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Gilead, Myriad Top J.P. Morgan’s 2009 Short List

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA decision on AMAG’s iron therapy ferumoxytol is also key event for small-cap biotech this year.

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New Drug Approvals & Regulatory Updates, In Brief

Solvay's swine-based pancreatic enzyme product approved with REMS: On May 1 FDA granted Solvay Pharmaceuticals' Creon (pancrelipase) the first pancreatic enzyme insufficiency product approval under guidelines that bring the previously unregulated remedies under the FDA umbrella. At the same time the agency made clear its concerns for the class by requiring that CREON have a Risk Evaluation and Mitigation Strategy. As part of the classwide REMS, caregivers and patients are to receive a Medication Guide with dosing and safety information that emphasize the risk of fibrosing colonopathy, a rare adverse reaction in cystic fibrosis patients taking high doses of pancreatic enzyme replacement therapy, as well as the dangers of over- or under-dosing. It also notes the theoretical risk of cross-species infection with porcine viruses because Creon and similar products are derived from pig pancreases (1"The Pink Sheet," Dec. 8, 2008, p. 6). FDA-approved Creon will be available in the third quarter, but the 20-year-old currently marketed formulation will remain available until the launch, the company said

New Drug Approvals & Regulatory Updates, In Brief

Solvay's swine-based pancreatic enzyme product approved with REMS: On May 1 FDA granted Solvay Pharmaceuticals' Creon (pancrelipase) the first pancreatic enzyme insufficiency product approval under guidelines that bring the previously unregulated remedies under the FDA umbrella. At the same time the agency made clear its concerns for the class by requiring that CREON have a Risk Evaluation and Mitigation Strategy. As part of the classwide REMS, caregivers and patients are to receive a Medication Guide with dosing and safety information that emphasize the risk of fibrosing colonopathy, a rare adverse reaction in cystic fibrosis patients taking high doses of pancreatic enzyme replacement therapy, as well as the dangers of over- or under-dosing. It also notes the theoretical risk of cross-species infection with porcine viruses because Creon and similar products are derived from pig pancreases (1"The Pink Sheet," Dec. 8, 2008, p. 6). FDA-approved Creon will be available in the third quarter, but the 20-year-old currently marketed formulation will remain available until the launch, the company said

Peace On Commerce, Good Will To Dingell

Rep. John Dingell, D-Mich., will be the lead sponsor of national health care legislation emanating from the House Energy and Commerce Committee in the 111 Congress that begins Jan. 6

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