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Approval is the first under firms’ global diabetes alliance for late-stage product development. FDA has approved Boehringer Ingelheim and Eli Lilly’s linagliptin tablets for the treatment of type 2 diabetes alongside diet and exercise measures. The firms’ diabetes alliance is focused on developing and commercializing a portfolio of diabetes compounds currently in mid- and late-stage development. Boehringer Ingelheim’s BI10773 is a sodium-dependent glucose co-transporter-2 (SGLT-2) inhibitor, which started in Phase III clinical trials in 2010.
Join 110,000 colleagues who rely on GEN Highlights for breaking news and exclusive articles shaping today’s life science tools and technologies. MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Approval covers use of the once-daily dipeptidyl peptidase-4 inhibitor either as monotherapy or in combination with other type 2 diabetes drugs including metformin, sulphonylurea, and pioglitazone, for reducing HbA1c levels.


Lilly will be eligible to receive up to a total of $650 million in success-based regulatory milestones on its two basal insulin analogues. Lilly’s two basal insulin analogue candidates are expected to enter Phase III clinical testing in 2011. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.Do you agree that ecstasy should be studied for its potential therapeutic benefits? If your item does not qualify for free shipping, you can still get fast and reliable shipping for a flat rate of $6.95 (Continent US). Three placebo-controlled studies evaluated linagliptin either as monotherapy or in combination with oral metformin and sulphonylurea in patients whose blood sugar was not adequately controlled on either of the latter two drugs.
The deal also includes an option to co-develop and co-commercialize Lilly’s Phase II-stage anti-TGF-beta monoclonal antibody. If Boehringer Ingelheim decides to opt-in to Phase III development and potential commercialization of the anti-TGF-beta monoclonal antibody, Lilly would be eligible for up to $525 million in opt-in and success-based regulatory milestone payments.


LY2605541 is a structurally novel basal insulin analogue, and LY2963016 is a new insulin glargine product. The studies confirmed linagliptin significantly reduced HbA1c levels when used as monotherapy and when added to the existing diabetes treatments.
A fourth study confirmed that adding linagliptin to pioglitazone therapy reduced HbA1c levels to a greater extent than pioglitazone monotherapy.



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