Blog
RSS FeedPosted by Michael Wonder on 22 Aug 2016
European Commission grants marketing authorization for Gilead’s once-daily Truvada for reducing the risk of sexually acquired HIV-1
22 August 2016 - Truvada is the first anti-retroviral medicine to be licensed in Europe for pre-exposure prophylaxis, in combination with ...
Posted by Michael Wonder on 22 Aug 2016
FDA approves Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules CII with abuse-deterrent properties for the management of pain
19 August 2016 - Pfizer announced today that the U.S. FDA has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release ...
Posted by Michael Wonder on 21 Aug 2016
Insights from the PBAC July 2016 meeting
22 August 2016 - The publication of the outcomes from the PBAC July 2016 meeting presents another opportunity to study ...
Posted by Michael Wonder on 21 Aug 2016
Summary of the outcomes from the PBAC July 2016 meeting
19 August 2016 - The outcomes from the PBAC July 2016 meeting are now in the public domain. ...
Posted by Michael Wonder on 19 Aug 2016
NICE issues draft guidance on the first-line use of sorafenib tosylate (Nexavar) in advanced/metastatic hepatocellular carcinoma
19 August 2016 - The merits of Nexavar in liver cancer have been reviewed by NICE under the CDF rapid reconsideration ...
Posted by Michael Wonder on 19 Aug 2016
HIV prevention drug Truvada won't be subsidised in Australia anytime soon
19 August 2016 - An expensive combination product that prevents people from getting HIV won't be funded by taxpayers in Australia ...
Posted 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 ...