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Although the FDA has rejected Stealth’s new drug application for Barth syndrome candidate elamipretide, the agency identified a potential accelerated approval pathway. The company has pared down its staff to conserve resources to fund a potential resubmission.
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As sales of its COVID vaccine plummet, Novavax is looking ahead toward other novel vaccines, brought to market with the help of the company’s pharma partners—something it opted not to do as the pandemic swept the globe in 2020.
A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer them found that 2024 was the busiest year yet. Companies have disclosed spending $513 million on vouchers that were earned in 2024 so far.
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors.
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GSK’s dealmaking will be “cautious and disciplined” under the current trade war, but the pharma will focus on looking for “opportunities created” amid these tensions, according to CEO Emma Walmsley. The company also reported a 4% earnings bump for the quarter.
It’s been a fraught road for the proposed merger between Acelyrin and Alumis, with Tang Capital’s Concentra Biosciences in February threatening to upend the deal with a proposed $3-per-share acquisition of Acelyrin.
As Q1 2025 earnings season continues, tariffs remain top of mind for pharma CEOs and investors. Meanwhile, the American Association for Cancer Research’s annual event kicks off this year’s oncology conference season. Plus, will the FDA become politicized under HHS Secretary RFK Jr.?
What a CEO makes can be staggering from the seat of a rank-and-file employee, whose pay is typically in the five-to-six digit range.
Policy uncertainties are impacting biopharma dealmaking from continent to continent, with companies being asked to walk a tightrope on their relations with China.
Nevertheless, Albert Bourla has been lobbying the U.S. government—as high as President Donald Trump himself—to skip the pharmaceutical industry tariffs, which Trump has threatened, in part as a way to shore up U.S. national security.
Despite executing perfectly, Octagon confronted a “scientific no-go,” CEO Isaac Stoner said in his LinkedIn post announcing the company’s impending closure.
Vas Narasimhan said on Tuesday that if the U.S. adopts international drug pricing, all companies would have to “relook at their medium- to long-term outlook.”
Following the recent discontinuations of assets in Alzheimer’s and migraine, AstraZeneca is stepping away from neuro altogether.
Biohaven will use the money to bankroll commercial preparations for the spinocerebellar ataxia drug candidate troriluzole, which is currently under FDA review with a decision expected in the third quarter.