Home » canada
Category Archives: canada
Bayer receives Canadian approval for Nexavar to treat differentiated thyroid cancer
SORAFENIB
Bayer receives Canadian approval for Nexavar to treat differentiated thyroid cancer
Health Canada has approved Bayer’s Nexavar (sorafenib tablets) for treatment of patients with locally advanced or metastatic, progressive, differentiated (papillary/follicular/Hurthle cell) thyroid carcinoma, refractory to radioactive iodine.
Nexavar’s approval in Canada is supported by a positive outcome from the Phase III DECISION (‘stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer’) trial.
FOOTBALL BRAZIL 2014
Health Canada approves Levemir® FlexTouch® prefilled insulin pen for the treatment of type 1 and type 2 diabetes
MISSISSAUGA, ON, Oct. 18, 2013 /CNW/ – Novo Nordisk today announced that Health Canada has approved Levemir® FlexTouch®, a disposable prefilled insulin pen containing Levemir® (insulin detemir). Levemir® FlexTouch® has been designed to improve ease of use for insulin administration and to help decrease barriers to good treatment adherence for Canadians living with type 1 and type 2 diabetes mellitus (diabetes).
The approval was also announced at the 2013 Vascular Conference in Montreal, Quebec.
Health Canada approves Levemir® FlexTouch® prefilled insulin pen for the treatment of type 1 and type 2 diabetes
http://www.pharmalive.com/health-canada-approves-levemir-flextouch
Diet Pill Dilemma: Why Is FDA Approving Drugs When Europe Isn’t?
We’ve all dreamt of popping a pill to help us safely lose weight, or at least eat that chocolate cake without guilt. But alas, even though the Food and Drug Administration has approved two new diet drugs in recent months, that dream probably isn’t any closer to reality.
In the current issue of the BMJ (formerly the British Medical Journal), Sidney Wolfe, founder of the advocacy group Public Citizen, slams the FDA for approving the drugs – lorcaserin (US brand name Belviq) and topiramate (called Qsymia). The FDA’s European counterpart rejected both of them because of heart risks that turned up during preliminary trials.
read all this at
http://commonhealth.wbur.org/2013/08/diet-pill-dilemma-why-is-fda-approving-drugs-when-europe-isnt
Health Canada Approves ThromboGenics’ JETREA® for the Treatment of Symptomatic Vitreomacular Adhesion
LEUVEN, Belgium, August 16, 2013 /PRNewswire/ —
Canada is first market outside the US and Europe where JETREA ® is approved
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that Health Canada has approved JETREA® (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA). The priority review of the New Drug Submission for JETREA in Canada was conducted within 180 calendar days. Canada is the first market where JETREA® is approved outside the US and Europe. ThromboGenics’ partner Alcon holds the commercialization rights to JETREA® outside the US and will be responsible for the launch of the drug in Canada.
read all at
http://www.pharmalive.com/health-canda-approves-jetrea-for-vma
Ocriplasmin (trade name Jetrea) is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface. It is used for treatment of symptomatic vitreomacular adhesion, for which it received FDA approval on 17 October 2012. It works by dissolving the proteins that link the vitreous to the macula, resulting in posterior detachment of the vitreous from the retina.[1]
References
1 Stalmans, P; Benz, MS; Gandorfer, A; Kampik, A; Girach, A; Pakola, S; Haller, JA; MIVI-TRUST Study, Group (2012 Aug 16). “Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes.”. The New England journal of medicine 367 (7): 606–15. PMID 22894573.