Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-08-31 | allogeneic cytomegalovirus cytotoxic T lymphocytes | Atara Biotherapeutics (USA – CA) |
|
Granting of the orphan status in the US |
2017-09-11 | Atara Biotherapeutics (USA – CA) | cancer patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV-PTLD) following a hematopoietic cell transplant (HCT) or solid organ transplant (SOT). | Submission of a Market Application in the US | |
2017-12-26 | 1,2:5,6-dianhydrogalactitol | DelMar Pharmaceuticals (USA - CA) | recurrent glioblastoma | Granting of a Fast Track status |
2017-09-28 | 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt | Trovagene (USA - CA) | acute myeloid leukemia | Granting of the orphan status in the US |
2017-12-12 | Trovagene (USA - CA) | Product launch | ||
2018-02-08 | semaglutide | Novo Nordisk (Denmark) | type 2 diabetes | Granting of a Market Authorisation in the EU |
2018-09-21 | brentuximab vedotin | Seattle Genetics (USA - WA), a wholly owned subsidiary of Takeda Pharmaceutical (Japan) | Acceptation for review of a sNDA | |
2018-01-05 | denosumab | Amgen (USA - CA) | prevention of skeletal-related event (SRE) in patients with multiple myeloma | Granting of a Market Authorisation in the US |
2018-01-09 | lenvatinib mesylate and pembrolizumab | Eisai (Japan) Merck&Co (USA - NJ) | renal cell carcinoma | Granting of the Breakthrough Therapy status |
2017-12-21 | ceftobiprole | Basilea Pharmaceutica (Switzerland) | Staphylococcus aureus bacteremia | Granting of a Fast Track status |
2017-09-07 | adeno-associated viral vector serotype Anc80 containing the truncated human ATP7B gene under the control of the human alpha-1 antitrypsin promoter | Vivet Therapeutics (France) | Wilson's disease | Granting of the orphan status in the US |
2017-10-16 | adenoviral vector of serotype 5 modified to contain a chimeric sequence consisting of a minimal urokinase-type plasminogen activator receptor promoter preceded by three Notch-responsive elements, and coated with oligopeptide end-modified poly (beta-amino) esters | Sagetis Biotech (Spain) | pancreatic cancer | Granting of the orphan status in the EU |
2016-02-04 | peptide carrier fusion protein | Biomay (Austria) | grass pollen allergy | Granting of a patent |
2018-01-29 | FP-1201-lyo (the lyophilised form of Traumakine® (human recombinant interferon-beta 1a) | Faron Pharmaceuticals (Finland) | acute respiratory distress syndrome (ARDS) | Granting of a Fast Track status |
2018-02-01 | Faron Pharmaceuticals (Finland) | Granting of a patent | ||
2018-02-12 | Abeona Therapeutics (USA - NY) | infantile Batten disease or infantile neuronal ceroid lipofuscinosis (INCL) | Granting of the orphan status in the US | |
2018-02-13 | inter-Alpha-Inhibitor-Proteins (IaIp) | Prometic Life Science (Canada) | necrotizing enterocolitis | Granting of the orphan status in the US |
2018-01-17 | apremilast | Celgene (USA - NJ) | pediatric patients with ulcerative colitis | Granting of the orphan status in the US |
2018-01-19 | adeno-associated viral 5 (AAV5) gene therapy - Adeno-associated viral vector serotype 5 encoding a microRNA targeted to human huntingtin gene | Uniqure (The Netherlands) | Sanfilippo B syndrome (rare autosomal recessive lysosomal storage disease, which manifests in young children) | Granting of the orphan status in the EU |
2018-01-08 | upadacitinib | Abbvie (USA - IL) | atopic dermatitis | Granting of the Breakthrough Therapy status |
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