FDA panel recommends approval for two Novo Nordisk insulin products
BAGSVÆRD, Denmark — A Food and Drug Administration panel has voted to support two experimental insulin treatments made by Novo Nordisk, the Danish drug maker said Thursday.
Novo Nordisk said the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee had voted 8-to-4 in favor of approval for insulin degludec and a combination treatment containing insulin degludec and insulin aspart.
The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them. However, the panel also voted unanimously to recommend that after approval, a post-marketing trial be conducted on the drugs to assess their effects on cardiovascular health.
"The positive vote from the advisory committee marks an important step towards making insulin degludec and insulin degludec-insulin aspart available to patients with diabetes in the US," Novo Nordisk EVP and chief science officer Mads Krogsgaard Thomsen said. "We look forward to completing the regulatory process with the agency, including the design of the post-approval cardiovascular outcomes trial."
Allscripts hints at possible acquisition
CHICAGO — Electronic health record firm Allscripts may be looking at buyout offers from other companies, Allscripts CEO Glen Tullman said Thursday when the company announced its third-quarter 2012 earnings.
"We are confirming today that in light of the ongoing interest expressed in the company by third parties, the company is evaluating strategic alternatives," Tullman said. "Regardless of the outcome of this process, Allscripts’ primary focus is and will continue to be serving our clients through our industry-leading technology, services and the support we provide to 1,500 hospitals and over 50,000 ambulatory physician practices and post-acute providers with whom we do business."
The company said there was "no assurance" that it would be acquired and that it did not intent to comment further publicly.
The company reported sales of $360.7 million, down from $363.7 million in third-quarter 2011, and profits of $9.4 million, down from $19.1 million a year ago.
Diplomat Specialty Pharmacy to hire 100 new employees
FLINT, Mich. — A rapidly growing specialty pharmacy company in Michigan is about to experience another spurt.
Diplomat Specialty Pharmacy said it had an immediate need to fill 100 full-time jobs, primarily in patient care coordination, order entry and customer service, but including 10 to 15 positions in areas like nursing, five in sales and account management, and 10 to 15 in technology areas like programming, quality analysis, data modeling and data architecture.
"Diplomat is already well known in Flint and Genesee County, and we have had great success in hiring from this area," Diplomat human resources manager Tracey Watlington said.
In April 2010, the company announced that it would purchase its new headquarters, the former General Motors Great Lakes Technology Centre complex in Flint, Mich., with plans to hire 1,000 workers over five years.
A big plan the company has is to help reinvent the city of Flint, historically an auto industry manufacturing center that has long suffered from economic depression. In August, the company hired Flint native Steve Wolbert to be its first community relations liaison, a position that the company said was so successful that it promoted him to director of government relations and community affairs.
"One of Diplomat’s strategic goals is to go beyond checkbook philanthropy to expand our corporate citizenship initiatives, provide opportunities for jobs and create a strong community fabric again," CEO and co-founder Phil Hagerman said. "Steve has deep ties to the local community and has already spearheaded projects since joining us in August that are putting Diplomat in a leadership role in the transformation of Flint and Genesee County."