Data Integrity Issues Continue To Haunt Industry
Data-integrity issues featured frequently in a record number of FDA warning letters last year related to GMP violations.
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A patent-litigation settlement that Teva has reached with Ironwood and Allergan over Linzess will allow the Israeli firm to enter the US market with the linaclotide-based constipation treatment ahead of major rivals Mylan, Sandoz, Sun Pharma and Aurobindo.
Patent-litigation settlements reached almost 20 years ago in the UK over GSK’s Seroxat paroxetine antidepressant may contravene EU competition law, an advocate general has advised the CJEU.