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News Breaks
December 11, 2013
05:41 EDTSNYFDA grants priority review for Genzyme's Cerdelga
Genzyme, a Sanofi company, announced that the FDA has granted a six-month Priority Review designation to its New Drug Application for Cerdelga, an investigational oral therapy for adult patients with Gaucher disease type 1. As previously announced, the European Medicines Agency in late October validated Genzyme’s marketing authorization application for eliglustat in the EU. Genzyme is developing eliglustat, a capsule to be taken twice daily, to provide an effective oral treatment alternative for adult patients with Gaucher disease type 1, and to provide a broader range of treatment options for Gaucher patients and physicians. Genzyme’s clinical development program for eliglustat represents the largest clinical program ever conducted in Gaucher disease, with approximately 400 patients treated in 29 countries.
News For SNY From The Last 14 Days
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April 16, 2014
09:15 EDTSNYImpax launches generic Renvela for kidney disease licensed from Sanofi
Impax Laboratories (IPXL) is commencing shipment of authorized generic Renvela 800 mg tablets, through Global Pharmaceuticals, Impax's generics division. Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Under the terms of a settlement agreement, Sanofi (SNY) company Genzyme agreed to grant Impax a license to sell an allotment of a specified number of bottles of an authorized generic version of Renvela tablets commencing on April 16. Impax continues to pursue approval of its pending Abbreviated New Drug Application for generic Renvela with the FDA.
April 15, 2014
06:32 EDTSNYPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 11, 2014
07:06 EDTSNYVIVUS announces avanafil clinical data presentation
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April 9, 2014
07:09 EDTSNYReckitt Benckiser may be frontrunner for Merck unit, Bloomberg reports
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April 8, 2014
11:03 EDTSNYPiper Jaffray's biopharm analyst holds an analyst/industry conference call
Biopharm Analyst Schimmer discusses PCSK9 Inhibitors and other atherosclerosis approaches on an Analyst/Industry conference call. Relevant companies AEGR, ALNY, AMGN, ARNA, AZN, BMY, CBST, LLY, ESPR, GSK, ICPT, ISIS, MNKD, MRK, OREX, PFE, REGN, RHHBY, SNY and VVUS may be included on the Analyst/Industry conference call to be held on April 10 at 3 pm.
April 7, 2014
05:28 EDTSNYGenzyme to resubmit Lemtrada application for FDA review
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April 3, 2014
06:36 EDTSNYSanofi on lookout for acquisitions, expects growth in Africa, Reuters says
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