|FDA Cancels Repligen (RG1068) Advisory Committee Meeting; FDA Votes in Favor of HeartWare® Ventricular Assist System|
|By Staff and Wire Reports|
|Thursday, 26 April 2012 19:09|
Repligen Corporation (NASDAQ:RGEN) announced the FDA notified the Company that the FDA Advisory Committee meeting previously scheduled for May 31 to review RG1068 for pancreatic imaging has been cancelled by the FDA. The Company expects to receive a Complete Response letter on the previously announced June 21 PDUFA date requesting additional clinical trial data to support the New Drug Application (NDA).
While we are disappointed in this result, we continue to believe that RG1068 is a safe and effective agent for imaging of the pancreatic ducts, and that it has the potential to meet a significant unmet patient need, stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. We intend to continue our dialogue with the FDA to assess a potential path forward for RG1068.
RG1068 is a synthetic version of human secretin which was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. On December 21, 2011 we filed a NDA, and on February 21, 2012, the FDA accepted the filing of our NDA and granted it priority review based on its prior Orphan Drug and Fast Track designations. Under the Prescription Drug User Fee Act (PDUFA), the FDAs goal for completing review of the NDA is June 21, 2012.
On March 5, 2012 we submitted an MAA to the EMA, which has been successfully validated for full review by the EMAs Committee for Medicinal Products for Human Use. The U.S. and EU marketing applications are based on positive outcomes from a re-read of our Phase 3 clinical study, supporting the use of RG1068 in combination with MRI to improve detection of pancreatic duct abnormalities in patients with known or suspected pancreatitis.
HeartWare International, Inc. (NASDAQ:HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, announced the FDA Circulatory System Devices Advisory Committee voted 9 to 2 that the benefits outweigh the risks for the use of the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.
"We are pleased with the panel's strong recommendation and would like to thank them for their thoughtful review of the data presented from the ADVANCE study," said Doug Godshall, CEO and President of HeartWare. "The Advisory Committee meeting outcome represents an important step toward approval of the HeartWare® Ventricular Assist System in the United States, and we look forward to continuing our dialogue with the FDA as it finalizes its review of our PMA. HeartWare remains committed to optimizing outcomes for patients with end-stage heart failure and looks forward to expanding the clinical experience for the device in the future."
The Advisory Committee's recommendation, while not binding, will be considered by the FDA in its review of the Premarket Approval (PMA) application that HeartWare submitted for the HeartWare®Ventricular Assist System in December 2010.
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Celgene Corporation (NASDAQ: CELG) reported Non-GAAP net product sales of $1,245 million for the first quarter of 2012, a 17 percent increase from the same period in 2011.
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Colgate-Palmolive Company (NYSE:CL) today reported worldwide Net sales of $4,200 million in first quarter 2012, an increase of 5.0% versus first quarter 2011.
CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced the initiation of a Phase 2 clinical trial evaluating the preliminary efficacy and safety of INNO-206 in patients with advanced pancreatic ductual adenocarcinomas (PDA) who have progressed after receiving two prior therapies.
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Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the quarter ended March 31, 2012.
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Repligen Corporation (NASDAQ:RGEN) announced today that midday yesterday, the FDA notified the Company that the FDA Advisory Committee meeting previously scheduled for May 31 to review RG1068 for pancreatic imaging has been cancelled by the FDA.
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