Democrats from the House Committee on Oversight and Government Reform have sent letters to seven drugmakers as part of an investigation into why prices for multiple sclerosis drugs have nearly quadrupled since 2004. Reps. Elijah Cummings (D-Md.) and Peter Welch (D.-Mass) penned inquiries to Bayer (ETR:BAYN), Biogen (NSDQ:BIIB), EMD Serono, Novartis (NYSE:NVS), Roche (OTC:RHHBY), Sanofi Aventis (NYSE:SNY) and Teva Pharmaceuticals (NYSE:TEVA). […]
Sanofi-Aventis
Mylan inks $465m settlement with DOJ over EpiPen Medicaid classification
Mylan (NSDQ:MYL) said today that it inked a $465 million deal with U.S. Dept. of Justice to settle claims that it misclassified its EpiPen allergy auto-injector device with the Medicaid Drug Rebate Program. In October last year, The Centers for Medicare & Medicaid Services said that Mylan had been overcharging Medicaid for its EpiPen device for years, […]
Sanofi brings another insulin glargine patent suit against Merck
Sanofi Aventis (NYSE:SNY) yesterday filed another patent lawsuit against Merck Sharp & Dohme Corp. (NYSE:MRK), alleging that Merck’s product infringes upon two patents covering Sanofi’s insulin glargine product, Lantus. In July, Merck won tentative approval for its follow-on biologic version of Sanofi’s Lantus. The agency’s final regulatory nod is contingent upon the resolution of these patent infringement […]
AntriaBio launches trial of once-weekly insulin
AntriaBio (OTC:ANTB) said today that the first patient was dosed in a Phase I first-in-human trial of its once-weekly basal insulin. The single ascending dose study is designed to test the safety, pharmacokinetics and dynamics of AB101 in patients with Type I diabetes. The second part of the study is slated to compare AB101 to Sanofi‘s […]
Lawsuit stalls approval of Merck’s insulin injection
Merck (NYSE:MRK) said today that the FDA granted tentative approval for its Lusduna Nexvue insulin glargine injection. The biologic basal insulin met regulatory standards, the company said, but a patent infringement lawsuit initiated by competitor Sanofi (NYSE:SNY) in September of last year invoked an automatic delay for the drug-device combination product’s final approval. The stay could last […]
Voluntis wins regulatory nod to integrate Toujeo insulin with Insulia mobile app
Voluntis said today its digital management system for people with Type II diabetes, Insulia, won FDA clearance and CE Mark approval to integrate Sanofi‘s (NYSE:SNY) Toujeo insulin glargine. The company’s software already works with Lantus and Levemir. The Insulia digital companion is composed of a patient mobile app and healthcare worker web portal. The app […]
Judge rules that Mylan can’t move EpiPen antitrust suit
New Jersey federal judge Freda Wolfson rejected Mylan‘s (NSDQ:MYL) request to move an antitrust lawsuit brought against the EpiPen maker to Kansas. Mylan previously claimed that moving the case to Kansas would consolidate it with other class actions from EpiPen buyers – all of which are alleging violations of antitrust laws. Wolfson blocked the request […]
Mylan shareholders vote against executive pay package, but re-elect board
At the company’s annual meeting, Mylan (NSDQ:MYL) shareholders re-elected the drugmaker’s board despite a campaign spearheaded by major investors to do otherwise. The campaign hoped to encourage shareholders to vote down most of the board’s directors in response to Mylan’s drug pricing practices for its EpiPen device. The influential proxy advisory firm, ISS, also urged shareholders […]
Sanofi, Parexel collaborate on clinical trial data collection wearables
Parexel said today it is collaborating with Sanofi (NYSE:SNY) to develop and promote wearable devices to improve collection of data during clinical trials. Through the collaborative deal, the 2 companies will leverage their specific expertise to explore how wearables could improve study performance and new drug development and how sensors from several wearable devices could be […]
Braeburn names former Teva exec as new president, CEO | Personnel Moves – June 14, 2017
Braeburn Pharmaceuticals said last week that it named Michael Derkacz as president and CEO of the buprenorphine implant-maker. Most recently, Derkacz worked as senior VP and head of global central nervous system and pain therapeutic areas for Teva Pharmaceuticals (NYSE:TEVA). Behshad Sheldon, who helped to found Braeburn in 2012, is slated to step down from Braeburn […]
