ADA 2019 Abstract and Session Titles Available
ADA 2019 abstract and session titles are available through the ADA desktop app. According to the ADA website, full abstract text will be available Tuesday, June 4 at 5:00 pm ET.
ADA 2019 abstract and session titles are available through the ADA desktop app. According to the ADA website, full abstract text will be available Tuesday, June 4 at 5:00 pm ET.
MannKind and Mylan both hosted their respective Q1 ’19 earnings calls. Of note, Mylan did not discuss its biosimilar insulin programs (including bs-glargine) or bs-glucagon. Below, FENIX provides highlights and insights from the MannKind earnings call.
Lilly hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for “technical reasons,” and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 ’19 regulatory events in diabetes.
Biocon hosted its CY Q1 ’19 (FY Q4 ’19) earnings call and briefly discussed its biosimilar insulin program including bs-glargine and bs-aspart. Below, FENIX provides highlights and insights from the call.
Express Scripts has excluded Lilly’s lispro authorized generic (AG) from its 2019 National Preferred Formulary. The exclusion takes effect starting July 1, 2019. Recall, on March 4, 2019, Lilly announced its intention to launch the lispro AG at a 50% WAC discount. Below, FENIX provides brief thoughts on ESI’s exclusion decision.
Sanofi hosted its Q1 ’19 earnings call but only briefly discussed its diabetes business including the recent sotagliflozin T1DM CRL. Below, FENIX provides highlights and insights from the call.
Sanofi announced that it has increased the benefits to its Valyou insulin savings program to now offer up to 10 boxes of SoloStar insulin pens and/or 10 vials of 10mL insulin for $99 per month. Previously each 10 mL vial was $99 and each box of SoloStar pens was $149. According to the press release, the program covers all Sanofi insulins (Lantus, Toujeo, Admelog, and Apidra) but not Soliqua. The program will become available starting in June 2019. Below, FENIX provides brief thoughts on the program in the context of the ongoing drug pricing debate.
Today, the Senate Finance Committee held its third hearing on drug pricing titled “Drug Pricing in America: A Prescription for Change, Part III” which focused particularly on the role of PBMs. As predicted, the PBMs largely tried to deflect attention back onto pharmaceutical manufacturers. Key themes from the hearing include: 1) PBMs blame outdated MPD legislation, PBMs do not set list prices, and PBMs do not want to provide as much transparency as manufacturers do. Below, FENIX provides highlights and insights from the hearing.
Sanofi has initiated a new Ph1 trial evaluating a U200 concentration of its bs-lispro. Below, FENIX provides thoughts on why Sanofi is pursuing U200 Admelog including its likely use in the pre-filled patch pump that is being developed in partnership with Verily and Sensile Medical.
Sanofi is reportedly set to lay off an undisclosed number of diabetes US sales reps starting in June 2019. Below, FENIX provides thoughts on the new layoffs in the context of increasing US pricing pressures on Sanofi’s insulin franchise as well as the recent sotagliflozin CRL.