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Boehringer Ingelheim and Eli Lilly said Monday that the FDA has accepted their NDA for a first-in-kind drug combination to treat type 2 diabetes. Read More
GlaxoSmithKline said Monday it is under investigation in Poland for allegedly bribing doctors to promote the asthma drug Seretide (fluticasone propionate/salmeterol xinafoate). Read More
Drugmakers want the FDA to soften language in its first guidance on social media marketing that would make companies responsible for third-party content. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to verify that the information used to gain marketing authorization in the EU remains valid in practice. Read More
EU member states will be able to purchase pandemic vaccines and other medical countermeasures as a group, under a new procurement scheme adopted Thursday. Read More
GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More