BioSpace News Archive

The company disclosed late Monday that the U.S. Food and Drug Administration placed a clinical hold on its proposed gene therapy treatment for methylmalonic academia.

Two months after Pfizer and Astellas’ Xtandi won regulatory approval for a new indication in prostate cancer, the companies have released positive new data in another type of prostate cancer.

Each year, BioSpace evaluates biotech startups for the last year and applies an algorithm that includes funding, collaboration, the state of their pipeline and editorial awards for innovation.

The microbiome is the trillions of microorganisms that live in and on the body. Although it makes complete sense that these would play a factor in gastrointestinal diseases, such as Crohn’s and colitis, it’s less obvious that it would play a role in anything ranging from lung diseases to neurodegenerative diseases.

In an analysis of the proposal, Regulatory Focus, the publication of the Regulatory Affairs Professional Society, noted that the FDA, under the proposal, could see $6.2 billion in overall funding.

Ask yourself these questions to get an idea of whether a new job should be in your near future.

“We appreciate Merck’s willingness to work with us on the advancement of plasma kallikrein inhibitors for DME, and we respect their decision not to move forward,” said Andrew Crockett, KalVista’s chief executive officer.

Savvy job seekers know that networking is the most effective way to find a new job, and the brightest among them have a secret weapon to make them memorable – networking cards.

The FDA gave tentative approval for the drug in 2018, but the holdup was over patent issues.

In 2014, Exelixis’ Cabometyx (cabozantinib) failed to show survival benefit as a monotherapy in prostate cancer.