After getting shot down by a panel of outside experts, the biotech reported this morning that the agency had formally rejected its application for the low-sodium therapy, demanding a new set of "clinical and non-clinical information" before it could reconsider an approval.
Cornerstone Therapeutics was dealt a setback today, losing an FDA panel vote on whether their new drug for treating low sodium in the blood should be approved. The agency's outside experts voted 5 to 3 against an approval. They also unanimously rejected the use of the drug to treat heart failure patients.
Near the beginning of the year Cornerstone Therapeutics snapped up Cardiokine and its late-stage heart drug lixivaptan for a mere $1 million down and $147 million in back-ended milestones.
Winston-Salem, NC-based Targacept has inked a $75 million licensing pact for Cornerstone Therapeutics' patents and preclinical programs that target nicotinic receptors. But in keeping with the
FDA wants some allergy and asthma drugs to come with a new warning of potential psychiatric problems. In an announcement Friday, the agency said it had asked drugmakers to add cautionary language to
Italy's Chiesi Farmaceutici will buy a 51 percent stake in Cornerstone Therapeutics, a respiratory drug developer, in a deal valued at $70 million. Investors quickly signalled their disapproval of