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Washington state oncology drug developer OncoGenex is taking back rights to the experimental cancer therapy custirsen, ending a five-year collaboration with Israeli manufacturer Teva Pharmaceuticals. 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
A compounding pharmacy pled guilty recently to manufacturing contaminated products that caused skin infections, the first compounder to be convicted of criminal charges for poor quality since the FDA gained new authority in 2013. 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
Manufacturers are urging the FDA to ax three proposed quality metrics related to annual product reviews that would measure a facility’s quality culture, claiming they are too burdensome, unnecessary and confusing. Read More
The European Union has banned imports of Ranbaxy’s injectable antibiotic cephalosporin following an inspection by German regulators who found the company’s Dewas, India, facility was not in compliance with GMPs. Read More
In 2014 the FDA laid the groundwork for an unprecedented overhaul in the next few years in how the agency will measure pharmaceutical quality and conduct inspections. This is a look back at 2014 and the year ahead. Read More