Rise and shine, everyone, another busy day is on the way. And we can tell because, already, the Pharmalot campus is buzzing. The official mascot is bounding about the grounds in search of creatures, and our shortest short person is readying plans for the day. As for us, we are busy with the usual tasks, namely firing up the coffee kettle to make cups of stimulation. Our choice today is Vermont maple walnut. As always, you are invited to join us. Meanwhile, here are a few tidbits to get you started. We hope you have a smashing day and conquer the world. And of course, do keep in touch. …
Provisions opposed by industry were dropped from a bill that makes it easier for the U.S. Food and Drug Administration to withdraw drugs that were approved under an accelerated timeline, according to STAT. Gone from the bill is a requirement that companies enroll clinical trials by the time of accelerated approvals. Lawmakers also stripped a requirement that product labels disclose that medicines have been approved using the accelerated approval pathway. The industry did lose a measure that would have explicitly stated that drug companies may use data from medical claims and insurance data to help confirm that drugs work in post-marketing studies.
Correction: An earlier version of this article incorrectly asserted that a provision about clinical trial enrollment timing had been stripped from the legislation.
The FDA lifted a partial clinical hold on studies for a Bluebird Bio gene therapy to treat sickle cell disease, Reuters writes. The decision ends a year-long halt on future studies and a pause in enrollment for ongoing studies of lovo-cel after one case of persistent anemia in a patient. The move also signals a more favorable regulatory environment for cell and gene therapies after a spate of clinical holds by the FDA in the last few years, according to SVB Securities analyst Mani Foroohar. Bluebird said its investigation showed patients with persistent anemia had a genetic trait called the alpha-thalassemia trait and would be excluded from future studies of the drug.
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