Good morning, everyone, and how are you today? We are just fine, thank you. Although gray skies are enveloping the Pharmalot campus, our spirits remain sunny. After all, as the Morning Mayor taught us: “Every new day should be unwrapped like a precious gift.” So go ahead and tug on the ribbon. While you do, we will indulge with another cup of needed stimulation. Our choice today is maple bourbon. Meanwhile, here are some items of interest. Hope your day goes well …
In a move that seemed out of reach just six months ago, the Food and Drug Administration approved Moderna’s influenza vaccine for older adults, the first licensed flu shot made using messenger RNA technology, STAT says. In February, Vinay Prasad, the FDA’s head of biologics at the time, overturned the recommendation of career staff and issued a rare “refusal to file” notice” to the company, saying the agency would not review the vaccine based on available data. A week later, after Moderna disclosed the decision as well as its own displeasure over the agency position, Prasad’s decision was reversed. He left the FDA at the end of April.
The FDA approved a novel type of treatment for narcolepsy made by Takeda, backing a drug class that scientists hope can transform the treatment of sleep disorders and potentially address a broad range of neurologic conditions, STAT writes. The twice-a-day pill, an orexin receptor agonist that will be marketed as Orzeyful, is likely to be very appealing to patients. Current therapies, stimulants and sodium oxybates, carry risk of misuse, and patients still feel sleepy while taking them. Since the orexin system not only regulates the cycle of sleeping and waking but may also boost attentiveness and cognition, the broader goal for drugmakers is to test the treatments in various neuropsychiatric conditions in which patients feel sleepy and fatigued.
