PHARMACY

Clifton Louie named First DataBank executive vp and COO

BY Drew Buono

SAN BRUNO, Calif. Clifton Louie, former executive director of clinical services at the University of California at San Francisco Medical Center, has joined First DataBank as executive vice president and chief operating officer. The company provides drug databases that are used within information systems in every aspect of the healthcare industry.

Louie, while at UCSF, also served as associate dean for the school of pharmacy, where he was responsible for management of multiple departments within UCSF Medical Center including pharmaceutical services, clinical laboratories and health information management services. In addition to his work at the school, Louie held the position of McKesson chairman for pharmaceutical information technology, where he was a key figure in developing the rules, design and implementation of a multiyear plan to advance physician order entry.

According to Don Nielsen, president of First DataBank, “As First DataBank continues to design drug information databases to address such industry issues as electronic health records, e-prescribing and physician order entry, Cliff’s expertise and leadership will be invaluable in advancing our efforts.” He also has been considered an industry expert in the use of technology to enhance patient safety and capacity of pharmaceutical care. “His remarkable record of achievement in improving the quality and safety of patient care speaks for itself,” Nielsen noted.

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Mylan, Forest get FDA approval of Bystolic for hypertension

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved Mylan and Forest Labs’ new drug, nebivolol, for the treatment of high blood pressure. Forest will market the drug under the prescription name Bystolic.

Nearly 1-in-3 adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack and kidney failure. “High blood pressure is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” said Douglas Throckmorton, the FDA’s deputy director of the Center for Drug Evaluation and Research. “Bystolic offers a new treatment option for people who need to control their high blood pressure.”

More than 2,000 people received Bystolic during clinical trials. The drug’s efficacy was similar to that of other approved beta blockers, the FDA said. The most common reported side effects were headache, fatigue, dizziness and diarrhea.

On Dec. 2 of this year, Forest and Mylan had said that final approval was contingent upon resolution of manufacturing deficiencies at a plant in Belgium.

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Genzyme gets expanded approval for Thyrogen from FDA

BY Drew Buono

CAMBRIDGE, Mass. The Food and Drug Administration has granted expanded approval for Genzyme’s thyroid cancer drug Thyrogen, according to published reports.

The new indication allows for Thyrogen (thyrotrophin) to be used in combination with radioiodine, a radioactive iodine used to treat thyroid cancer, to destroy the remaining thyroid tissue in patients who have had their cancerous thyroids removed.

Thyrogen was initially approved in the U.S. in 1998 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The drug helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal.

“This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence,” said Mike Heslop, senior vice president and general manager of Genzyme’s endocrine business.

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