Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-08-03 | glecaprevir/pibrentasvir | Abbvie (USA - IL) | chronic hepatitis C virus (HCV) infection in adults (genotypes 1-6) | Granting of a Market Authorisation in the US |
2017-07-18 | sofosbuvir, velpatasvir (GS-5816) and voxilaprevir (GS-9857) | Gilead Sciences (USA - CA) | chronic hepatitis C | Granting of a Market Authorisation in the EU |
2017-07-26 | fulvestrant | AstraZeneca (UK) | estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women | Granting of a Market Authorisation in the EU |
2017-12-22 | PEGylated recombinant phenylalanine ammonia lyase enzyme | Biomarin Pharmaceutical (USA - CA) | phenylketonuria | Acceptation for review of a NDA |
2017-02-01 | elobixibat | Albireo Pharma (USA - MA) EA Pharma (Japan) | chronic constipation | Submission of an NDA |
2017-05-16 | (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid | Albireo Pharmaceuticals (USA - MA) Albireo (Sweden) | nonalcoholic steatohepatitis (NASH) | Granting of a patent |
2017-05-02 | Roche (Switzerland) | urothelial carcinoma | Granting of a Market Authorisation in the US | |
2017-01-23 | cysteamine hydrochloride | Orphan Europe, part of Recordati Group (Italy) | corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis | Granting of a Market Authorisation in the EU |
2017-05-16 | biosimilar version of Humira® (adalimumab) | Coherus Biosciences (USA - CA) | Patent infringement lawsuit | |
2018-10-15 | givosiran | Alnylam Therapeutics (USA - MA) | acute hepatic porphyria (AHP) | Submission of an NDA |
2018-09-17 | tildrakizumab | Merck&Co (USA - NJ) Sun Pharmaceutical Industries (India) Almirall (Spain) |
|
Granting of a Market Authorisation in the EU |
2017-02-24 | Auris Medical (Switzerland) | acute sensorineural (inner ear) hearing loss | Granting of a Fast Track status | |
2017-06-19 | nelotanserin | Axovant Sciences (USA - NY) | visual hallucinations disorder in dementia with Lewy bodies | Granting of a Fast Track status |
2017-02-01 | L-glutamine | Emmaus Life Sciences (USA) | diverticulosis | Granting of a patent |
2017-06-28 | recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted | Catalyst Biosciences (USA - CA)/Voisin Consulting (France) | hemophilia B | Granting of the orphan status in the EU |
2017-06-15 | oxymetazoline hydrochloride | RDD Pharma (Israel) | spinal cord injury | Positive opinion for the granting of the orphan status in the EU |
2017-06-15 | recombinant human antibody directed against misfolded human superoxide dismutase 1 | The Medical & Regulatory Partnership (UK) | amyotrophic lateral sclerosis | Positive opinion for the granting of the orphan status in the EU |
2017-06-15 | sirolimus | Raremoon Consulting (UK - USA - MD) | pachyonychia congenita | Positive opinion for the granting of the orphan status in the EU |
2017-06-15 | (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4- yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine | PhaRA (Belgium) | gastrointestinal stromal tumours (GIST) | Positive opinion for the granting of the orphan status in the EU |
2017-06-15 | autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor | Celgene (USA - NJ) | diffuse large B-cell lymphoma | Positive opinion for the granting of the orphan status in the EU |
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