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Swiss Precision launches pregnancy test that also provides an estimate of time since ovulation

BY Michael Johnsen

PETIT LANCY, Switzerland — Swiss Precision Diagnostics recently launched its Clearblue Advanced Pregnancy Test with Weeks Estimator — the first and only pregnancy test that also provides an estimate of time since ovulation for women testing pregnant — into the U.S. marketplace.

As with other home pregnancy tests, the Clearblue Advanced Pregnancy Test with Weeks Estimator detects hCG, the hormone produced early in pregnancy and excreted in the urine. Uniquely, in addition to detecting hCG, the Clearblue Advanced Pregnancy Test with Weeks Estimator also measures the level of hCG to estimate time since ovulation.

The Weeks Estimator feature assumes ovulation occurred on the day after the urinary luteinizing hormone surge and works on a threshold basis of urinary hCG levels: there are three time bands that give an estimate of one to two, two to three, and three or more weeks. These thresholds are based on extensive research of urinary hCG rise in early pregnancy, the company reported. 

The Clearblue Advanced Pregnancy Test with Weeks Estimator gives an estimate of time since ovulation that is 93% in agreement with time since ovulation is relative to the LH surge.

 

 

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FDA approves Galderma’s Mirvaso for redness of rosacea

BY Alaric DeArment

FORT WORTH, Texas — The Food and Drug Administration has approved a drug made by Galderma Labs for treating a side effect of rosacea in adults, the company said.

Galderma announced the approval of Mirvaso (brimonidine) topical gel in the 0.33% strength for the topical treatment of facial erythema of rosacea. The drug is applied once per day to reduce redness and lasts up to 12 hours. The company expects the drug to become available in pharmacies next month.

"Facial redness is the most common symptom of rosacea, but until now, physicians have been without prescription treatment options to specifically address this patient need," University of Louisville medical professor and lead investigator in the late-stage clinical trials of the drug Mark Jackson said. "The FDA approval of Mirvaso marks a turning point in rosacea treatment: We are now able to provide patients who deal with the daily frustrations caused by the redness of rosacea with an effective therapy."

 

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McKesson Specialty Health names new chief medical officer

BY Michael Johnsen

THE WOODLANDS, Texas — McKesson Specialty Health and The US Oncology Network on Wednesday announced the appointment of Michael Seiden as chief medical officer, effective Sept, 22. 

"Dr. Seiden’s distinguished track record and extensive experience across patient care, research and operations makes him uniquely qualified to lead our organization’s clinical and physician engagement strategy," stated Marc Owen, president, McKesson Specialty Health. "His experience as a practicing oncologist and in running a major cancer center will complement the existing leadership team and ensure that a physician’s perspective is contemplated in all decisions."

In his new capacity, Seiden will lead McKesson Specialty Health’s clinical strategy and work closely with physicians in The US Oncology Network and other community practices across the country to enhance the delivery of high-quality, evidence-based care.

"Dr. Seiden’s expertise will be beneficial in driving The US Oncology Network’s vision of improving patient outcomes and quality of life," added Steven Paulson, president and chairman of the board for Texas Oncology, a practice affiliated with The US Oncology Network. "Physicians from The US Oncology Network participated in the candidate search which led to Dr. Seiden’s appointment, and we are pleased to welcome him to the organization."

Until recently, Seiden served as the CEO and president of Fox Chase Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center research facility and hospital in Philadelphia. Under his leadership, Fox Chase merged with Temple University Health system in 2012. Prior to Fox Chase, Seiden spent many years practicing at Massachusetts General Hospital, where he served as chief of the Clinical Research Unit, Cancer Science Division. A nationally known expert on ovarian cancer, Seiden has been a practicing oncologist for more than 20 years.

Seiden received his bachelor’s degree from Oberlin College and his medical and Ph.D. degrees from Washington University. He completed his residency at Massachusetts General Hospital, his fellowships in medical oncology and bone marrow transplant at Dana Farber Cancer Institute, and his post-doctoral fellowship at Brigham and Women’s Hospital, Department of Pathology.

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