Tag Archives: lannett

Insulet, Mannkind, and Lannett Q3 ’20 Earnings Updates

Insulet (press release), Mannkind (press release), and Lannett (press release) hosted their respective Q3 ’20 earnings calls. Of note, Insulet provided updates to its Omnipod 5 development plans, including the recent initiation of a T2DM feasibility study. Furthermore, following a meeting between Lannett and FDA in June 2020, Lannett said it is finalizing the trial protocol evaluating its bs-glargine in healthy volunteers. Below, FENIX provides highlights and insights from the calls.

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Lannett To Forego Bs-Glargine U100 Interchangeability; Lannett Q2 ’20 Earnings Update

Yesterday, Lannett (press release) hosted its CY Q2 ’20 (FY Q4 ’20) earnings call and provided updates to its biosimilar glargine U100 development and regulatory plans. Importantly, Lannett disclosed that its bs-glargine U100 strategy is to forego interchangeability and compete as an “affordable alternative.” Below, FENIX provides highlights and insights from the call, including thoughts on Lannett’s strategy as the 5th-to-market bs-glargine U100 in the US.

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Livongo, MannKind, and Lannett Q1 ’20 Earnings Updates; Senseonics Receives Positive BCBS Coverage Decisions

Livongo, MannKind, and Lannett each hosted their Q1 ’20 earnings call and provided updates to their respective businesses. Senseonics also announced positive coverage decisions from three BCBS plans. Importantly, Lannett said it believes it can file their bs-glargine with FDA as early as 2022. Below, FENIX provides highlights and insights from the calls.

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Lannett Bs-glargine Regulatory Update

Lannett announced it has a Biosimilar Biological Product Development Type II meeting scheduled with FDA on June 9 to discuss the next steps in the clinical advancement of its biosimilar glargine. Lannett is developing the bs-glargine in partnership with YiChang HEC ChangJiang Pharmaceutical Co. (HEC Pharm). Below, FENIX provides insights on the Lannett development program in the context of the recent insulin conversion from a drug to a biologic as well as the November 2019 immunogenicity draft guidance.

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Positive Lannett Bs-Glargine Ph1 Results; Zealand Initiates 2nd Ph3 CHI Study

Lannett has announced positive results from the Ph1 PK/PD study evaluating their biosimilar insulin glargine vs. Lantus, which initiated in June 2019. In light of meeting all primary endpoints, Lannett indicated they are planning to meet with FDA to discuss the next steps for bs-glargine development. Below, FENIX provides context and insights, particularly related to the FDA’s recent biosimilar insulin draft guidance.

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