Sanofi (NYSE:SNY) said today that the European Commission granted marketing authorization in Europe for its Suliqua combination product for adults with type II diabetes. The therapy is a fixed-ratio combination of basal insulin glargine and lixisenatide, intended to be used with metformin to improve patients’ glycemic control. Suliqua will be available in 2 pre-filled SoloSTAR pens at […]
Diabetes
Selecting seals for new insulin delivery devices
High technical precision in insulin pump seals is important for ensuring that seals meet regulatory requirements and will be operationally sound. Drew Rogers, global director of healthcare & medical, Trelleborg Sealing Solutions With more than 400 million adults worldwide suffering from diabetes and 1.5 million deaths directly attributed to the disease each year, it’s no wonder […]
Nordisk takes a hit from Trump, lawsuit
Novo Nordisk (NYSE:NVO) shares fell more than 5% yesterday, following a lawsuit alleging that the Danish diabetes giant made misleading earning forecasts and comments from the President-elect regarding drug prices. The securities class action lawsuit against Nordisk also named Eli Lilly (NYSE:LLY), Sanofi (NYSE:SNY) and Merck (NYSE:MRK), claiming that Nordisk’s reported earnings and forecasts were inflated through price fixing for the company’s […]
Dexcom surges on Medicare nod for continuous glucose monitors
DexCom (NSDQ:DXCM) said yesterday that the Centers for Medicare & Medicaid classified therapeutic continuous glucose monitors as durable medical equipment under Medicare Part B. The company’s Dexcom G5 Mobile is the only CGM system that falls under this classification, according to San Diego, Calif.-based DexCom, since patients can make treatment decisions using the device. DXCM […]
Shire to pay feds $350m to settle Dermagraft kickbacks case
The U.S. Justice Dept. said yesterday that Shire (NSDQ:SHPG) and its subsidiaries will cough up $350 million to settle allegations that Shire and the company it acquired in 2011, Advanced BioHealing, gave kickbacks to clinics and physicians in exchange for using its bioengineered human skin substitute, Dermagraft. “This settlement represents the largest False Claims Act recovery by the […]
DexCom gains on Q4 prelims
DexCom Inc. (NSDQ:DXCM) posted its preliminary financial results for the 4th quarter, meeting analysts’ expectations on Wall Street and sending its shares upwards. The San Diego, Calif.-based company said it expects a total revenue of $168 million for Q4, a 28% increase from the same period in 2015, while analysts on The Street were looking for […]
Intarcia, Calibr collaborate to develop peptide therapeutic for Medici pump
Intarcia Therapeutics and the California Institute for Biomedical Research said today that the 2 groups will collaborate to develop a peptide therapeutic for patients with type II diabetes and obesity. The drug will be derived from Calibr’s stapled-peptide technology platform, combined with Intarcia’s late stage investigational GLP-1 therapy and delivered using the match-sized Medici osmotic […]
University of Virginia has a smartphone-controlled artificial pancreas
Danielle Kirsh, MDO Assistant Editor University of Virginia researchers are making strides when it comes to developing an artificial pancreas that can be controlled using a smartphone. The FDA approved the UVA-developed artificial pancreas for testing in 2012, and UVA received a $3.4M grant from the National Institutes of Health in 2013. The device is currently […]
Sanofi sues Nordisk over Tresiba marketing claims in U.S.
Sanofi (NYSE:SNY) said yesterday that it is suing competitor Novo Nordisk (NYSE:NVO) for “misleading” marketing materials that claim Sanofi’s insulin drugs Lantus and Toujeo will be “blocked” by U.S. pharmacy benefit manager CVS Caremark in January and that patients should switch to Nordisk’s Tresiba. CVS is replacing both Sanofi’s and Nordisk’s drugs with Eli Lilly’s Basaglar on […]
Fluor to build Novo Nordisk’s $2b manufacturing facility in North Carolina
Fluor Corporation (NYSE:FLR) said yesterday that it landed a contract to build Novo Nordisk‘s (NYSE:NVO) $2 billion diabetes active pharmaceutical ingredient manufacturing facility in Clayton, North Carolina. Since Denmark-based Novo Nordisk announced plans for the facility in August 2015, Fluor has been providing basic design services for the project. The manufacturing facility will measure 830,000 […]
