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Lilly diabetes drug wins backing from EU regulator

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A European Medicines Agency panel recommended approving a diabetes drug from Boehringer Ingelheim GmbH and Eli Lilly and Co. that was rejected this month in the United States because of manufacturing deficiencies.

The medicine, Jardiance, should be approved as a treatment for type 2 diabetes, the agency’s Committee for Medicinal Products for Human Use said in a prepared statement Friday. The European Commission usually follows the panel’s advice.

Indianapolis-based Lilly is expected to garner $518 million in annual sales from Jardiance by 2019, according to the average of five analyst estimates compiled by Bloomberg.

The Food and Drug Administration said this month it wouldn’t approve the drug until Boehringer fixes the problems disclosed in May after a 2012 inspection of a plant in Ingelheim am Rhein, Germany, where the closely held company is based. The FDA completed its re-inspection of Boehringer’s plant March 7, the company said.

The treatment, also known as empagliflozin, is part of a class of medicines that includes Johnson & Johnson’s Invokana and AstraZeneca Plc’s Forxiga. The drugs help the body get rid of sugar through the kidneys. Type 2 diabetes, the most common kind, is often driven by obesity, as the body loses its ability to process sugar. The disease may be the seventh leading cause of death in the world by 2030, according to the World Health Organization.

 

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  1. In reality, Lilly is maintaining profit by cutting costs such as Indiana/US citizen IT workers by a significant amount with their Tata Indian consulting connection, increasing Indian H1B's at Lillys Indiana locations significantly and offshoring to India high paying Indiana jobs to cut costs and increase profit at the expense of U.S. workers.

  2. I think perhaps there is legal precedence here in that the laws were intended for family farms, not pig processing plants on a huge scale. There has to be a way to squash this judges judgment and overrule her dumb judgement. Perhaps she should be required to live in one of those neighbors houses for a month next to the farm to see how she likes it. She is there to protect the people, not the corporations.

  3. http://www.omafra.gov.on.ca/english/engineer/facts/03-111.htm Corporate farms are not farms, they are indeed factories on a huge scale. The amount of waste and unhealthy smells are environmentally unsafe. If they want to do this, they should be forced to buy a boundary around their farm at a premium price to the homeowners and landowners that have to eat, sleep, and live in a cesspool of pig smells. Imagine living in a house that smells like a restroom all the time. Does the state really believe they should take the side of these corporate farms and not protect Indiana citizens. Perhaps justifiable they should force all the management of the farms to live on the farm itself and not live probably far away from there. Would be interesting to investigate the housing locations of those working at and managing the corporate farms.

  4. downtown in the same area as O'malia's. 350 E New York. Not sure that another one could survive. I agree a Target is needed d'town. Downtown Philly even had a 3 story Kmart for its downtown residents.

  5. Indy-area residents... most of you have no idea how AMAZING Aurelio's is. South of Chicago was a cool pizza place... but it pales in comparison to the heavenly thin crust Aurelio's pizza. Their deep dish is pretty good too. My waistline is expanding just thinking about this!

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