News
The FDA Adverse Event Reporting System, which Commissioner Marty Makary called “clunky,” previously published updates on a quarterly basis.
FEATURED STORIES
After a slow 2024, the biotech shell company Concentra Biosciences is back, offering to buy four biotechs in the past month and seven so far this year.
Sarepta’s troubles had nothing to do with Arrowhead’s assets, and yet both companies have seen their stock prices decline this past month. BioSpace caught up with Arrowhead’s Chris Anzalone to talk about the biotech’s role as an RNAi pipeline savior.
Leaders at Eli Lilly believe heavy investment in the company’s manufacturing footprint “sets a high standard that newcomers may find challenging to match.” At least one of those newcomers disagrees.
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MassBio’s new report outlines several concerns, including NIH cuts undermining the research engine, FDA reductions delaying innovation and trade barriers disrupting supply chains.
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Read our takes on the biggest stories happening in the industry.
If the attention generated by BioSpace’s coverage of this landmark approval is any indication, Americans are hungry for non-opioid pain treatments that could help quell the still raging opioid epidemic.
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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?
The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can be a goldmine for smaller companies. But it also has a unique set of challenges.
The small molecule, vatiquinone, had already flunked a Phase III trial, but the company pushed ahead with an approval bid anyway.
Viking Therapeutics’ VK2735 achieves a 10.9% placebo-adjusted weight loss at 13 weeks, but a less than ideal safety profile marred the results.
A new study in JAMA contradicts a series of statements made by HHS Secretary Robert F. Kennedy Jr. that paint vaccine advisory committees at the CDC and FDA as hopelessly corrupt.
The FDA has postponed its decision date for Regenxbio’s Hunter syndrome gene therapy to review additional longer-term clinical data for the asset.
Adaptive and Genentech first partnered in 2018 to advance T cell receptor-based therapies for cancer.