Blog
RSS FeedPosted by Michael Wonder on 21 Mar 2019
Institute for Clinical and Economic Review releases draft evidence report on esketamine for treatment-resistant depression
21 March 2019 - Public comment period now open until 17 April 2019; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 21 Mar 2019
FDA approves new device for treating moderate to severe chronic heart failure in patients
21 March 2019 - The U.S. FDA today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure ...
Posted by Michael Wonder on 21 Mar 2019
Jazz Pharmaceuticals announces U.S. FDA approval of Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea
20 March 2019 - Sunosi is the first and only dual-acting dopamine and norepinephrine re-uptake inhibitor approved by the FDA to ...
Posted by Michael Wonder on 19 Mar 2019
FDA approves first treatment for post-partum depression
19 March 2019 - The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous use for the treatment ...
Posted by Michael Wonder on 19 Mar 2019
NICE wants to stop saying ‘no’ – but needs pharma’s co-operation
18 March 2019 - Suggests Orkambi row has undermined confidence in NICE process. ...
Posted by Michael Wonder on 19 Mar 2019
FDA approves Genentech’s Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer
18 March 2019 - First new initial treatment option approved by the U.S. FDA for people with ES-SCLC in more than ...
Posted by Michael Wonder on 19 Mar 2019
New treatment option now available in Canada for newly diagnosed patients with advanced lung cancer
18 March 2019 - Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy reduced the risk of death by half compared ...
Posted by Michael Wonder on 18 Mar 2019
Allergan announces FDA approval of Avycaz (ceftazidime and avibactam) for paediatric patients
18 March 2019 - Label now includes new data on use of Avycaz for treatment of cUTI and cIAI in paediatric ...
Posted by Michael Wonder on 18 Mar 2019
New early breast cancer drug to reduce risk of recurrence or death approved for Australian women
18 March 2019 - Nerlynx (neratinib) now approved by the Therapeutic Goods Administration for Australian women. ...
Posted by Michael Wonder on 18 Mar 2019
Praluent (alirocumab) now approved in European Union to reduce the risk of cardiovascular events in patients with established cardiovascular disease
15 March 2019 - Approval is based on ODYSSEY OUTCOMES trial of 18,924 patients who recently suffered an acute coronary syndrome ...
Posted by Michael Wonder on 16 Mar 2019
European Commission approves Roche’s MabThera (rituximab) for a rare auto-immune disease
15 March 2019 - MabThera is now approved in Europe to treat four auto-immune diseases. ...
Posted by Michael Wonder on 15 Mar 2019
PBAC Public Summary Documents - November 2018 meeting (rejections and deferrals)
15 March 2019 - The Public Summary Documents (first time rejections and deferrals) from the November 2018 PBAC meeting are now ...
Posted by Michael Wonder on 14 Mar 2019
Institute for Clinical and Economic Review releases draft evidence report on siponimod for treating secondary progressive multiple sclerosis
14 March 2019 - Public comment period now open until 10 April 2019; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 14 Mar 2019
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with chemotherapy for first-line treatment of adults with metastatic squamous non-small cell lung cancer
14 March 2019 - European approval based on KEYNOTE-407 study results demonstrating significant improvement in overall survival with Keytruda in combination ...
Posted by Michael Wonder on 14 Mar 2019
European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors
14 March 2019 - First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis, in a prospective intra-patient ...