Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-10-07 | adalimumab | Abbvie (USA - IL) | moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to reducing signs and symptoms in patients ages 2 and older |
Granting of a Market Authorisation in the US |
2014-10-07 | vinorelbine | Pierre Fabre Médicament (France) | locally advanced, unresectable, non-small cell lung cancer | Granting of a Market Authorisation in China |
2014-10-07 | vinorelbine | Pierre Fabre Médicament (France) | advanced breast cancer | Granting of a Market Authorisation in China |
2015-01-16 | apremilast | Celgene (USA - NJ) | patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate |
Granting of a Market Authorisation in the EU |
2015-07-10 | brexpiprazole - 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one | Lundbeck (Denmark) Otsuka Pharmaceutical (Japan) | major depressive disorder (MDD) | Granting of a Market Authorisation in the US |
2016-05-31 | drisapersen - exon 51 specific phosphorothioate oligonucleotide | Prosensa (The Netherlands) now BioMarin Pharmaceutical (USA - CA) | Duchenne muscular dystrophy |
Withdrawal of a market application in the EU |
2014-10-09 | qPCR-based in vitro diagnostic test | Mobidiag (Finland) | bacterial gastroenteritis |
Product launch |
2017-04-13 | sapropterin dihydrochloride | BioMarin Pharmaceutical (USA - CA) Merck KGaA (Germany) | hyperphenylalaninaemia phenylketonuria | Patent infringement lawsuit |
2014-10-10 | monoclonal antibody | MedImmune (USA - global biologics arm of AstraZeneca (UK) | prevention of nosocomial pneumonia |
Granting of a Fast Track status |
2014-10-10 | aramchol | Galmed Pharmaceuticals (Israel) | NASH (non-alcoholic steatohepatitis) |
Granting of a Fast Track status |
2017-06-20 | triple-bead mixed amphetamine salts MAS | Shire (UK - USA) | attention-deficit hyperactivity disorder (ADHD) | Granting of a Market Authorisation in the US |
2014-10-11 | recombinant human pentraxin-2 | Promedior (USA - MA) | myelofibrosis |
Granting of the orphan status in the US |
2014-10-11 | donepezil hydrochloride | Eisai (Japan) | dementia with Lewy bodies |
Granting of a Market Authorisation in Japan |
2014-10-11 | Eisai (Japan) | hypervascularized tumors arteriovenous malformations |
Granting of a patent | |
2014-11-20 | portable oximeter | Covidien (Ireland) | Granting of a Market Authorisation in the EU | |
2014-10-13 | genetic testing of Familial Mediterranean Fever and Hypercholesterolemia | Sophia Genetics (Switzerland) | Familial Mediterranean Fever and Hypercholesterolemia |
Granting of a Market Authorisation in the EU |
2015-05-27 | insulin lispro 200 units/ml | Eli Lilly (USA - IN) | type 1 and type 2 diabetes |
Granting of a Market Authorisation in the US |
2014-10-17 | budesonide | Salix Pharmaceuticals (USA - CA) | induction of remission in patients with active mild-to-moderate distal ulcerative colitis | Granting of a Market Authorisation in the US |
2015-02-25 | hydrocodone bitartrate | Teva Pharmaceuticals (Israel) | chronic pain |
Acceptation for review of a NDA |
2016-12-15 | ustekinumab | Janssen-Cilag International, a J&J company (USA - NJ) | treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies |
Submission of a Market Application in the US |
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