Hello, everyone, and how are you today? A steely gray sky is hovering this morning over the Pharmalot campus, where the official mascot is romping about in search of creatures and commuter traffic is humming by. As for us, we are foraging for interesting stories and quaffing cups of stimulation, as you might have guessed. Our choice today is the ever-flavorful pumpkin spice. And you? Is your schedule filled with meetings and deadlines and what-not? To help you along, here are some tidbits. Hope you conquer the world, and do keep us in mind when you see something fascinating. …
Emergent BioSolutions, which makes Narcan, a nasal-spray form of naloxone, said the U.S. Food and Drug Administration fast-tracked an application it submitted for an over-the-counter version of its widely used opioid-reversal nasal spray, The Wall Street Journal writes. The company said the priority review gives the drug an expected approval date of March 29, 2023, putting it first in line for approval ahead of rivals that announced a planned foray into the market. The FDA has encouraged companies to apply for approval for over-the-counter versions of overdose-reversal medications to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.
Express Scripts will put “multiple” biosimilar versions of Humira, the expensive rheumatoid arthritis drug from AbbVie, in the “same position” as the brand-name medicine on its formulary in 2023, Forbes notes. Humira, approved by the FDA 20 years ago, has been one of the nation’s costliest drugs, generating more than $20 billion in sales in 2021 alone. Express Scripts said Humira, which treats inflammatory and skin conditions, is one of the most widely used specialty medications, which account for just 2% of prescriptions but drive half of drug spending. OptumRx, another large pharmacy benefit manager, also plans to take the same step.
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