We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A recent FDA inspection of contract research organization GVK Biosciences’ Hyderabad, India, plant turned up no evidence of safety or efficacy concerns with US-bound generic therapies, a finding that is in sharp contrast to initial conclusions reached by European inspectors. Read More
Sandoz’s bid to invalidate two patents protecting Amgen’s biologic rheumatoid arthritis therapy Enbrel was dealt a major blow last month after a federal appeals court affirmed that a patent challenge prior to submission of a biosimilar application is premature. Read More
Apotex’s application for a biosimilar version of Amgen’s chemotherapy Neulasta has been accepted by the FDA, one of several recent signs that regulatory movement on approving the therapies is gaining momentum. Read More
In a preview of how the FDA’s Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early in the review cycle. Read More
The FDA moved one step closer to clearing the first biosimilar in the U.S. after agency staff recommended approval of Sandoz’s chemotherapy side-effect drug Zarzio, a version of Amgen’s blockbuster Neupogen. Read More
Halozyme Therapeutics’ pegylated recombinant human hyaluronidase last month won orphan drug designation for pancreatic cancer from the European Medicines Agency, marking the therapy’s second orphan drug win in 2014. Read More
Development and approval times of central nervous system drugs that treat conditions such as depression, Alzheimer’s and Parkinson’s disease lag behind those of other drugs, a recent report finds. Read More
A UK financial watchdog slammed Celgene’s pancreatic cancer drug Abraxane as too expensive and recommended against the English government reimbursing the therapy. Read More
The FDA wants everyone to know that it doesn’t have a drone program in place, nor is it exploring the technology for inspections or surveillance. Read More