Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-08-09 | alglucosidase alfa | Genzyme (USA - MA), a Sanofi company (France) | patients with infantile-onset Pompe disease, including patients who are less than 8 years of age |
Granting of a Market Authorisation in the US |
2017-04-18 | ranibizumab | Genentech (USA), a member of Roche Group (Switzerland) | diabetic retinopathy | Granting of a Market Authorisation in the US |
2014-08-10 | bortezomib | Millennium Pharmaceuticals (USA - MA) | retreatment of adult patients with multiple myeloma (MM) who had previously responded to Velcade® therapy and relapsed at least six months following completion of prior Velcade® treatment. |
Granting of a Market Authorisation in the US |
2014-08-10 | combination of a (1,3) beta-glucan and a complement-activating antibody | Biotec Pharmacon (Norway) | Granting of a patent | |
2015-02-10 | albumin-bound form of paclitaxel and gemcitabine | Celgene (USA - NJ) | metastatic pancreatic cancer |
Positive opinion for the granting of a Market Authorisation in the EU |
2017-08-21 | vernakalant IV | Cardiome Pharma (Canada) |
|
Refusal of a Market Autorisation in the US |
2017-02-20 | pacritinib | CTI BioPharma - previously known as Cell Therapeutics (USA - WA) Baxalta (USA - IL) | myelofibrosis | Withdrawal of a market application in the EU |
2014-08-10 | Roseburia hominis | GT Biologics (UK) | ulcerative colitis in pediatric patients age 0 through 16 years |
Granting of the orphan status in the USA |
2014-08-10 | N1,N14,-diethyl-3,12,-dihydroxyhomospermine | Sun BioPharma (USA - FL) | pancreatic cancer |
Granting of a patent |
2014-08-10 | dry extract from Betulae Cortex (birch bark) | Birken AG (Germany) | epidermolysis bullosa |
Granting of the orphan status in the USA |
2014-08-11 | pericardial heart valve | Sorin (Italy) | Granting of a Market Authorisation in the US | |
2014-08-13 | fluticasone propionate 50 mcg spray | GSK (UK) | temporary relief of the symptoms of hay fever or upper respiratory allergies |
Granting of a Market Authorisation in the US |
2014-08-18 | levodopa and carbidopa administered through a pump patch | NeuroDerm (Israel) | Parkinson’s disease |
Granting of a patent |
2014-08-19 | fixed dose artemisinin-based combination therapy | Sanofi (France) PATH | malaria |
Product launch |
2014-08-19 | suvorexant | Merck&Co (USA - NJ) | insomnia |
Granting of a Market Authorisation in the US |
2014-08-19 | tiotropium bromide | Boehringer Ingelheim (Germany) | maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) |
Positive opinion for the granting of a Market Authorisation in the US |
2014-08-20 | RNAi-mediating double-stranded molecules comprising up to 25 base pairs | Alnylam Pharmaceuticals (USA - MA) | Granting of a patent | |
2015-12-16 | insulin glargine (biosimilar version of Lantus®) | Eli Lilly (USA - IN) Boehringer Ingelheim (Germany) | treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above | Product launch |
2016-01-25 | BL-7010 | BiolineRx (Israel) | celiac disease |
Submission of a Market Application in the EU |
2014-08-27 | fluticasone furoate | GSK (UK) | asthma |
Granting of a Market Authorisation in the US |
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