People In Brief
This article was originally published in The Gray Sheet
Executive Summary
Bayer and Thermo CEOs: Thermo Fisher Scientific CEO Marijn E. Dekkers has resigned to take the CEO post of pharmaceutical giant and glucose monitor maker Bayer. Dekkers will not take the helm of Bayer until Oct. 1, 2010, when current CEO Werner Wenning retires. But laboratory equipment manufacturer Thermo announced that its Chief Operating Officer Marc N. Casper will be promoted to CEO next month. Dekkers will join Bayer's board in January and will transitionally become CEO of Bayer's health care unit, which houses the firm's drug and diabetes products, when Bayer HealthCare CEO Arthur J. Higgins leaves the company in the first half of 2010. Bayer also announced that its chief financial officer, Klaus Kühn, will retire next April
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Business In Brief
CHMP recommends approval of Nycomed's Daxas: Nycomed's chronic obstructive pulmonary disorder therapy Daxas (roflumilast) received a recommendation for approval from the European Medicines Agency's Committee for Medicinal Products for Human Use, the company announced April 23. Daxas is recommended for maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50 percent predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. CHMP is all but tantamount to full EU approval and Nycomed expects to launch the drug later this year. If Daxas gains marketing authorization there, it would be the first in a new class of oral agents for COPD. The drug is not faring as well in the U.S., however. On April 7, FDA's Pulmonary-Allergy Drugs Advisory Committee recommended against approval of Daxas (1"The Pink Sheet" DAILY, April 7, 2010)
People In Brief
Schultz the consultant: Former CDRH Director Daniel Schultz has joined Greenleaf Health as senior VP for medical devices and combination products, the consulting firm announced Jan. 6. Schultz left the device center in August as the new FDA leadership reassessed past CDRH device review practices, which have come under intensifying public criticism (1"The Gray Sheet" Aug. 17, 2009). He had led the center for five years and worked at CDRH for 15 years. Greenleaf is developing into a regular landing spot for recently departed top FDA officials. Taryn Fritz Warpole, former deputy chief of staff, joined the firm in July and former Commissioner Andrew von Eschenbach signed on as a senior advisor in March (2"The Gray Sheet" March 9, 2009). Former FDA Chief of Staff Patrick Ronan founded the consulting practice
People In Brief
Schultz the consultant: Former CDRH Director Daniel Schultz has joined Greenleaf Health as senior VP for medical devices and combination products, the consulting firm announced Jan. 6. Schultz left the device center in August as the new FDA leadership reassessed past CDRH device review practices, which have come under intensifying public criticism (1"The Gray Sheet" Aug. 17, 2009). He had led the center for five years and worked at CDRH for 15 years. Greenleaf is developing into a regular landing spot for recently departed top FDA officials. Taryn Fritz Warpole, former deputy chief of staff, joined the firm in July and former Commissioner Andrew von Eschenbach signed on as a senior advisor in March (2"The Gray Sheet" March 9, 2009). Former FDA Chief of Staff Patrick Ronan founded the consulting practice