Merck has announced it received a complete response letter (CRL) regarding its submission of data from the TECOS cardiovascular outcomes trial for Januvia (sitagliptin). The company has not disclosed the reason for the CRL, but said it is working with FDA to discuss next steps.
Lilly has announced intentions to invest $850M in its US operations in 2017 including $85M to expand the Trulicity device assembly operations. Additionally, Lilly announced the dedication of a $140M insulin cartridge facility.
Lilly and the William Sansum Diabetes Center in Santa Barbara, California have entered into a research collaboration to further understand the unmet needs related to diabetes in the Latino population.
In an effort to increase diabetes awareness, MannKind and Bella & Elle Media LLC are collaborating on “Reversed,” a “Diabetes Reality TV Show” to air on Discovery Life Channel in the summer of 2017.
Lexicon hosted its Q4 and full-year 2016 earnings call and provided an update to its diabetes pipeline.
Mylan hosted its Q4 and full-year 2016 earnings call in conjunction with its investor day and provided an update to the insulin pipeline.
Merck/Pfizer quietly filed their SGLT2i, ertugliflozin, FDC with metformin, and FDC with Januvia (sitagliptin) in December 2016.
Lexicon recently presented at the Leerink Global Healthcare Conference and provided updates to its diabetes development programs.
EMA has issued a warning that Invokana is associated with increased cases of lower limb amputations, particularly toes, in the CANVAS and CANVAS-R studies. The underlying cause remains unknown. While EMA has concluded the risk exists, the issue remains under investigation with FDA.
Merck hosted their Q4 and full-year 2016 earnings update today. Overall, there was minimal diabetes-related discussion as the primary focus was on Keytruda.