Imagine you’ve hired a contractor to renovate your kitchen and a curtain is hung on the threshold, completely hindering your ability to see the project. You’re told that the curtain will be opened once a month so you may note progress. For the rest of each month, you’re left wondering whether any work is being done, if the project has hit snags, and if you approve of the project’s direction. I can think of few individuals who would stand for this type of arrangement and yet, until quite recently, that’s the way many CRO-sponsor relationships have functioned. (ghostwriting for ERT)
Orphan drugs often spell big profits for manufacturers, and unmet medical needs mean many camps are clamoring to quickly shuttle products to market.
Roche gears up to enter loaded hemophilia A drug ma...
A handful of anticipated branded products that gained FDA approval in the generics-dominated cardiovascular disease space have garnered barely audible post-launch applause. These treatments, both novel ones and me-toos, are being met with payer resistance, prescriber uncertainty, and pricing problems.
Despite their blockbuster status and distinction as the world's most widely prescribed class of drugs, statins may not be the best option for all patients with elevated low density lipoprotein (LDL) cholesterol levels.
The crop of late-stage biopharmaceutical agents angling for an FDA stamp of approval may find itself in one of the most challenging commercial climates in decades.
Companies must strike the right balance in data governance and reflect its importance through well-trained data stewards. (ghostwriting)