Biocon has reported that FDA issued a form 483 with six observations for its Malaysian facility. Recall, this facility is primarily responsible for the manufacturing of insulins including its biosimilar glargine. Biocon did not provide further details into the FDA observations.
Biocon hosted its CY Q4 ’17 (FY Q3 ’18) earnings call and provided updates on its insulin portfolio including bs-glargine regulatory status, bs-aspart Ph1 initiation, and Tregopil (oral insulin) Ph2/3 initiation in India. Below are highlights from the call.
Sanofi has reportedly announced a round of 400 layoffs for the diabetes and cardiovascular business unit sales team. In a separate news release, it was also announced that Sanofi has appointed Dominique Carouge, former VP of Administration & Management for Global R&D, as a new EVP Head of Business Transformation.
Lilly disclosed major announcements about its diabetes connected care strategy, including intentions to develop an in-house automated insulin-delivery (AID) device as well as a wireless smart pen injection device. As a part of this endeavor, Lilly has engaged in collaborations with Deka R&D Corp., CGM-manufacturer Dexcom, and acquired Montreal-based algorithm startup Class AP. In light of these developments, Lilly has indicated plans to initiate trials by YE 2017 and has suggested it will take 2-3 years for these new devices to reach the market.
On May 10th, Mylan hosted its Q1 2017 earnings call and briefly discussed its insulin glargine development program.
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.
Mylan hosted its Q4 and full-year 2016 earnings call in conjunction with its investor day and provided an update to the insulin pipeline.