PHARMACY

Novo Nordisk set to develop oral insulin

BY Allison Cerra

NEW YORK Novo Nordisk is set to make an oral insulin for diabetic patients, the drug maker announced at the Reuters Health Summit.

Speaking at the Reuters Health Summit, Lars Sorensen, Novo’s CEO, called an oral insulin product “a potential game-changer.”

“We have seen some interesting leads that makes us believe it might be feasible,” Sorensen said at the conference. “We have the first product candidates going into human clinical trials as we speak, but it is a very complex issue because proteins need to be changed to be more acid stable.”

Sorensen also said at the conference that the company would most likely market an oral therapy to treat diabetes within the next six years.

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FDA approves generic gastroesophageal reflux disease treatments

BY Alaric DeArment

PITTSBURGH The Food and Drug Administration has given two companies approval for a generic version of a drug used to treat gastroesophageal reflux disease.

Teva Pharmaceutical Industries and Matrix Labs – the Indian subsidiary of U.S. drug maker Mylan – received approval for manufacturing lansoprazole delayed-release capsules. The drug is a generic version of Tap Pharmaceuticals’ Prevacid DR, which had sales of $2.97 billion during the 12-month period ended June 30, according to IMS Health data.

Both companies said they would begin shipping their versions of the drug immediately. The Matrix version will be sold under the Mylan Pharmaceuticals brand.

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FDA approves GSK’s nonadjuvant H1N1 vaccine

BY Alaric DeArment

PHILADELPHIA GlaxoSmithKline on Tuesday announced that the Food and Drug Administration has approved its unadjuvanted influenza A(H1N1) pandemic vaccine.

The U.S. Department of Health and Human Services has placed an order to fill 7.6 million doses of unadjuvanted H1N1 pandemic vaccine from GSK, which will contribute to the approximately 250 million doses secured by the U.S. government.  The vaccine will be produced in multi-dose vials from bulk vaccine manufactured at GSK’s facility in Quebec, Canada.  GSK expects to begin shipping vaccine in December and to provide all 7.6 million doses by the end of the year.

An adjuvant is a substance added to a vaccine to improve the immune response, however none of the H1N1 vaccines currently approved in the U.S. contain adjuvants.

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