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In a win for drugmakers, President Barack Obama signed into law a bill that extends exclusivity periods for new drugs and biologics containing a controlled substance by changing the date they are considered to have been approved from the current FDA sign-off to when the Drug Enforcement Agency schedules them for sale. Read More
Fabre-Kramer Pharmaceutical’s depression candidate gepirone could be held back yet again in its fourth go-around, with the FDA questioning whether two successful trials are enough to prove its value alongside a “relatively large” number of negative trials. Read More
EC Expands Label for Pfizer’s Xalkori Lysogene Gains Orphan Drug, Rare Pediatric Disease Designations FDA Holds Public Meeting on Patient-Focused Drug Development for Psoriasis Cellceutix Gains FDA Fast Track for Oral Mucositis Candidate Exelixis Awarded EC Approval for Cotellic for Metastatic Melanoma Read More
The FDA has hit three more compounders — two in California and one in North Carolina — with warning letters, bringing to 25 the number of warnings issued to this industry this year. Read More
Turing Pharmaceuticals has flip-flopped on its decision to reduce the list price of Daraprim, instead offering discounts of up to 50 percent to hospitals, as well as other minor adjustments to help patients afford the drug, which has skyrocketed in price from $13.50 a pill to $750. Read More
Par Pharmaceutical’s efforts to litigate its way to a generic version of Adderall XR ended with a whimper Tuesday, after a federal judge barred the company from challenging Shire’s patents on the drug. Read More