Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-02-02 | QGC001 | Quantum Genomics (France) | high blood pressure | Granting of a patent |
2018-07-30 | erenumab | Amgen (USA - CA) Novartis (Switzerland) | migraine | Granting of a Market Authorisation in the EU |
2017-06-23 | rituximab and hyaluronidase human | Roche (Switzerland) | previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), previously untreated and previously treated chronic lymphocytic leukaemia (CLL) | Granting of a Market Authorisation in the US |
2018-02-23 | emicizumab (ACE910 - anti-factor IXa x anti-factor X humanized bispecific antibody) | Chugai Pharmaceutical (Japan) Roche (Switzerland) | hemophilia A with factor VIII inhibitors in adult and pediatric patients | Granting of a Market Authorisation in Japan |
2017-07-24 | Lyme borreliosis vaccine | Valneva (France - Austria) | Lyme disease | Granting of a Fast Track status |
2017-07-25 | certolizumab pegol | UCB (Belgium) Dermira (USA - CA) | moderate to severe chronic plaque psoriasis | Submission of a Market Application in the US |
2018-01-08 | romosozumab | Amgen (USA - CA) UCB (Belgium) |
|
Submission of a Market Application in the EU |
2018-01-08 | hepatitis B vaccine | Dynavax (USA - CA) | immunization against hepatitis B | Product launch |
2018-09-24 | durvalumab | AstraZeneca (UK) |
|
Granting of a Market Authorisation in the EU |
2017-04-06 | direct-to-consumer genetic health risk reports | 23andMe (USA - CA) | Parkinson’s disease, late-onset Alzheimer’s disease, celiac disease, alpha-1 antitrypsin deficiency, early-onset primary dystonia, factor XI deficiency, Gaucher disease type 1, Glucose-6-Phosphate Dehydrogenase deficiency, hereditary hemochromatosis and hereditary thrombophilia | Granting of a Market Authorisation in the US |
2017-05-09 | avelumab - recombinant human monoclonal IgG1 antibody against programmed death ligand-1 (anti-PD-L1) | EMD Serono - Merck KGaA (Germany) Pfizer (USA - NY) |
|
Granting of a Market Authorisation in the US |
2017-03-23 | naldemedine | Shionogi (Japan) | opioid-induced constipation (OIC) | Granting of a Market Authorisation in the US |
2017-04-11 | valbenazine | Neurocrine Biosciences (USA - CA) | tardive dyskinesia | Granting of a Market Authorisation in the US |
2018-07-26 | abaloparatide | Radius Health (USA - MA) | postmenopausal women with osteoporosis at high risk for fracture | Refusal of a Market Autorisation in the EU |
2017-06-22 | epoetin alfa biosimilar | Pfizer (USA - NY) |
|
Refusal of a Market Autorisation in the US |
2018-03-08 | delafloxacin | Melinta Therapeutics (USA - CT) |
|
Submission of a Market Application in the EU |
2017-09-14 | guselkumab | Janssen-Cilag International, a J&J company (USA - NJ) | severe plaque psoriasis | Granting of a Market Authorisation in the EU |
2017-08-01 | enasidenib (AG-221/CC-90007) | Celgene (USA - NJ) Agios Pharmaceuticals (USA - MA) | relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation | Granting of a Market Authorisation in the US |
2017-04-18 | Japan Vaccine (Japan) GSK (UK) Daiichi Sankyo (Japan) | prevention of herpes zoster (shingles) in people aged 50 years or over | Granting of a Market Authorisation in the EU | |
2018-05-16 | dolutegravir and rilpivirine | ViiV Healthcare (UK - USA) | maintenance treatment of HIV-1 infection | Granting of a Market Authorisation in the EU |
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