Fallout from the resignation of FDA Commissioner Marty Makary continues as several other senior regulators are removed from their posts; pharma’s top paid CEOs make up to 358 times more than their employees; Revolution Medicine’s pancreatic cancer results highlight movement in the deadly disease space; more.
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FDA Commissioner Marty Makary officially resigned last week following reports of his ouster. Then, the acting directors for the agency’s two main review units also left their posts, as did the FDA chief of staff and chief AI officer. While some of these people will remain at the agency in a different capacity, the turnover highlights the continued lack of stability in FDA leadership.
Domino effect aside, the reaction from the industry has been mostly positive, given Makary’s tumultuous reign. But he might be hard to replace. If it were up to the biotech industry, former longtime oncology regulator and short-lived CDER director Richard Pazdur would take the role. For now, FDA Deputy Commissioner for Food Kyle Diamantas is in charge.
Eli Lilly’s David Ricks was the highest paid pharma CEO last year, but J&J’s Joaquín Duato made the most relative to rank-and-file employees, with a median pay ratio of 358 to one. He was on the top of BioSpace’s list last year, too, with a ratio of 293 to 1. On the opposite end of our list, Vertex’s Reshma Kewalramani had a ratio of just 80 to 1. Vertex had the highest median compensation with over $264,000. The CEO, meanwhile, made $21.1 million.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. This week, Truist Securities went so far as to nominate RevMed as “the next oncology titan,” a title currently held by Merck and its blockbuster cancer drug Keytruda. Meanwhile, Actuate Therapeutics and Immuneering are advancing their own pancreatic cancer assets, providing more rays of hope for a devastating malignancy.
Safety continues to challenge the gene therapy space, especially in Duchenne muscular dystrophy. Late last week, REGENXBIO announced mixed results from a Phase 3 program—the gene therapy did lead to functional improvements, but two serious adverse events caused the stock to drop 37%.
Finally, Amgen’s rare disease drug Tavneos continues to face scrutiny. In January, the FDA asked the pharma to pull the drug off the market due to an issue with the data that led to its approval. Amgen denied the request. Then last month, the FDA alleged that doctored data were filed to support Tavneos’ initial approval. Now, it’s been linked to 20 deaths in Japan.
