News
The FDA has informed Merck, Sanofi and AstraZeneca of the safety investigation into their RSV antibodies, though it remains unclear what regulatory action, if any, will be taken.
FEATURED STORIES
At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
Job Trends
Where thousands of former Health and Human Services employees will work next is unknown, but biopharma companies likely aren’t the main destination. Two biopharma executives discuss potential landing spots.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
This year saw lofty highs and devastating lows for neuroscience drug developers like Bristol Myers Squibb, Eli Lilly and AbbVie, following the predictable pattern of successes and failures that characterizes this space.
THE LATEST
Høeg is the fifth person to lead the Center for Drug Evaluation and Research this year.
In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for new approach methologies (NAMs) development.
For the second month in a row, job postings on BioSpace increased in key biopharma disciplines. However, application rates also increased.
Job listings in the area have ticked up in the last month. These seven companies are hiring in South San Francisco right now, including scientist and clinical roles.
Six months after receiving a surprise rejection due to what the FDA called “lack of substantial evidence of effectiveness,” Capricor’s cell therapy deramiocel showed significant benefits in upper-limb function and slowed decline in cardiac function in a Phase III trial.
Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Analysts had noted “unease” from investors regarding the state of the Phase III ADEPT-2 trial, with BMS at one point telling Leerink Partners that the reopening of enrollment would be a “significant development.”
The Phase III, open-label extension study suggests EPX-100 has a “positive” risk/benefit profile for the treatment of Dravet syndrome, analysts at H.C. Wainwright & Co. said Tuesday.
For certain monospecific antibodies, three-month toxicology studies plus other supportive evidence will suffice, eliminating the need for six-month testing.
Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the 2025 Clinical Trials on Alzheimer’s Disease conference continues following two disappointing readouts; and Novo Nordisk’s amycretin yields promising weight loss results.