read More
The FDA has banned imports of drugs made at Mumbai-India based Polydrug Laboratories, marking the latest development in ongoing issues involving Indian manufacturers. Read More
The GPhA is challenging the legality of the FDA’s final guidance calling for generics makers to design tablets and capsules to be similar in size and shape to their reference drug to ensure patient acceptance. Read More