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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
Australia and New Zealand have abandoned plans for a joint drug and device regulatory authority, although both countries say they will continue to cooperate on mutually beneficial regulations. Read More
China has agreed to streamline its regulatory processes and cut red tape for imports of new drugs, a move that should benefit the U.S. pharmaceutical industry, the U.S. Commerce Department says. Read More
The FDA has acquiesced to industry concerns and promised not to take action against drug supply chain companies for failing to exchange product information before May 1. Read More