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 ...

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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 ...

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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 ...

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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 ...

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NICE wants to stop saying ‘no’ – but needs pharma’s co-operation

18 March 2019 - Suggests Orkambi row has undermined confidence in NICE process. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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