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Amgen is recalling nine lots of its anemia drug Aranesp after a small number of syringes were found to potentially contain cellulose and/or polyester particles. Read More
Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. Read More
Generics manufacturers Mylan, Momenta and Sandoz have joined Dr. Reddy’s Laboratories as some of the first to announce patent challenges against Teva’s blockbuster multiple sclerosis drug Copaxone in the newer 40 mg version. Read More
A federal court has ruled that generic manufacturer Mylan does not have to recall its already-shipped versions of Hospira’s sedative Precedex, a move that reverses the court’s earlier mandate to recall all existing generic versions of the drug. Read More
The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities. Read More
Aegerion Pharmaceuticals said the FDA has closed out a warning letter stemming from overblown claims its CEO made on TV, but the company still faces a federal investigation and lawsuit surrounding its marketing practices. Read More
Taiwan-based TWi Pharmaceuticals has won final FDA approval for a generic version of Par Pharmaceutical’s AIDS drug Megace ES, but the product’s launch remains on hold as the brandmaker appeals its 2011 patent infringement lawsuit. Read More
European and Canadian trade negotiators reportedly have finalized the text of an historic deal that will bring Canada’s intellectual property regulations for pharmaceuticals closer to those of the EU, although it may take another two years before the agreement is actually implemented. Read More
Teva and AstraZeneca want a consolidated class action lawsuit alleging they conspired to delay generic entry of AstraZeneca’s acid-reflux drug Nexium dismissed, arguing that Teva couldn’t have marketed its version sooner due to approval delays plaguing Ranbaxy, which has 180 days of generic exclusivity on the product. Read More
Drugmakers should consider the effects of price harmonization in the Persian Gulf region when deciding where to launch their products in the global marketplace, a new report concludes. Read More