Pancreatic Safety of Incretin-Based Drugs — FDA and EMA Assessment
Amy G. Egan, Eberhard Blind, Kristina Dunder, et al. N Engl J Med 2014; 370:794-797 http://www.nejm.org/doi/full/10.1056/NEJMp1314078
Leggi
Giallo
Le Breaking News di colore giallo sono relative a notizie dalle agenzie regolatorie o da società scientifiche: nuovi farmaci, ritiri, eventi avversi rilevanti…
Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication – FDA to Review Heart Failure Risk
02/11/2014 - Drug Safety Communication - FDA http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385471.htm
Leggi
Testosterone Products: Drug Safety Communication – FDA Investigating Risk of Cardiovascular Events
01/31/2014 - Drug Safety Communication - FDA http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm
Leggi
FDA Commissioner Margaret A. Hamburg’s Statement on the 50th Anniversary Surgeon General’s Report on Smoking and Health
For Immediate Release: Jan. 17, 2014 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382100.htm
Leggi
The Health Consequences of Smoking – 50 Years of Progress: A Report of the Surgeon General
http://www.surgeongeneral.gov/library/reports/50-years-of-progress/index.html
Leggi
FDA NEWS RELEASE
Jan. 8, 2014 FDA approves Farxiga (dapaglifozin) to treat type 2 diabetes http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm380829.htm
Leggi
Le nuove norme per la rimborsabilità a carico del SSN dei farmaci agenti sul sistema delle incretine
Nuove norme per la rimborsabilità a carico del SSN dei farmaci agenti sul sistema delle incretine: - Obbligo di piano terapeutico web-based per tutti - Nuove norme sulla rimborsabilità legate ai valori di Hb glicata attuali e ai target - Esclusione dalla rimborsabilità della monoterapia con l'eccezione…
Leggi
European Medicines Agency – PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels.
08/11/2013 EMA Press release http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/11/WC500154014.pdf
Leggi
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage
FDA Safety [Posted 08/15/2013] http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm365302.htm
Leggi
European Medicines Agency – Investigation into GLP-1 based diabetes therapies concluded
No new concerns for GLP-1 therapies identified on the basis of available evidence. 26/07/2013 EMA Press release http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/07/news_detail_001856.jsp&mid=WC0b01ac058004d5c1
Leggi