News
While it trails Johnson & Johnson’s Tecvayli, Regeneron still hopes Lynozyfic can differentiate in terms of dosing convenience and efficacy.
FEATURED STORIES
Drug pricing, budget cuts, tariffs and other shifts under the Trump administration undermine the biopharma and healthcare ecosystem.
In advance of this week’s CDC vaccine advisory meeting, HHS Secretary Robert F. Kennedy Jr. restacked the committee, claiming problematic industry ties within the previous group. Experts say ACIP had long navigated COIs appropriately and that the new appointees risk the apolitical nature of membership.
The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from sufficient to maintain momentum in the rare disease space.
Job Trends
Biopharma employees reporting a positive business outlook for their companies dropped month over month but increased year over year in February, according to the Glassdoor Employee Confidence Index. Glassdoor’s findings align with recent BioSpace data.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Less than a day into his second term, President Donald Trump ordered a freeze on communications at major public health agencies, among other moves that have sent waves through the biopharma industry.
THE LATEST
The rise of monoclonal antibodies brought back hope for stalling or reversing the devastating neurodegenerative disease. Big Pharma has taken notice with a handful of high-value deals, GlobalData reports.
Digging into a prespecified analysis for the mid-stage study, INmune Bio identified some clinical and biological benefits of its TNF inhibitor in patients with early Alzheimer’s disease who have at least two biomarkers of inflammation.
In an open letter addressing the Trump administration’s proposed budget cuts to HHS, the executives urged Congress to continue “robust federal funding” for scientific research, which they say will help maintain U.S. biotech leadership globally.
In adults 50 and older, Moderna’s flu shot was more than 26% better than an unspecified commercial vaccine. In May, the company pulled its application for a combo flu/COVID-19 shot, saying it would refile following data from this Phase III trial.
As of Apr. 22, Sage had 338 full-time employees, all of whom will be laid off effective Aug. 22. The layoffs were announced a few weeks after Maryland’s Supernus Pharmaceuticals acquired Sage for up to $795 million.
The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside experts.
Changing how biopharmas package their products, how regulators review new drugs and how mutated genes are fixed could make ultrarare disease treatments possible.
The FDA delivered two notable approvals for RSV immunization, UroGen overcame a negative advisory committee vote to secure an approval in bladder cancer, and more key regulatory nods from the past month.
The high court found that members of a task force that determines what preventive drugs must be covered can be removed at will by HHS Secretary Robert F. Kennedy Jr.
The revamped and “more anti-vax skewed ACIP committee” at the CDC “has a bone to pick with mRNA vaccines,” according to Truist Securities analysts. Meanwhile, the FDA moves forward on having Pfizer/BioNTech and Moderna update labels for their COVID vaccines.