Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2016-11-22 | allogeneic Epstein-Barr virus cytotoxic T lymphocytes | Atara Biotherapeutics (USA – CA) Wainwright Associates (UK) | CMV infection in patients with impaired cell-mediated immunity | Granting of the orphan status in the EU |
2016-12-19 | sodium hyaluronate for peritendinous injection | Anika Therapeutics (USA – MA) | treatment of pain associated with chronic lateral epicondylosis |
Granting of a Market Authorisation in the EU |
2016-07-08 | sofosbuvir and velpatasvir | Gilead (USA - CA) | genotype 1-6 chronic hepatitis C virus (HCV) infection |
Granting of a Market Authorisation in the EU |
2017-05-22 | fluciclovine (18F) | Blue Earth Diagnostics (UK) | detection of recurrence of prostate cancer | Granting of a Market Authorisation in the EU |
2016-03-18 | obiltoxaximab | Elusys Therapeutics (USA - NY) | inhalation anthrax |
Granting of a Market Authorisation in the US |
2016-12-13 | follitropin delta | Granting of a Market Authorisation in the EU | ||
2017-01-30 | hydroxypioglitazone -5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride | Minoryx Therapeutics (Spain) | X-linked adrenoleukodystrophy | Granting of the orphan status in the US |
2016-11-18 | adeno-associated viral vector serotype 8 containing the human UGT1A1 gene | Audentes Therapeutics (USA - CA) | Crigler-Najjar syndrome |
Granting of the orphan status in the EU |
2016-11-18 | allogeneic cytomegalovirus-specific cytotoxic T lymphocytes | Wainwright Associates (UK) | cytomegalovirus infection in patients with impaired cell-mediated immunity |
Granting of the orphan status in the EU |
2016-11-18 | allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2 and dexamethasone | Fate Therapeutics (USA - CA) | haematopoietic stem cell transplantation |
Granting of the orphan status in the EU |
2016-11-18 | live-attenuated non-replicative Pseudomonas aeruginosa strain expressing large T antigen of Merkel cell polyomavirus | Apcure (France) | Merkel cell carcinoma |
Granting of the orphan status in the EU |
2016-11-18 | N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide | Emas Pharma (UK) | acute pancreatitis |
Granting of the orphan status in the EU |
2016-11-18 | R-azasetron besylate | Sensorion (France) | sudden sensorineural hearing loss | Granting of the orphan status in the EU |
2016-11-18 | synthetic human hepcidin | Emas Pharma (UK) | sickle cell disease |
Granting of the orphan status in the EU |
2016-11-18 | vaccine consisting of 5 survivin peptides with different human leukocyte antigen restrictions | Dr Ulrich Granzer (Germany) | ovarian cancer |
Granting of the orphan status in the EU |
2016-11-18 | valproic acid | Valcuria (Sweden) | diffuse large B-cell lymphoma |
Granting of the orphan status in the EU |
2016-11-18 | 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde | SynteractHCR Deutschland (Germany) | sickle cell disease |
Granting of a Market Authorisation in the EU |
2016-11-18 | adeno-associated viral vector serotype 8 containing the human glucose-6-phosphatase gene | Pharma Gateway (Sweden) | glycogen storage disease type Ia |
Granting of the orphan status in the EU |
2016-11-18 | alpha-tocopherol | Université de Montpellier (France) | facioscapulohumeral muscular dystrophy | Granting of the orphan status in the EU |
2016-11-18 | ascorbic acid | Université de Montpellier (France) | facioscapulohumeral muscular dystrophy |
Granting of the orphan status in the EU |
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