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Teva is paying $40.5 billion to acquire drugmaker Allergan’s generic division, walking away from efforts to purchase Mylan for a similar amount. Read More
The European Commission is suspending sales and distribution of 700 formulations of more than four dozen generic drugs after determining that the bioequivalence testing on which their approvals were based included manipulated echocardiogram data. Read More
Takeda’s diabetes drug Actos, which has caused the company to pay nearly $2.4 billion to settle lawsuits over cancer risks, did not increase the risk of bladder cancer in a large postmarketing study, the drugmaker says. Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the FDA, saying draft guidance lacks clear criteria and examples. Read More