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“Over the entire course of its review, the agency did not raise any issues suggesting non-approvability of golodirsen,” said Sarepta CEO Doug Ingram. Read More
Retailers Walmart, Rite Aid, and CVS are pushing back against attempts by Merck, Glenmark and Par Pharmaceuticals to dismiss a federal lawsuit over an alleged antitrust conspiracy over Glenmark’s generic of Merck’s high cholesterol drug Zetia. Read More
Persion Pharmaceuticals has petitioned the FDA to ensure that generics of its Zohydro ER hydrocodone bitartrate extended-release capsules prove their bioequivalence in patients with hepatic impairment. Read More
Syneos called for “guidance on how product should be properly tapered or discontinued, particularly for long-acting opioids or those used for chronic pain.” Read More