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The biopharmaceutical industry isn’t hiding its displeasure with a decision from the Centers for Medicare & Medicaid Services to treat all biosimilars based on the originator product as identical for billing and reimbursement purposes. Read More
President Barack Obama signed off on a budget bill Nov. 2 that will require generics makers to pay inflation-based rebates if prices rise too quickly, based on the inflation-adjusted baseline average manufacturer price. Read More
CMS issued a letter to four drug companies that produce or sponsor HCV treatments — AbbVie, Gilead, Johnson & Johnson and Merck — seeking answers as to why these drugs are so costly. Read More
The International Society for Pharmaceutical Engineering has launched a drug shortage assessment and prevention tool that helps drugmakers identify risks early on. Read More
Amgen has struck a deal with Harvard Pilgrim Health Care, through which it could pay rebates if its new cholesterol drug Repatha does not perform as well as it did in clinical trials. Read More
Days after signing a diabetes deal with Sanofi for $4.2 billion, South Korean Hanmi turned around to sign another diabetes deal with Janssen Pharmaceuticals. Read More
Since January, the FDA has issued 16 drug GMP warning letters covering 19 facilities, and more than three-fourths of those letters cited data integrity issues. Read More