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The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More
Investigators conducting clinical trials in India could for the first time face up to five years in jail for trial violations if lawmakers approve a proposed bill, a possibility that could further hinder the country’s clinical trials industry, one expert says. Read More
In a closely watched case, a federal judge has denied Celgene’s motion to dismiss a lawsuit alleging the brandmaker engaged in anticompetitive conduct by refusing to turn over product samples for ANDA bioequivalence testing. Read More
With the FDA stepping up scrutiny of data integrity during facility inspections, drugmakers must be ready to answer tough questions about their electronic record system, an inspections expert said. 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 last week issued its 12th warning letter in 2014 for data integrity violations, out of 18 total warning letters released over good manufacturing practices, with foreign facilities drawing most of the criticisms. Read More