Committee recommends Merck HIV drug for approval
WASHINGTON The Antiviral Drugs Advisory Committee of the Food and Drug Administration voted unanimously to recommend the approval of Merck’s HIV treatment Isentress (raltegravir). The FDA is not bound to follow the committee’s recommendation, although it typically takes its advice.
Isentress is indicated to treat HIV in patients in which other therapies are not slowing viral replication. If approved, the drug would be the first in a new class of antiretroviral agents.
Shire takes ADHD patch off market
NEW YORK British drug developer Shire PLC is temporarily withdrawing from the market its product that treats attention deficit hyperactivity disorder, Forbes.com reported yesterday.
Shire decided to extract the Daytrana product line from the market after patients and caregivers complained that the patch’s release liner is difficult to detach, a problem for those who are trying to administer the drug. To mitigate the state of affairs, Shire stated they would provide easier-to-use patches to those affected by the market withdrawal.
Meanwhile, American depository shares of Shire fell 42 cents to $78.32 in pre-market trading yesterday. In a separate statement, Noven Pharmaceuticals, creator of Daytrana and other medications, estimated the damages at $4 million to $6 million.
Novo Nordisk announces Gruhn, Soeters to switch places
PRINCETON, N.J. Leading diabetes company Novo Nordisk Tuesday announced the appointment of Jerzy Gruhn as president of Novo Nordisk Inc., the company’s U.S. affiliate, and senior vice president of Novo Nordisk North America.
Gruhn will replace Martin Soeters, who will take up the position as senior vice president of the European region, overseeing the company’s operations in 35 countries. Gruhn is currently vice president of the Eastern Europe region. The appointments will take effect on January 1, 2008.
“We are making these changes at a time when Novo Nordisk is doing well in both Europe and North America and are confident that we have the right leadership to secure our future growth in the two regions,” said Kare Schultz, executive vice president and chief operating officer.
“North America is not only the world’s largest diabetes market, but also a region populated by people passionate about stopping the diabetes epidemic here and around the world,” said Gruhn. “Novo Nordisk will continue to be a leader in changing diabetes by embracing a unique business model that allows us to be socially and environmentally responsible, while achieving fiscal growth to advance diabetes care.”
Martin Soeters has more than 27 years’ experience in Novo Nordisk in executive management, sales and marketing. Since he took over responsibility for the company’s operations in the North American region in 2000 he has grown annual sales from $500 million in 2000 to $2.1 billion in 2006.