Two cardiometabolic-related news items have been observed: Abbott announced the Libre 2 iOS app received FDA clearance and Ionis announced the pelacarsen CVOT, called Lp(a) HORIZON, has reached 50% enrollment. Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: Lexicon, Merck, and Intercept hosted their Q2 ’21 earnings calls and provided updates to their respective CV/Met businesses. Below, FENIX provides highlights and insights for the calls.
Dexcom hosted its Q2 ’21 earnings call and provided updates to its clinical and commercial activities, including the G7 OUS launch anticipated later in 2021. Below, FENIX provides highlights and insights from the call.
Two diabetes-related news items have been observed: Viatris and Biocon announced FDA approval of Semglee (bs-glargine) as the first interchangeable biosimilar insulin product under the 351(k) regulatory pathway; and Sanofi hosted its Q2 ’21 earnings call and provided a brief update to its diabetes business. Below, FENIX provides highlights and insights from the respective news items.
AstraZeneca hosted its Q2 ’21 earnings call, and once again, much of the prepared remarks and Q&A focused on the company’s COVID-19 vaccine development and oncology portfolio. Below, FENIX provides highlights and insights from the call.
A series of cardiometabolic-related new items have recently been observed: Lifescan and Noom announced an expanded partnership focused on Noom’s Diabetes Support Program; Supersapiens announced the addition of Howard Zisser and Robby Ketchell to the company’s executive team; Teladoc (press release; slides), Pfizer (press release; slides), and Teva (press release; slides) hosted their respective Q2 ’21 earnings calls. Below, FENIX provides highlights and insights for the respective news items.
AstraZeneca and Regeneron announced a collaboration for the research, development, and commercialization of small molecule compounds against the GPR75 gene to treat obesity and related comorbidities. For context, genetic mutations in GPR75 have been linked to patients having a lower BMI and experiencing a 54% lower risk of obesity than those without the mutation. According to the press release, AZ and Regeneron will evenly split the research and development costs as well as any future profits.
Bayer recently announced 10mg and 20mg finerenone, branded as “Kerendia,” received FDA approval. The approval of finerenone is based on the positive results of the FIDELIO-DKD study which demonstrated an 18% RRR in the primary composite endpoint. Below, FENIX has conducted a Kerendia label and website analysis.
A series of diabetes-related news items have recently been observed: AZ announced FDA approval of Bydureon BCise for patients 10-17 years of age with T2DM; Biocon hosted its FY Q1 ’22 (CY Q2 ’21) earnings call; and a CT.gov record has been observed for MannKind’s first Afrezza Ph3 pediatric study, called INHALE-1. Below, FENIX provides highlights and insights for the respective news items.
Abbott (press release; view infographic) and Roche (press release; slides) hosted their Q2 ’21 earnings calls and provided updates to their respective diabetes businesses and Adocia provided its Q2 ’21 financial update. Below, FENIX provides highlights and insights for the respective news items.