PHARMACY

Taro reports rise in Q1 sales

BY Allison Cerra

HAWTHORNE, N.Y. — Taro realized a 21% increase in net sales for its first quarter, the drug maker said.

The company said it raked in net sales of $107.7 million, an increase of $18.7 million. Diluted earnings per share totaled 58 cents, compared with 21 cents in the prior-year period.

Operating income for Taro increased 84.4% to $33.4 million, or 31% of net sales, compared with $18.1 million, or 20.3% of net sales, in 2010.

During the period, Taro received three abbreviated new drug applications from the Food and Drug Administration.

"While continual progress is being made, our focus is to ensure that this improvement is sustainable," Taro’s interim CEO Jim Kedrowski said. "Considerable effort will continue to be concentrated on improving our processes to deliver quality products on time and [to] build our pipeline, through [research and development], in order to meet the growing customer demand. As the Taro management team moves the company forward, the progress in our performance is expected to be consistent and gradual."

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PHARMACY

GDM risk can be assessed prior to pregnancy

BY Allison Cerra

OAKLAND, Calif. — A woman’s risk of developing a type of diabetes typically caused by pregnancy can be identified up to seven years prior to becoming pregnant, according to a new study by Kaiser Permanente.

The study, part of Kaiser Permanente’s ongoing research to understand, prevent and treat gestational diabetes mellitus, found that routinely assessing blood sugar and body weight measures can provide women with insight on their risk of developing GDM.

By examining data taken from 580 ethnically diverse women who took part in a multiphasic health checkup at Kaiser Permanente Northern California between 1984 and 1996, researchers at the Kaiser Permanente Division of Research found that the risk of GDM directly increased when a number of adverse risk factors commonly associated with diabetes and heart disease (i.e., high blood sugar, hypertension and being overweight) were present before pregnancy.

What’s more, the study authors found that adverse levels of blood sugar and body weight were associated with a 4.6 times increased risk of GDM, compared with women with normal levels.

"Our study indicates that a woman’s cardio-metabolic risk profile for factors routinely assessed at medical visits, such as blood sugar, high blood pressure, cholesterol and body weight, can help clinicians identify high-risk women to target for primary prevention or early management of GDM," said lead author Monique Hedderson, a research scientist at the Kaiser Permanente Division of Research.

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Sanofi: Lyxumia won’t significantly increase hypoglycemia risk

BY Alaric DeArment

PARIS — New results from a late-stage clinical trial of a Sanofi drug for Type 2 diabetes indicated that the drug can reduce blood sugar in patients without increasing the risk of causing the blood sugar levels to dip too low, the French drug maker said Tuesday.

Sanofi, which shortened its name earlier this month from Sanofi-Aventis, announced results of the phase-3 “GetGoal-L” trial of Lyxumia (lixisenatide), saying that when used as an add-on therapy with basal insulin and with or without metformin, the drug “significantly” reduced HbA1C levels, compared with placebo, without significantly increasing the risk of hypoglycemia. The trial, part of the broader “GetGoal” phase-3 study program, enrolled 495 patients who received either Lyxumia or placebo.

“These positive efficacy and safety results are another important milestone in the GetGoal clinical trial program and show the potential value of adding Lyxumia to basal insulin to improve glycemic control,” Sanofi global diabetes division SVP Pierre Chancel said. “The findings from this and previous studies reinforce the continuing positive trend demonstrating the potential of lixisenatide to improve the lives of people with Type 2 diabetes.”

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