Sovaldi Aside, Declining Economic Returns On New Drugs Threaten Innovation – Study
Lifetime total costs exceeded expected revenues for novel products launched from 2005-2009, according to a paper published in Health Affairs. Focusing solely on recent successful launches like Gilead’s hepatitis C drug ignores the commercial fate of other once-promising drugs that turned out to be “dogs,” MIT researcher says.
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Gilead’s Sovaldi earned a spot in the record books – and the hearts of drug marketers – generating $8.55 billion in the first nine months of 2014. Despite controversy over Sovaldi’s high price, Gilead defended the drug’s value and executed flawlessly on the launch. Other 2014 drug launches were slow out of the gates, as the bar for new drugs continues to grow.
The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.
Discrete packaging for authorized dose in 6-11 year-olds is not yet available, so vaccination providers have to use product from a vial labeled for ‘booster doses only’ in adults. ACIP members unanimously endorse use of the mRNA vaccine in individuals ages 6-17 years but urge manufacturers to move away from relying on color to differentiate formulations.