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The European Medicines Agency said Monday it has concluded its investigation into deficient postmarket reporting by Roche and forwarded a report to the European Commission, where penalties will be debated. Read More
The UK’s National Institute for Health and Care Excellence has recommended Ferring Pharmaceuticals’ Firmagon as a cost-effective treatment for advanced hormone dependent prostate cancer in people with spinal metastases and signs or symptoms of spinal cord compression. Read More
The FDA has approved another under-the-tongue hay fever treatment, putting a second product on the market that will replace the routine injections currently prescribed to control symptoms. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American drugmakers. Read More
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
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