Lack Of MS Clinical Guidelines Presents Challenge To Payers
Multiple sclerosis is one of the fastest growing areas of specialty drug spend.
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How To Withdraw A Drug: FDA’s Final Decision on Avastin
The “streamlined withdrawal” process for Avastin in metastatic breast cancer gave Genentech an extra 11 months to prepare for the transition to off-label status. It also gave FDA time to make preparations of its own.
Roche Pharma CEO Graham On Growth Prospects, Policy Pressures, Alzheimer’s And More
“I don’t think anybody can afford to not be in the Alzheimer’s race,” Graham said in one of her first public appearances since becoming CEO of Roche pharmaceuticals.
Commercial Fate Of Sarepta’s DMD Gene Therapy Remains Tied To EMBARK
The company guided investors to expect a narrow initial label under a US FDA accelerated approval for SRP-9001, with expansion possible based on EMBARK.