Both Novo Nordisk (NYSE:NVO) and Sanofi (NYSE:SNY) said yesterday that they won FDA approval for pre-filled pens with drug combinations indicated for adults with Type II diabetes. Paris-based Sanofi’s Soliqua 100/33 is an injectable medicine composed of 2 diabetes drugs – insulin glargine and lixisenatide. The drug is approved for adults with Type II diabetes not controlled with less than […]
Sanofi-Aventis
Novo Nordisk shares dive after long-term growth cut
(Reuters) — Top insulin maker Novo Nordisk (NYSE:NVO) slashed its long-term profit growth forecast today, signaling no let-up in its struggles to crack the U.S. market to which its chief executive said its commitment would not waver. The Danish firm’s shares fell by as much as 19% to a 30-month low, wiping more than $15 billion off […]
Kaléo plans 2017 U.S. relaunch for EpiPen comptetitor Auvi-Q
Kaléo Inc. said on Wednesday that it will relaunch its Auvi-Q injector for emergency allergy treatment in the 1st half of 2017 in the U.S., according to Reuters. The Richmond, Virginia-based company’s device was recalled last year after concerns about the accuracy of delivered dose. Sanofi (NYSE:SNY) made and licensed the Auvi-Q device from Kaléo, but returned […]
Sanofi sues Merck over injected insulin
Sanofi Aventis (NYSE:SNY) said today that it filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. (NYSE:MRK) over 10 U.S. patents related to its injected insulin device. The Paris-based company said it is seeking an injunction and damages from Merck for filing a new drug application with the FDA that challenged 10 of Sanofi’s […]
Sanofi, Google’s Verily launch $500m Onduo diabetes JV
Sanofi (NYSE:SNY) and Verily Life Sciences, the healthcare play owned by Google parent Alphabet (NSDQ:GOOGL), are launching a joint venture to tackle diabetes. The Cambridge, Mass.-based Onduo JV will aim to combine Verily’s expertise in miniaturized electronics, analytics, and consumer software with Sanofi’s diabetes program. Dr. Joshua Riff, formerly senior vice president of prevention & wellbeing at UnitedHealth‘s (NYSE:UNH) Optum business, was tapped to be […]
FDA request delays timeline for Sanofi’s iGlarLixi drug-device combo for diabetes
By Sarah Faulkner The FDA’s request for more data on the iGlarLixi drug-device combination for treating Type II diabetes pushed the timeline for a decision back 3 months, Sanofi (NYSE:SNY) and Zealand Pharma (CPH:ZEAL) said last week. Sanofi said August 19 that it submitted a new data package for iGlarLixi, an injection pen designed to […]
Mannkind taps medtech reps after Sanofi deal fails
Mannkind chief commercial officer Michael Castagna is trying to resuscitate the inhaled insulin maker after its co-marketing agreement with Sanofi (NYSE:SNY) was cancelled at the beginning of the year due to disappointing sales. He’s fielding a team of about 70 people to sell the company’s Afrezza insulin inhaler, with about ⅓ coming from the medical […]
Google, Sanofi team up to improve diabetes care
(Reuters) — Google Inc and French drugmaker Sanofi SA said they will partner to develop tools to improve the management and treatment of diabetes. Sanofi will work with Google’s life sciences team to collect, analyze and understand information impacting diabetes, which is expected to affect 592 million by 2035, according to the International Diabetes Federation. Sanofi’s […]
Sanofi’s Genzyme pays $33m, enters DPA in criminal Seprafilm case
(Reuters) — Genzyme agreed to pay $32.59 million, admit wrongdoing and enter a deferred prosecution agreement to resolve criminal charges over its marketing of the surgical implant Seprafilm, the U.S. Justice Dept. said yesterday. The biotechnology unit of French drug company Sanofi (NYSE:SNY) was accused of 2 misdemeanor counts of violating the federal Food, Drug and Cosmetic Act from […]
Sanofi announces reorganization ahead of strategic plan
(Reuters) – Sanofi will adopt a simplified structure centered around five global business units starting in January 2016 to promote growth, the French drugmaker said on Wednesday, as it prepares a new strategic plan to be unveiled in November. The company said the 5 would be: general medicines & emerging markets, specialty care, diabetes & cardiovascular, […]
Public Citizen pushes FDA to recall Sanofi’s Seprafilm
(Reuters) — Consumer watchdog Public Citizen said it petitioned the FDA to withdraw approval of Sanofi‘s (NYSE:SNY) Seprafilm and order a recall, saying the surgical implant has been associated with side effects including death. Seprafilm, developed by Sanofi subsidiary Genzyme, is used to reduce abnormal internal scarring following surgery, by separating tissues and organs while they […]