Isturisa (osilodrostat) approved

15 January 2020 - Recordati announces that the European Commission has granted marketing authorisation for the orphan medicinal product Isturisa (osilodrostat), ...

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Janssen seeks expanded use of Spravato (esketamine) nasal spray in Europe as a treatment for depressive symptoms in adults with major depressive disorder who have current suicidal ideation with intent

15 January 2020 - In two pivotal Phase 3 trials, Spravato combined with comprehensive standard of care achieved statistically significant ...

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PTC Therapeutics provides corporate update

13 January 2020 - PTC-AADC MAA submitted; BLA now expected to be submitted in 2Q 2020. ...

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Sanofi secures expanded European approval for Toujeo in type 1 diabetes

10 January 2020 - Sanofi has revealed that the European Commission has expanded the existing label for Toujeo (insulin glargine ...

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Acerus provides update on Natesto approval process in Europe

10 January 2020 - Acerus Pharmaceuticals today announced that the dossier filed as a decentralised Procedure in 19 European countries ...

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ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available

10 January 2020 - ViiV Healthcare with Pfizer and Shionogi, today announced the submission of a marketing authorisation application to ...

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Human medicines: highlights of 2019

9 January 2020 - EMA has published a review of its key recommendations in 2019 on the authorisation and safety ...

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Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for pemigatinib in patients with cholangiocarcinoma

7 January 2020 - Incyte today announced the validation of the Company’s marketing authorisation application for pemigatinib for the treatment of ...

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Kyowa Kirin announces marketing authorisation application for istradefylline validated by European Medicines Agency

6 January 2020 - Kyowa Kirin today announces that its marketing authorisation application for istradefylline (KW-6002) as an adjunctive treatment ...

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Beyond “Intent‐to‐treat” and “Per protocol”: improving assessment of treatment effects in clinical trials through the specification of an estimand

27 December 2019 - There is a key problem in randomised clinical trials as outcomes can be distorted due to ...

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EMA accepts regulatory submission for Lumoxiti in relapsed or refractory hairy cell leukaemia

2 January 2020 - Innate Pharma today announced that the EMA has accepted the marketing authorisation application for Lumoxiti (moxetumomab ...

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Aerie Pharmaceuticals announces acceptance for review of the Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% marketing authorisation application in Europe

2 January 2020 - Aerie Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for Roclanda ...

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U.S. FDA approves Eisai's Dayvigo (lemborexant) for treatment of insomnia in adult patients

23 December 2019 - Orexin receptor antagonist proven effective for both sleep onset and sleep maintenance in clinical development program of ...

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European Medicines Agency validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A

23 December 2019 - Potential first gene therapy in Europe directed at any type of haemophilia. ...

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Bristol-Myers Squibb receives European Commission approval for Revlimid (lenalidomide) in combination with rituximab for the treatment of adult patients with previously treated follicular lymphoma

20 December 2019 - Revlimid plus rituximab is the first chemotherapy-free combination regimen approved in Europe for patients with follicular lymphoma ...

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