News
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.
FEATURED STORIES
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
With data from a mid-stage trial showing weight loss of up to 12.3% at 28 weeks in patients treated with PF’3944, “Pfizer is moving full speed into obesity clinical development,” BMO Capital Markets said Tuesday.
DS-9606 was supposed to be the first antibody-drug conjugate in Daiichi Sankyo’s line of anti-cancer assets to use a modified pyrrolobenzodiazepine payload.
The alliance will add to Roche’s RNAi efforts, which include the hypertension candidate zilbesiran, partnered with Alnylam under a July 2023 agreement.
While CagriSema bested Novo Nordisk’s Wegovy on blood sugar control in a late-stage trial, the next-gen weight loss drug still has not met the pharma’s 25% weight loss goal.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
After suffering in the wake of expired tax incentives for pharmas, the island is trying to take advantage of geopolitics to grow its drug manufacturing sector.
While GSK did not provide a specific reason for returning Wave Life Sciences’ WVE-006, the decision comes after the asset in September 2025 came below analyst expectations in a Phase Ib/IIa AATD study.
The facility, which is part of Lilly’s $50 billion reshoring drive, will make obesity drugs such as tirzepatide and retatrutide when it starts operations in 2031.
Sanofi will take venglustat to regulators for Gaucher disease but an application for Fabry disease is less clear after the failure of a Phase III trial.
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the design of their facilities.