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Biological manufacturers should submit their lot distribution reports (LDRs) using the same electronic messaging standard as those used for drug registration and labeling content of BLAs, says a new draft guidance on LDR electronic submissions. Read More
San Francisco-based drugmaker Exelixis is halting research into the use of its thyroid cancer therapy Cometriq for treating prostate cancer after the drug failed a Phase III trial for that indication. Read More
Sandoz must wait until a patent on United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin expires in 2017 before it can market a generic version. Read More
Martin Avenue Pharmacy is recalling all of its unexpired sterile preparations and stopping production of sterile drugs after FDA investigators discovered contaminated products and evidence of poor quality control. Read More
Shuttered Boehringer Ingelheim subsidiary Ben Venue continues to create quality headaches for the German manufacturer with the recall of a chemotherapy drug due to a container defect. 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
Biogen Idec said it will launch its multiple sclerosis drug Tecfidera within three months in England and Wales following a final coverage recommendation this week from the UK healthcare pricing watchdog. Read More
Boehringer Ingelheim and Eli Lilly’s type 2 diabetes drug Jardiance has received a preliminary thumbs-down from the UK’s healthcare cost watchdog, which wants to see more cost-effectiveness data comparing the new product with other existing treatments. Read More
Drugmakers operating in Brazil must report all supply chain movements to regulatory authorities in real time, according a new guidance on the country’s drug tracking and tracing system. Read More