Upcoming changes in the Medicare Part D benefit that involve increasing the risk borne by insurers in the catastrophic phase may boost pressure on plans to control costs in the six protected classes and manufacturers are worried about what that might lead to.
Medicare Part D Redesign Will Sharpen Policy Focus On Protected Classes
Manufacturers worry that the redesign will prompt tighter controls in the protected classes, while some research indicates plans are already using all the tools at their disposal to manage some key classes, such as cancer drugs, suggesting they may need to be able to do more.

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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth