News
Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
FEATURED STORIES
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
THE LATEST
No Patient Left Behind says that drug value assessments used in countries like Canada and Germany undervalue innovative medicines by 90% and mislead U.S. policymakers into thinking Americans are overpaying.
After multiple rounds of layoffs that cut Kronos down to just 10 people, the small molecule biotech has accepted a buyout offer from Kevin Tang’s Concentra Biosciences.
As the Trump administration—including HHS Secretary Robert F. Kennedy Jr.—plays fast and loose with scientific studies and facts, there may be a more sinister force at play: censorship.
Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as per the Associated Press. Some food scientists involved in testing will also be reinstated.
In an internal memo, the World Health Organization signaled its support for anti-obesity drugs like Wegovy and Zepbound, which the agency decided against listing in 2023, the last time the Essential Medicines list was updated.
Like fellow Big Pharmas Eli Lilly and Johnson & Johnson, Amgen is urging the Trump administration to consider tax policy instead of tariffs to promote domestic pharma manufacturing.
Eli Lilly CEO David Ricks is confident that weight loss med Zepbound is gaining market share at the expense of Wegovy, even as its rival strikes deals with CVS and Hims & Hers pharmacies.
The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and less affordable,” according to vaccine expert Paul Offit. It could also further complicate the picture for companies like Novavax.
Announcing first-quarter results, Biogen CEO Chris Viehbacher admitted that tariffs are “a new topic for us,” but said he does not expect major impacts—at least for 2025.
Global employee engagement fell two percentage points in 2024, according to Gallup, while BioSpace found that workforce sentiment decreased among biopharma professionals. Additionally, a recent BioSpace poll suggests engagement could continue to decline in 2025.