HEALTH

Valeant completes iNova acquisition

BY Allison Cerra

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals officially owns an Australian drug maker.

The company announced that it completed its acquisition of iNova, which sells and distributes prescription and over-the-counter drugs in Australia, New Zealand, Southeast Asia and South Africa, on Dec. 21 from iNova’s current shareholders, Archer Capital, Ironbridge and others.

The deal, which was announced back in November, was valued at up to A$700 million.


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Webinar: CRN, VIRGO to bridge GMP gap between industry action and FDA expectations

BY Michael Johnsen

WASHINGTON — The Council for Responsible Nutrition and VIRGO on Tuesday announced details for an industrywide webinar to examine key elements of good manufacturing practices for dietary supplements and offer advice as to what the industry can do to improve its record of inspections. 

Moderated by Duffy MacKay, CRN VP scientific and regulatory affairs, the webinar will help companies better understand the intricacies of GMPs and will offer tips and best practices for passing Food and Drug Administration inspections.

In addition to MacKay, the panel will include as-yet-not-announced Food and Drug Administration representatives and other regulatory experts, such as Joy Joseph, president of Joys Quality Management Systems, and Nicki Jacobs, president of Jacobs Compliance Services.  These experts will review several key GMP requirements where inspections have demonstrated patterns of deficiency, such as the requirements to establish specifications for raw ingredients, test incoming ingredients, verify contents of finished products and follow master manufacturing. In addition, speakers will touch upon other often overlooked GMP provisions, such as the “umbrella” clauses that are requirements that apply to all the points on the supply chain, including manufacturers, suppliers, transporters and distributors.

“In the three-and-a-half years since the current GMP final rule first went into effect, there has been a disconnect between what companies are doing and what the FDA expects," MacKay said. "The problems are not limited to one size or type of company but have been seen across the board and are, quite frankly, disturbing. Ultimately, unless the industry improves its track record, our industry’s credibility will suffer.”

The webinar will be held Jan. 18. 


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Study: High blood pressure in middle age fair predictor of heart attack, stroke

BY Michael Johnsen

CHICAGO — A hike in blood pressure during middle age significantly raises the risk of having a heart attack or a stroke, according to new Northwestern Medicine research released Monday. The study offers a new understanding on the importance of maintaining low blood pressure early in middle age to prevent heart disease later in life.

Men and women who developed high blood pressure in middle age or who started out with high blood pressure had an estimated 30% increased risk of having a heart attack or stroke compared to those who kept their blood pressure low. Previous estimates of a person’s risk of cardiovascular disease were based on a single blood pressure measurement. The higher the blood pressure reading, the greater the risk. The new Northwestern Medicine study expanded on that by showing a more accurate predictor is a change in blood pressure from age 41 to 55 years.

"We found the longer we can prevent hypertension or postpone it, the lower the risk for cardiovascular disease," stated lead author Norrina Allen, assistant professor of preventive medicine at Northwestern University Feinberg School of Medicine. "Even for people with normal blood pressure, we want to make sure they keep it at that level, and it doesn’t start increasing over time."

"There hasn’t been as much of a focus on keeping it low when people are in their 40s and 50s," Allen added. "That’s before a lot of people start focusing on cardiovascular disease risk factors. We’ve shown it’s vital to start early."

People that maintain or reduce their blood pressure to normal levels by the age of 55 years have the lowest lifetime risk for a heart attack or a stroke.

The study used data from 61,585 participants in the Cardiovascular Lifetime Risk Pooling Project. Starting with baseline blood pressure readings at age 41, researchers measured blood pressure again at age 55, then followed the patients until the occurrence of a first heart attack or stroke, death or age 95.

Men who developed high blood pressure in middle age or who started out with high blood pressure had a 70% risk of having a heart attack or stroke compared to a 41% risk for men who maintained low blood pressure or whose blood pressure decreased during the time period. Women who developed high blood pressure had almost a 50% risk of a heart attack or stroke compared to a 22% risk for those who kept their blood pressure low or saw a decrease.

Men generally have a 55% risk of cardiovascular disease in their lifetimes; women have a 40% risk.

The study is published in Circulation: Journal of the American Heart Association.


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