Regorafenib in metastatic colorectal cancer: still only a hint of a minor additional benefit

4 January 2016 - After the expiry of the decision it made in 2014, the IQWIG has the reached same ...

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ERC recommends Jakavi for patients with polycythema vera who are resistant to or intolerant of hydroxyurea

7 January 2016 - The ERC has recommended the funding of ruxolitinib phosphate (Jakavi) so long as its cost-effectiveness is ...

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Nivolumab in melanoma: data subsequently submitted improve assessment result

7 January 2016 - In an addendum, the IQWiG assessed study data submitted by BMS. In treatment-naive patients whose tumour is ...

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Registration of new chemical entities in Australia in 2015

5 January 2016 - Each year, approximately 40 new prescription medicines containing new active substances are registered. ...

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Pomalidomide in multiple myeloma: no sign of an additional clinical benefit

4 January 2016 - The IQWiG examined whether pomalidomide offers an added benefit over the appropriate comparator therapy. No such added ...

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Dabrafenib in combination with trametinib in advanced melanoma with BRAF V600 mutation: indication of added benefit says IQWiG

4 January 2016 - According to the findings, no added benefit is proven for trametinib monotherapy because of a lack of ...

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Human medicines: EMA highlights of 2015

12 Januaru 2016 - The EMA has released an overview of its 2015 key recommendations in relation to the marketing authorisations ...

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January 2016 SMC decisions news release

11 January 2016 - The Scottish Medicines Consortium, which reviews newly licensed medicines, has today published advice accepting five new medicines ...

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AbbVie's Humira (adalimumab) receives first and only Health Canada approval for moderate to severe hidradenitis suppurativa

6 January 2016 - This follows approval from the FDA and the European Commission. Humira is now the first and only ...

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Additional outcome from the November 2015 PBAC meeting

7 January 2016 - The PBAC decided not to recommend pirfenidone for PBS listing for idiopathic pulmonary fibrosis on the ...

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2015: another strong year for patients in need of new drug therapies

4 January 2016 - In 2015, FDA’s CDER approved 45 novel new therapies – significantly more than the average of 28 ...

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NICE issues revised draft guidance on ezetimibe for hypercholesterolaemia

24 December 2015 - NICE is reviewing its guidance on ezetimibe (Ezetrol, MSD) for adults with primary (heterozygous-familial and non-familial) hypercholesterolaemia. ...

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FDA approves Zurampic to treat high blood uric acid levels associated with gout

22 December 2015 - The U.S. FDA today approved Zurampic (lesinurad) to treat high levels of uric acid in the blood ...

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FDA approves new orphan drug to treat pulmonary arterial hypertension

22 December 2015 - On December 21, the U.S. FDA approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension ...

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Evolocumab: no hint of added clinical benefit according the IQWiG in Germany

15 December 2015 - The dossier contained no suitable data for hypercholesterolaemia or for mixed dyslipidaemia. ...

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