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Danish insulin maker Novo Nordisk is expanding its footprint in the U.S., acquiring two privately held biopharmaceutical research companies in Indiana and investing in a new manufacturing plant in North Carolina. Read More
Mylan continues to breathe down Perrigo’s neck, announcing that two-thirds of votes cast during Friday’s shareholders meeting support the hostile takeover of the Dublin-based company. Read More
Last month, the FDA zapped seven more compounders in Tennessee, California, Florida, Arkansas, Montana and Washington over sterility issues. The FDA handed out three warning letters, three Form 483s and one facility issued a recall following an inspection. Read More
The FDA approved Amgen’s Repatha late Thursday for some patients who are not able to control low-density lipoprotein cholesterol using standard treatment options, making it the second PCSK9 inhibitor to receive the agency’s blessing. Read More
A federal judge Wednesday said AbbVie and Teva can continue an arrangement that delays the launch of generic versions of the testosterone drug Androgel — rejecting the FTC’s request that he reconsider his earlier decision that the agreement was not pay-for-delay. Read More
The FDA handed Baxter Healthcare a six-observation FDA Form 483 for lapses in sterile process controls and failure to review batch discrepancies at its Puerto Rico manufacturing plant. The drugmaker has been plagued in recent months over recalls of sterile IV solutions. Read More