Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-10-27 | elagolix | Abbvie (USA - IL) |
|
Submission of a Market Application in the US |
2018-02-20 | Portola Pharmaceuticals (USA - CA) | prevention of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness with risk factors for VTE | Negative opinion for the granting of a Market Authorisation in the EU | |
2018-02-28 | calaspargase pegol | Shire (UK - USA) | acute lymphoblastic leukemia (ALL) | Acceptation for review of a NDA |
2017-12-20 | macimorelin | Aeterna Zentaris (Canada) | diagnosis of patients with adult growth hormone deficiency (AGHD) | Granting of a Market Authorisation in the US |
2018-07-26 | betrixaban | Portola Pharmaceuticals (USA - CA) | prevention of venous thromboembolism (VTE) | Negative opinion for the granting of a Market Authorisation in the EU |
2018-03-29 | sotagliflozin | Sanofi (France) | type 1 diabetes | Acceptation for review of a NDA |
2018-10-04 | emicizumab (ACE910 - anti-factor IXa x anti-factor X humanized bispecific antibody) | Chugai Pharmaceutical (Japan) Roche (Switzerland) | hemophilia A without factor VIII inhibitors | Granting of a Market Authorisation in the US |
2018-10-05 | inotersen | Akcea Therapeutics (USA - CA) Ionis Pharmaceuticals (USA - CA) |
|
Granting of a Market Authorisation in the US |
2018-10-12 | rivaroxaban | Bayer Healthcare (Germany) Janssen Research & Development, a J&J company (USA - NJ) |
|
Granting of a Market Authorisation in the US |
2018-08-31 | daratumumab in combination with bortezomib, melphalan and prednisone | Janssen Biotech, a J&J company (USA - NJ) |
|
Granting of a Market Authorisation in the EU |
2018-07-26 | biosimilar epoetin alfa | Medice Arzneimittel Pütter GmbH & Co (Germany) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2018-09-21 | pegfilgrastim - biosimilar version of Neulasta® | Accord Healthcare Ltd (UK) wholly owned subsidiary of Intas Pharmaceuticals (India) |
|
Granting of a Market Authorisation in the EU |
2018-09-20 | biosimilar version of adalimumab Humira® | Mylan (USA - PA) Fujifilm Kyowa Kirin Biologics (Japan) |
|
Granting of a Market Authorisation in the EU |
2018-09-20 | encorafenib in combination with binimetinib and cetuximab | Array BioPharma (USA - CO) Pierre Fabre Médicament (France) |
|
Granting of a Market Authorisation in the EU |
2017-11-30 | next generation sequencing (NGS) based in vitro diagnostic (IVD) to detect genetic mutations in 324 genes and two genomic signatures | Foundation Medicine (USA - MA) | solid tumors | Granting of a Market Authorisation in the US |
2017-05-01 | alicaforsen | Atlantic Healthcare (UK) | pouchitis | Submission of an NDA |
2018-08-21 | adeno-associated viral vector serotype 8 containing the human MTM1 gene | Audentes Therapeutics (USA - CA) |
|
Granting of a Fast Track status |
2018-08-13 | omalizumab | Roche (Switzerland) | food allergies | Granting of the Breakthrough Therapy status |
2017-05-31 | Amicus Therapeutics (USA - NJ) | epidermolysis bullosa | Patent infringement lawsuit | |
2017-05-31 | Amicus Therapeutics (USA - NJ) | epidermolysis bullosa | Patent infringement lawsuit |
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