Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-09-22 | sirukumab | Janssen-Cilag International, a J&J company (USA - NJ) GSK (UK) | moderately to severely active rheumatoid arthritis | Refusal of a Market Autorisation in the US |
2016-09-08 | coversin | Akari Therapeutics (USA - NY - UK) | paroxysmal nocturnal hemoglobinuria |
Granting of the orphan status in the US |
2016-06-01 | nelipepimut-S | Galena BioPharma (USA - OR) | HER2 expressing cancers |
Granting of a Fast Track status |
2016-09-12 | anagrelide controlled release | Galena Biopharma (USA - OR) | myeloproliferative neoplasms essential thrombocythemia |
Granting of a patent |
2017-07-20 | darunavir, cobicistat, emtricitabine, tenofovir alafenamide | Janssen-Cilag International, a J&J company (USA - NJ) | HIV-1 infection | Positive opinion for the granting of a Market Authorisation in the EU |
2016-08-29 | synthetic double-stranded small interfering RNA (siRNA) oligonucleotide targeting delta-aminoevulinic acid synthase 1 | Alnylam Therapeutics (USA - MA) | acute hepatic porphyria |
Granting of the orphan status in the US |
2016-08-22 | (1,3)-ß-D-glucan synthesis inhibitor | Scynexis (USA - NJ) | invasive Aspergillus infections |
Granting of the orphan status in the US |
2016-05-10 | enfumafungin derivative B-(1,3)-D-glucan synthestis inhibitor | Scynexis (USA - NJ) | invasive Candida infections, including candidemia |
Granting of the orphan status in the US |
2016-09-13 | hafnium oxide crystals | Nanobiotix (France) | locally-advanced soft tissue sarcoma (STS) |
Submission of a Market Application in the EU |
2016-09-21 | canagliflozin and metformin | Janssen Pharmaceuticals, a J&J company (USA - NJ) | type 2 diabetes |
Granting of a Market Authorisation in the US |
2016-11-11 | ustekinumab | Janssen-Cilag International, a J&J company (USA - NJ) | adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFalpha) antagonist or have medical contraindications to such therapies |
Submission of a Market Application in the EU |
2016-09-16 | insulin aspart | Novo Nordisk (Denmark) | children with diabetes from as young as one year old |
Positive opinion for the granting of a Market Authorisation in the EU |
2017-05-30 | nusinersen - antisense oligonucleotide targeted to the SMN2 gene | Biogen (USA - MA) Ionis Pharmaceuticals (USA - CA) | spinal muscular atrophy (SMA) | Granting of a Market Authorisation in the EU |
2016-09-28 | alogliptin and metformin | Takeda Pharmaceutical (Japan) | type 2 diabetes |
Submission of an NDA |
2016-12-14 | crisaborole topical ointment (AN2728) | Anacor Pharmaceuticals (US - CA), now Pfizer (USA - NY) | mild-to-moderate atopic dermatitis in children and adults |
Granting of a Market Authorisation in the US |
2016-09-01 | binimetinib | Array BioPharma (USA - CO) | advanced NRAS-mutant melanoma | Withdrawal of a market application in the US |
2018-08-23 | cytarabine and daunorubicin liposome injection | Jazz Pharmaceuticals (Ireland) | acute myeloid leukemia | Granting of a Market Authorisation in the EU |
2016-09-28 | recombinant adeno-associated virus serotype 8 vector encoding human glucose-6-phosphatase-alpha (G6Pase or G6PC) | Dimension Therapeutics (USA - MA) | glycogen storage disease type Ia (von Gierke Disease) |
Granting of the orphan status in the US |
2016-09-19 | adeno-associated virus delivered transgene of follistatin | Milo Biotechnology (USA - OH) | inclusion body myositis |
Granting of the orphan status in the US |
2017-12-20 | biosimilar version of trastuzumab | Samsung Bioepis (Republic of Korea) | early breast cancer, metastatic breast cancer, metastatic gastric cancer | Acceptation for review of a NDA |
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