STAT+: Pharmalittle: We’re reading about HHS canceling a Moderna contract, FDA rejecting a rare disease drug, and more
In today's Pharmalittle roundup, we're reading about HHS canceling a Moderna contract, FDA rejecting a rare disease drug, and more.
Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who taught us that “every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us. Remember, a prescription is not required, so no need to worry about rebates or copayments or all those under-the-hood calculations involved in obtaining a salve. Our choice today is maple pecan. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do keep in touch. We appreciate the outreach …
The Department of Health and Human Services notified Moderna that it is canceling a nearly $600 million contract with the company to develop, test, and license vaccines for flu subtypes that could trigger future pandemics, including the dangerous H5N1 bird flu virus, STAT writes. Though the possibility of a cancellation had been anticipated — the new leadership at HHS told the company in February that it was reviewing the contract, signed with the Biden administration — the move is being seen as a significant blow to the country’s capacity to respond to pandemic influenza. The funding cut is a financial hit that Moderna can ill afford. The company, which in 2021 had a market capitalization of $216 billion, is now worth $10 billion. The value of its stock price plummeted 83% over the last 12 months because of doubts regarding the future sales of its Covid vaccines and the prospects for its experimental vaccines in influenza and cancer. Moderna had also said it no longer expected to receive approval for a combination Covid/flu shot this year, and that it was “deprioritizing” the combination shot for younger adults.
For the past decade, Stealth BioTherapeutics has ridden a roller coaster trying to convince the Food and Drug Administration to approve its ultra-rare disease drug. Now, the company has encountered yet another twist — an unexpected regulatory rejection that will not only delay access and strain its finances, but ensure some of the most vulnerable patients are denied the treatment, STAT tells us. At issue is a medication for Barth syndrome, a rare illness that causes an enlarged heart, muscle weakness, and a shortened life expectancy. The disease afflicts up to 150 people in the U.S., an extremely small number that has, at times, made it difficult for the company and the FDA to find a way to generate enough of the right kind of study data to make the drug available to patients. After an advisory committee last October, the FDA missed a previously scheduled deadline in January to complete its marketing review, pushing a decision to April. But the agency missed that deadline, too. This week, Stealth finally received an update, and the decision is “confusing” and “shocking,” said Stealth chief executive officer Reenie McCarthy. Instead of approving the drug, the FDA rejected the application.
