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FDA
Merck’s blockbuster anti-PD-1 therapy Keytruda has snagged another regulatory approval from the U.S. Food and Drug Administration. The checkpoint inhibitor has been approved, in combination with chemotherapy, as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.
As we end October and head into November, the Food and Drug Administration (FDA) continues its work. This upcoming week has several PDUFA action dates for drug applications. Here’s a look.
Following several clinical disappointments and declining stock prices over the past year, Celgene tapped Alise Reicin as its new head of the company’s global clinical development unit, with a focus on mid- to late-stage therapeutics.
Mesothelioma is a rare cancer that develops in the lining of the lungs, abdomen, or cardiovascular cavity. A 2017 study reported that the number of people affected by this rare cancer is between 2,400 - 2,800 individuals per year in the United States alone.
AstraZeneca and Merck & Co. presented results at the Presidential Symposium at the European Society for Medical Oncology 2018 Congress held in Munich Germany describing its Phase III SOLO-1 trial of Lynparza (olaparib) in ovarian cancer.
The European Society of Medical Oncology was in full swing this weekend as multiple companies showed off mid- and late-stage assets that could change the way some patients are treated for their cancer. This morning, BioSpace takes a look at some of the announcements.
FDA
This week will have moderate activity by the U.S. Food and Drug Administration (FDA). Although they jumped the gun on Regeneron and Sanofi’s cancer drug, there are still plenty of other decisions being made this week. Here’s a look.
Multiple biotech companies are scheduled to release their quarterly reports next week. BioSpace takes a quick look at some these companies and the announcements they have made through 3Q2018.
The company, with sites in Seattle and South San Francisco, focuses on next-generation oncology therapeutics. It recently completed a portfolio review and decided to focus its energies and existing capital on G100 and abandoned its CMB305 program.
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