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Just a few days after FDA Commissioner Makary resigned, ally Tracy Beth Høeg is also leaving the agency. Her departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug.
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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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In late May, a patient died after receiving Rocket Pharmaceuticals’ investigational gene therapy for Danon disease, spurring the hold. After lowering the dose and changing the regimen of immune modulators patients receive, the company has received FDA clearance for the trial to continue.
The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new guidance follows the surprising return of CBER Head Vinay Prasad, who has previously argued for prioritizing OS.
With its structural changes, CSL expects to generate $500 to $550 million in annualized savings over the next three years.
Regulations aiming to lower the cost of vital medicines will instead end up restricting access and disincentivizing R&D.
The CDC no longer recommends COVID-19 vaccines for healthy children and healthy pregnant women, a position that has been opposed by leading medical societies.
A draft copy of an upcoming MAHA report reveals a strategy in lockstep with recent HHS actions such as reviving the Task Force on Safer Childhood Vaccines; Viking Therapeutics reports robust efficacy from mid-stage oral obesity candidate but is tripped up by tolerability concerns; Novo Nordisk wins approval for Wegovy in MASH; and Lilly takes a pricing stand.
Media coverage can help biopharma executives connect with, inform and inspire the public. In this column, Kaye/Bassman’s Michael Pietrack and three communications experts share how to make the most of these opportunities.
The Trump administration’s ever-changing tariffs and Most Favored Nation drug pricing are part of a blizzard of unclear, potentially illegal tactics that leave observers throwing their hands in the air.
Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset.
Drugs are being invented and manufactured right here in the U.S. by Americans, for Americans. So why doesn’t the industry hold the same respect as steelworkers or other all-American pursuits?