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Study: Insulin degludec reduces risk of nocturnal hypoglycemia among Type 2 diabetes patients

BY Allison Cerra

PHILADELPHIA — An investigational insulin being developed by Novo Nordisk significantly reduced the rate of hypoglycemia at night in adults with Type 2 diabetes, according to results of a late-stage clinical trial presented at the 72nd Scientific Sessions of the American Diabetes Association.

Novo Nordisk said during a 52-week randomized, open-label, noninferiority, treat-to-target trial, its ultra long-acting insulin degludec reduced the rate of nocturnal hypoglycemia while obtaining equivalent improvement in glucose control, compared with insulin glargine. Both insulins were given once-daily in 1,030 insulin-naïve Type 2 diabetes adults inadequately controlled with oral antidiabetic medications.

Insulin degludec was submitted for once-daily use to the Food and Drug Administration in September 2011 for regulatory review.

"Nocturnal, or night-time, hypoglycemia is a particular challenge for people living with diabetes, as these episodes are often unpredictable and difficult to detect," said Bernard Zinman, lead author and director of the diabetes center at Mount Sinai Hospital, and professor of medicine at the University of Toronto. "This study demonstrated that treatment with insulin degludec significantly reduced the rate of nocturnal hypoglycemia."


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N.Y. governor seeks to curb Rx drug abuse with new legislation

BY Allison Cerra

ALBANY, N.Y. — The state of New York is looking to become a national leader in curbing prescription drug abuse.

Governor Andrew Cuomo, along with attorney general Eric Schneiderman, Senate majority leader Dean Skelos and assembly speaker Sheldon Silver, introduced new legislation that will include a series of provisions that are designed to overhaul the way prescription drugs are distributed and tracked in New York. The governor’s legislation creates an all-electronic online registry — which is being heralded as the first in the nation — to enable doctors, pharmacists and law enforcement to track controlled substances in real time and prevent excessive prescription and refill requests. What’s more, this legislation also includes a disposal program to encourage New Yorkers to safely dispose of unused prescription drugs, as well as increase education for healthcare providers about the potential for abuse of controlled substances and the proper balancing of pain management with abuse prevention.

Additional details may be found here.

"This landmark agreement will help put a stop to the growing number of fatalities resulting from overdoses on prescription drugs," Cuomo said. "We have seen too many untimely deaths as a result of prescription drug abuse, and today New York State is taking the lead in saying enough is enough. I commend attorney general Schneiderman, majority leader Skelos, and speaker Silver for their hard work in putting together this groundbreaking reform package that will help protect New Yorkers and put an end to prescription drug abuse."


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Once again, Human Genome Sciences rejects GSK’s bid

BY Allison Cerra

ROCKVILLE, Md. — GlaxoSmithKline again has extended an unsolicited tender offer to acquire Human Genome Sciences.

HGS, which previously rejected an unsolicited bid from GSK, said the latest bid, which was extended Friday, is a tender offer to acquire all of the outstanding shares of HGS for $13 per share. HGS said that the offer price is inadequate and "does not reflect the value inherent in [the company]."

"As previously announced, our board has authorized the exploration of strategic alternatives in the best interests of stockholders, including a potential sale of the company. This process continues to be active and fully underway," HGS said. "GSK declined to enter the process and, through its unsolicited tender offer, seeks to circumvent, disrupt and prematurely end the Company’s process to the disadvantage of HGS stockholders. We are committed to completing our exploration of strategic alternatives as expeditiously as possible, and the HGS board of directors recommends that HGS stockholders reject GSK’s tender offer and not tender any of their shares to GSK."

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