Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Source: The GMP Letter
The recent ransomware attacks in the U.S. healthcare industry have highlighted the need for increased product security for medical devices, the American Hospital Association said in a letter to the…
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Source: The GMP Letter
Things are looking up for Massachusetts-based Homology Medicines. Source: BioSpace
The USPTO is paving the way for generic challengers to J&J's prostate cancer drug Zytiga. Source: BioSpace
CARMA Therapeutics is based on technology from the Center for Cellular Immunotherapies at the University of Pennsylvania, and was spun out of the laboratory of Saar Gill, assistant professor of…
The agency would have to furlough about 45 percent of its staff. Source: BioSpace
These stocks have been given a Strong Buy or Buy rating by 80% or more brokers. Source: BioSpace
Investors and analysts have given it some thought and mostly think it's a sensible acquisition. Source: BioSpace
Fresh off its $7B acquisition, Celgene is planning to open a biopharma incubator on its corporate campus in New Jersey. Source: BioSpace