PHARMACY

Restat appoints new president

BY Alaric DeArment

WEST BEND, Wis. Pharmacy benefit manager Restat has appointed a new president, the private company announced Tuesday.

David Kwasny will assume his new position Wednesday, replacing Michael Clark, who served as president since 1996 and recently retired. Clark will remain on the company’s board as an advisory member with the F. Dohmen Co., Restat’s Milwaukee-based parent company.

Kwasny has been a registered pharmacist for more than 30 years and joined Restat in 1997 after working in community and operational pharmacy management. He previously worked with the Kmart Corp., Health Care Pharmacy Providers, ScriptCard and ProVantage, most recently serving as Restat’s VP sales and marketing.

“Mike Clark has worked tirelessly to grow Restat into one of the strongest prescription service providers in the nation,” Kwasny said. “We will build on that successful legacy with an aggressive plan to continue our strategic growth, generating innovative cost-containment solutions on behalf of the more than 6 million people who rely on Restat for managed pharmacy services.”

The company also made two other executive appointments. After 14 years at CVS Caremark, Terry White will work for Restat as SVP sales and marketing. John Bergan has been appointed COO after serving as VP information technology and operations since 1997.

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PHARMACY

FDA approves fast-track designation for Hodgkin lymphoma treatment

BY Alaric DeArment

BOTHELL, Wash. An investigational drug for treating Hodgkin lymphoma has received fast-track designation from the Food and Drug Administration, the maker of the drug has announced.

Seattle Genetics, based in the Seattle suburb of Bothell, Wash., said it received the designation for SGN-35, for which it hopes to soon start a phase 2 study.

“Receiving fast-track designation is another important component of our regulatory strategy for SGN-35 and a key step for this program,” Seattle Genetics president and CEO Clay Siegall said. “With our pivotal trial underway, we expect data in 2011.”

That year, Siegall said, the company hopes to file for regulatory approval, possibly launching the drug in 2012. So far, the drug has received orphan drug designation in the United States and Europe for Hodgkin lymphoma and anaplastic large cell lymphoma.

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GSK submits study results for HPV, cervical cancer vaccination

BY Alaric DeArment

PHILADELPHIA British drug maker GlaxoSmithKline has submitted data from a phase 3 efficacy study on a vaccine for human papillomavirus and cervical cancer to the Food and Drug Administration, the company announced Monday.

The drug, Cervarix (human papillomavirus vaccine [Types 16, 18] recombinant, adjuvanted, adsorbed), is designed to prevent HPV types 16 and 18. The study, called HPV-008, enrolled more than 18,600 girls and women aged 15 to 25 from 14 countries in North America, Latin America, Europe and the Asia-Pacific region. Cervarix already has approval in more than 90 countries, including the member countries of the European Union, Mexico, Australia, Singapore and the Philippines.

“We are pleased to have reached this significant milestone for Cervarix,” GSK VP and director North American vaccine development Barbara Howe said in a statement. “The data submitted to the FDA reaffirm our confidence in the vaccine’s safety and efficacy profile.”

Merck & Co. already has FDA approval for its vaccine, Gardasil (human papillomavirus quadrivalent [Types 6, 11, 16, 18]).

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