FDA sets PDUFA date for Cornerstone hyponatremia drug

A hyponatremia treatment from Cornerstone Therapeutics (NASDAQ:CRTX) is now targeted for a regulatory approval decision in the fourth quarter. The U.S. Food and Drug Administration has accepted the new drug application for the compound CRTX 080. The agency set a goal date of a Prescription Drug User Fee Act (PDUFA) date of Oct. 29 to […]


CRTX sells rights to two drugs, shifts focus to drugs sold in hospitals

Cornerstone Therapeutics (NASDAQ:CRTX) has sold rights to two anti-infective products in deals that complete the specialty pharmaceutical company’s shift away from marketing primary care drugs. Cornerstone will now focus on marketing hospital-based drugs. Cornerstone receives an an undisclosed amount of cash for divesting product rights and inventory for the antibiotic treatments Factive and Spectracef to […]


Cardiovascular drug acquisition shows CRTX’s new hospital strategy

The cardiovascular drug candidate developed by Cardiokine was the centerpiece of Cornerstone Therapeutics‘ (NASDAQ:CRTX) acquisition of the drug developer announced last week. But while it’s clear Cornerstone hopes lixivaptan helps fill out its drug portfolio, regulatory approval won’t make Cornerstone the initial beneficiary. That honor belongs to a company that had nothing to do with […]


CRTX respiratory distress drug study draws $10M lawsuit from ONY

Cornerstone Therapeutics (NASDAQ:CRTX) is in the crosshairs of competitor ONY over a published study that concludes its respiratory drug is riskier to infants than Cornerstone’s. Privately held ONY claims damages of $10 million and is now seeking to recover them through a lawsuit that targets Cornerstone; Italian company Chiesi Farmaceutici, which licensed the drug to […]


Covidien executive McBean named president of Cornerstone Therapeutics

Former Covidien (NYSE:COV) executive Kenneth McBean has joined Cornerstone Therapeutics (NASDAQ:CRTX) to become president of the respiratory therapeutics company. The hire comes as Cornerstone puts more emphasis on its branded products and transitions away from sales of unbranded drugs. As Covidien’s vice president and general manager of Specialty Pharmaceuticals from March 2009 through last May, […]


Cold remedy approval expected; CRTX plans to market for cold season

Cornerstone Therapeutics (NASDAQ:CRTX) expects its latest respiratory drug will get U.S. Food and Drug Administration approval in time for the coming cold and flu season. The Cary, North Carolina-based respiratory therapeutics company has received a response from the FDA and Cornerstone is preparing to answer the regulator’s questions. Cornerstone CEO Craig Collard assured analysts that […]


Respiratory pharma Cornerstone has $86M cash, says acquisition coming

Respiratory drugs company Cornerstone Therapeutics (NASDAQ:CRTX) broke $125 million in annual revenue last year helped by the strength of its two biggest selling products, both of them acquisitions from other companies. Cornerstone is now closing in on another deal that could bring yet another product to its portfolio. Cornerstone expects to complete a deal “in […]