Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-01-15 | allogeneic, umbilical cord blood-derived, ex vivo-expanded, haematopoietic CD133+ cells / allogeneic, umbilical cord blood-derived, non-expanded, haematopoietic CD133- cells | Regulatory Resources Group Ltd (UK) | acute myeloid leukaemia |
Granting of the orphan status in the EU |
2015-01-15 | chimeric monoclonal antibody to O-acetyl-GD2 antigen | Atlab Pharma (France) | neuroblastoma |
Granting of the orphan status in the EU |
2015-01-15 | emtricitabine | Dr Yanick Crow (UK) | Aicardi-Goutières syndrome |
Granting of the orphan status in the EU |
2015-01-15 | herpes simplex type 1 virus containing cellular B-myb gene as tumour-specific promoter | Karcinolys (France) | pancreatic cancer |
Granting of the orphan status in the EU |
2015-01-15 | recombinant human aspartylglucosaminidase | ACE Biosciences, Zymenex group (Denmark) | aspartylglucosaminuria |
Granting of the orphan status in the EU |
2015-01-15 | allogeneic peripheral blood mononuclear cells induced to an early apoptotic state | Richardson Associates Regulatory Affairs Ltd (UK) | prevention of graft-versus-host disease |
Granting of the orphan status in the EU |
2015-01-15 | chimeric fusion protein of recombinant human alpha-N-acetylglucosaminidase and human insulinlike growth factor 2 | BioMarin Europe Ltd (UK) BioMarin | mucopolysaccharidosis type IIIB (Sanfilippo B syndrome) |
Granting of the orphan status in the EU |
2015-01-15 | ceftriaxone | Ospedale San Raffaele (Italy) | spinocerebellar ataxia |
Granting of the orphan status in the EU |
2015-01-15 | sodium thiosulfate | Hope Pharmaceuticals (USA - AZ) | calciphylaxis |
Granting of the orphan status in the EU |
2015-01-15 | tenofovir disoproxil fumarate | Dr Yanick Crow (UK) | Aicardi-Goutières syndrome |
Granting of the orphan status in the EU |
2015-01-15 | adeno-associated viral vector serotype 8 containing the human factor-VII gene | Professor Edward G. Tuddenham | congenital factor VII deficiency |
Granting of the orphan status in the EU |
2015-01-15 | pegylated recombinant arginine deiminase | Designerx Europe Limited (UK) | malignant mesothelioma |
Granting of the orphan status in the EU |
2015-05-13 | recombinant human alkaline phosphatase | AM-Pharma (The Netherlands) | hypophosphatasia |
Granting of the orphan status in the US |
2015-02-12 | ponatinib hydrochloride | Ariad Pharmaceuticals (USA - MA) | gastrointestinal stromal tumours (GIST) | Granting of the orphan status in the US |
2015-08-05 | sodium valproate | Alan Boyd Consultants Ltd (UK) The University of Birmingham (UK) | Wolfram syndrome |
Granting of the orphan status in the US |
2015-06-16 | synthetic signal peptide of human Mucin-1 (amino acids 1-21) | Richardson Associates Regulatory Affairs Ltd (UK)/Vaxil Biotherapeutics (Israel) | plasma cell myeloma/multiple myeloma |
Granting of the orphan status in the US |
2014-11-21 | nintedanib | Boehringer Ingelheim (Germany) | locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) |
Granting of a Market Authorisation in the EU |
2014-10-10 | sulfur hexafluoride lipid microsphere | Bracco Diagnostics (USA - NJ) | patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves |
Granting of a Market Authorisation in the US |
2014-07-08 | tavaborole | Anacor Pharmaceuticals (USA - CA) | onychomycosis of the toenails |
Granting of a Market Authorisation in the US |
2015-07-03 | tasimelteon | Vanda Pharmaceuticals (USA - WA) | non-24- hour sleep-wake disorder (“non-24”) |
Granting of a Market Authorisation in the EU |
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