Blog
RSS FeedPosted by Michael Wonder on 19 Aug 2016
European Commission grants marketing authorisation for Teva’s Cinqaero (reslizumab)
18 August 2016 - First intravenous anti-IL-5 biologic therapy for severe eosinophilic asthma now approved in Europe. ...
Posted by Michael Wonder on 18 Aug 2016
Patents versus market exclusivity: why does it take so long to bring generics to market in the US?
17 August 2016 - It’s easy to point a finger at the US and blame the pharmaceutical companies’ lawyers for ...
Posted by Michael Wonder on 18 Aug 2016
FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery
18 August 2016 - The U.S. FDA today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart ...
Posted by Michael Wonder on 18 Aug 2016
Portola Pharmaceuticals receives complete response letter from FDA for biologics license application for AndexXa (andexanet alfa)
17 August 2016 - Portola Pharmaceuticals today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 18 Aug 2016
NICE recommends crizotinib, first pill for lung cancer
18 August 2016 - New draft guidance from NICE means hundreds of people will now have access to crizotinib, a twice-a-day ...
Posted by Michael Wonder on 15 Aug 2016
Emtricitabine with tenofovir alafenamide fumarate in HIV infection: additional benefits not covered
15 August 2016 - Deviation from the appropriate comparator therapy/higher loss for certain patients. ...
Posted by Michael Wonder on 13 Aug 2016
TGA approves Briviact (brivaracetam)
12 August 2016 - The TGA has approved UCB's Briviact (brivaracetam). ...
Posted by Michael Wonder on 13 Aug 2016
TGA approves Tagrisso (osimertinib mesylate)
12 August 2016 - The TGA has approved AstraZeneca's Tagrisso (osimertinib mesylate). ...
Posted by Michael Wonder on 12 Aug 2016
CADTH issues initial pERC outcome for Lynparza (olaparib)
5 August 2016 - CADTH has published pERC's initial recommendation on the use of olaparib for use as monotherapy maintenance treatment ...
Posted by Michael Wonder on 12 Aug 2016
Health Canada approves new indication for Jardiance (empagliflozin) tablets for adults with type 2 diabetes and established cardiovascular disease
11 August 2016 - Approval based on cardiovascular outcome clinical trial EMPA-REG OUTCOME, which demonstrated empagliflozin significantly reduced the incidence of ...
Posted by Michael Wonder on 12 Aug 2016
Thousands to benefit as NICE set to recommend drug to prevent heart attacks and strokes
12 August 2016 - NICE has published draft guidance recommending anti-clotting drug ticagrelor 60 mg with aspirin for people who have ...
Posted by Michael Wonder on 10 Aug 2016
Heron Therapeutics announces U.S. FDA approval of Sustol (granisetron) extended-release injection for the prevention of chemotherapy-induced nausea and vomiting
10 August 2016 - Sustol is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea ...
Posted by Michael Wonder on 10 Aug 2016
PBAC Drug Utilisation Sub Committee outcome statement
10 August 2016 - The outcome statement from the PBAC Drug Utilisation Sub Committee June 2016 meeting is now available. ...
Posted by Michael Wonder on 10 Aug 2016
Cardiome announces Xydalba single dose infusion approval by European Medicines Agency
9 August 2016 - Cardiome Pharma Corporation has announced that Xydalba (dalbavancin hydrochloride) has been approved by the EMA for administration ...
Posted by Michael Wonder on 09 Aug 2016
NICE issues draft guidance on the use of talimogene laherparepvec
9 August 2016 - Talimogene laherparepvec (Imlygic) is the first cellular therapy to be appraised by NICE. ...