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Latest From Laura Helbling
US FDA seeking input on proposed approach to allow device sponsors to seek marketing authorization for a device labeled for use with a drug – even if the drug sponsor does not want to cooperate on the new use.
US FDA has updated the label for Purdue’s opioid pain therapy Butrans to note the existence of a pediatric study for the buprenorphine formulation. After consulting with its advisory committee, FDA didn’t include any further information.
Amgen’s argument that continuing the Medicare new technology add-on payment for Blincyto would allow for more data to be collected failed to persuade US CMS.
As the amount of data increases, artificial or augmented intelligence is becoming an increasingly important tool for drug development. More pharma and biotech companies may need to get on board.
Supercomputing could mean major progress for pharma – particularly when the machine can predict interventions.
The first gene therapy approval could be coming soon – followed shortly by the first ever gene therapy coverage decision. An Express Scripts executive argues that the tone may be affected by the initial indication.