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The Apothecary Shoppe’s facility in Oklahoma has been given a warning letter after an FDA inspection revealed that the firm produces potassium chloride, a drug that appears on the list of drug products that have been withdrawn or removed from the market. Read More
An FDA review into shipments of drugs from a UK company to the U.S. revealed that Wallace Cameron International has not fulfilled its establishment registration and drug listing obligations but continued to manufacture, prepare, propagate and process drugs that were exported to the U.S. Read More
Pfizer presented results from a global Phase III study of Sutent as an adjuvant therapy following surgery for renal cell carcinoma, showing that it extended disease-free survival by more than one year in patients at high risk for recurrence. Read More
A federal judge ruled that Apotex’s biosimilars of Amgen’s Neulasta and Neupogen do not infringe on a patent that covers a protein refolding process. Read More
A federal judge awarded Fresenius a preliminary injunction that blocks Fera Pharmaceuticals from marketing a levothyroxine sodium generic for the treatment of an underactive thyroid. Read More
A federal appellate court upheld a district court dismissal of Mylan’s antitrust case against Warner Chilcott and Mayne Pharmaceuticals, which alleged that the name-brand drugmakers modified their acne treatment Doryx to block generic competition and maintain a monopoly on the market. Read More