The FDA plans to review Sanofi‘s (NYSE:SNY) Dupixent monoclonal antibody as an add-on maintenance treatment in adults with moderate-to-severe asthma, according to the pharmaceutical company. The U.S. regulatory agency is slated to decide whether it will approve this new indication for Dupixent by Oct. 20. Sanofi’s drug, a subcutaneous injection delivered using a pre-filled syringe, […]
Sanofi touts real-world data for Toujeo insulin glargine injection
Sanofi (NYSE:SNY) touted data today from its 10,000-patient Lightning study, which evaluated electronic medical records of adults with Type II diabetes to study its long-acting insulin glargine injection, Toujeo. The company found that Toujeo significantly lowered patients’ risk of experiencing severe low blood sugar compared to other long-acting insulin, like its own Lantus product. The data, […]
Sales for Sanofi’s U.S. diabetes biz fall -30% in Q4
Shares in Sanofi (NYSE:SNY) fell today after the French pharmaceutical giant missed expectations on Wall Street with its 4th quarter and full-year financial results. The company faced particular challenges in its diabetes business, which saw its global sales plunge -14% in Q4. Revenues for Sanofi’s diabetes unit in the U.S. fell -29.5% compared to the same […]
Verily, Sanofi and other industry players team up with NIH to advance Parkinson’s therapies
The National Institutes of Health is joining forces with the tech and pharmaceutical industries to speed the development of new drugs for Parkinson’s disease and identify biomarkers for the debilitating condition. Companies participating in the public-private partnership include Celgene (NSDQ:CELG), GlaxoSmithKline (NYSE:GSK), The Michael J. Fox Foundation for Parkinson’s Research, Pfizer (NYSE:PFE), Sanofi (NYSE:SNY) and Verily. Combined the […]
Enteris touts Ph2 trial data for oral endometriosis therapy
Privately-held biotech Enteris BioPharma touted data today from a Phase IIa trial of its oral leuprolide formulation, Ovarest. The Boonton, N.J.-based company reported that its product triggered significant suppression of estradiol, which is correlated with efficacy in treating endometriosis. “The positive results from the Phase IIa clinical trial of Ovarest are a significant advancement towards Enteris’ […]
Study: Most commonly-prescribed diabetes drug linked to lowest rate of compliance
Patients who take the most-commonly prescribed diabetes medication, metformin, are the least likely to adhere to a prescribed regimen, according to a study published in the journal Diabetes, Obesity and Metabolism. Researchers from the University of Surrey looked at data from 1.6 million people with Type II diabetes across 48 trials and found that 30% of […]
Appeal board to review Sanofi’s Lantus insulin injection patents
The U.S. Patent and Trademark Appeal Board has instituted inter partes review on all claims against two patents owned by Sanofi (NYSE:SNY) for the company’s Lantus insulin glargine injection. Sanofi filed a patent infringement suit against Mylan (NSDQ:MYL) in October after the EpiPen-maker submitted an NDA for a pre-filled insulin glargine pen, challenging the patents listed for Sanofi’s Lantus […]
FDA approves Sanofi’s short-acting insulin lispro injection
The FDA today approved Sanofi‘s (NYSE:SNY) Admelog insulin lispro injection. The product is indicated to help adults and kids with Type I and Type II diabetes control their blood sugar levels. Admelog is the first short-acting insulin approved using the FDA’s 505(b)(2) pathway. “One of my key policy efforts is increasing competition in the market […]
Sanofi touts head-to-head comparison of long-acting insulin products
Sanofi‘s (NYSE:SNY) long-acting insulin glargine, Toujeo, met the primary objective of a head-to-head trial comparing it to Novo Nordisk‘s (NYSE:NVO) insulin degludec, Tresiba, the company reported today. The insulin-maker said it plans to report full results from the Bright trial sometime next year. The study’s primary objective was to determine if Toujeo had a similar […]
Onduo taps Glytec’s insulin therapy software as part of virtual diabetes clinic
Glytec has inked a deal with Onduo to integrate the company’s Glucommander Outpatient insulin management software into Onduo’s virtual diabetes clinic. Onduo, a joint venture of Sanofi (NYSE:SNY) and Verily, is reportedly working to develop a platform that brings together medical devices, software and support from healthcare experts to help people manage their Type II diabetes. The […]
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