Top of the morning to you, and a fine one it is. Clear blue skies can be seen from our perch, the official mascot is happily bounding about the grounds, and our personal to-do list is actually looking a wee bit shorter today. So to celebrate, we are firing up the trusty coffee kettle for another cup of stimulation. Our fixation today is the aromatic cinnamon dolce. By all means, please feel free to join us. Meanwhile, we have assembled the latest list of interesting items for you to peruse. And we hope your journey is meaningful and productive. Best of luck and, as always, do stay in touch. We always appreciate your feedback. …
A dueling pair of federal court decisions has thrown the fate of the abortion pill mifepristone into jeopardy — and left regulators and drugmakers navigating uncharted territory, STAT notes. Meanwhile, hundreds of pharmaceutical and biotech executives argued that a ruling by a U.S. federal judge in Texas ignored both scientific and legal precedent and, if the ruling stood, it would create uncertainty for their industry. In an open letter, they called for a “reversal” of the court ruling that invalidated approval of the abortion pill and said they “stand together to unequivocally support the continued authority” of the U.S. Food and Drug Administration to regulate new medicines.
The FDA will hold an advisory committee meeting on June 9 to consider the bid by Eisai and Biogen to convert accelerated approval of their Alzheimer’s disease therapy Leqembi into a full approval – which could open the door to more widespread insurance coverage for the drug, Pharmaphorum writes. Leqembi was granted accelerated approval in January, with a fairly broad label to treat Alzheimer’s disease patients with mild cognitive impairment or mild dementia who have confirmed presence of amyloid pathology. The prospects for the drug will depend on how results are interpreted for a confirmatory trial.
About the Author Reprints
Create a display name to comment
This name will appear with your comment
