PHARMACY

Hospira announces investor conference

BY Alaric DeArment

LAKE FOREST, Ill. — Generic drug maker Hospira will have its investor conference next week, the company said Tuesday.

The drug maker, based in the Chicago area, will have the investor day at its headquarters on Dec. 5. Hospira specializes in manufacturing injectable generic drugs, including biosimilars for the European market.

The event will include slide presentations, and the company will stream it via audio webcast at its investors website, hospirainvestor.com.

 

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QRxPharma refiles application for oxycodone, morphine combination pill Moxduo

BY Alaric DeArment

BEDMINSTER, N.J. — QRxPharma has resubmitted its regulatory approval application for an opioid painkiller for which it has sought Food and Drug Administration approval since 2011, the company said Tuesday.

The Australian drug maker announced the resubmission of its application for Moxduo, a pill that combines oxycodone and morphine.The FDA is expected to schedule an advisory committee meeting to review the application for May 2014.

"We are confident that our refiled [new drug application] will confirm the validity of the data defining the product’s respiratory safety advantages, and we are hopeful that the FDA will view them favorably in their consideration of the benefits of immediate-release Moxduo as a therapeutic option for the millions of patients who suffer from acute pain," QRxPharma CEO and managing director John Holaday said.

 

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FDA accepts Purdue Pharma’s application for Targiniq

BY Alaric DeArment

STAMFORD, Conn. — The Food and Drug Administration has accepted Purdue Pharma’s regulatory approval application for a new opioid drug, Purdue said Tuesday.

The drug maker announced the FDA’s acceptance of its application for Targiniq (oxycodone hydrochloride; naloxone hydrochloride) controlled-release tablets. The drug combines oxycodone with the opioid agonist nalxone.

"This milestone brings us closer to offering an important treatment option for the management of chronic pain," Purdue SVP research and development Gary Stiles said. "It also represents another step forward in our effort to develop an array of products that incorporate abuse-deterrent features."

 

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