News
An inspection of a facility making Elevar’s rivoceranib uncovered deficiencies, leading the FDA to reject a combination therapy that includes the drug. The rebuff is the third strike for the partners after the agency issued manufacturing-related denials for the other drug in the combo.
FEATURED STORIES
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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The FDA has a few target action dates for the end of the month, although PDUFA dates can sometimes seem like a moving target.
Life sciences organizations and companies strengthen their leadership teams and boards with these Movers & Shakers.
Zealand Pharma shared positive top-line results for its second Phase III clinical trial of its congenital hyperinsulinism (CHI) drug, dasiglucagon, in pediatric patients.
Janssen’s Tremfya, an IL-23 inhibitor, is showing an ability to separate itself from AbbVie’s Skyrizi in preventing the activation of cells that drive inflammation.
On Thursday, Mersana announced that the FDA granted an orphan drug designation to one of its lead assets, XMT-2056, which is intended to treat gastric cancer.
On Wednesday evening, a man in Massachusetts became the first person reported to have a case of monkeypox in the U.S. The man contracted monkeypox after traveling to Canada.
As the American Society of Gene & Cell Therapy’s 25th Annual Meeting wraps up, a host of life science companies touted their research and products. BioSpace looks at some of them.
Pfizer, Sarepta Therapeutics, Genethon and Solid Biosciences are working on gene therapies for Duchenne Muscular Dystrophy. Now, the four companies have teamed up.
U.K. researchers found that the first dose of any vaccine was linked with an initial 12.8% decrease in the odds of Long COVID.
Germany-based Evotec AG forged its third partnership in May, a deal with Spain’s Almirall S.A. to develop new therapeutics for severe diseases of the skin.