Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-09-16 | silibinin-C-2\',3-dihydrogensuccinate, disodium salt | Rottapharm | amatoxin poisoning, which includes the prevention and treatment of amatoxin induced hepatic failure |
Granting of the orphan status in the US |
2014-12-09 | naloxegol | AstraZeneca (UK) | opioid-induced constipation (OIC) for adult patients 18 years and older, including patients with inadequate response to laxatives |
Granting of a Market Authorisation in the EU |
2015-03-25 | aflibercept | Regeneron Pharmaceuticals (USA - NY) Bayer Healthcare (Germany) | diabetic retinopathy in patients with diabetic macular edema (DME) |
Granting of a Market Authorisation in the US |
2014-09-18 | paclitaxel for injection | Oasmia Pharmaceutical (Sweden) | canine mammary carcinoma squamous cell carcinoma |
Granting of a Market Authorisation in the US |
2014-09-22 | OPKO Health (USA - FL) | prostate cancer |
Product launch | |
2015-01-30 | lisdexamfetamine dimesylate | Shire (UK - USA) | binge eating disorder |
Granting of a Market Authorisation in the US |
2014-11-25 | dulaglutide | Eli Lilly (USA - IN) | type 2 diabetes |
Granting of a Market Authorisation in the EU |
2014-09-30 | infliximab | Epirus Biopharmaceuticals (USA - MA) | Granting of a Market Authorisation in the US | |
2014-10-03 | Ariad Pharmaceuticals (USA -MA) | patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib |
Granting of the Breakthrough Therapy status | |
2016-02-25 | nivolumab | BMS (USA - NY) | non-small cell lung cancer |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-10-10 | oral thin film formulation of rizatriptan | IntelGenx (Canada) Redhill Biopharma (Israel) | acute migraines |
Granting of a Market Authorisation in the EU |
2015-11-26 | human (allogeneic) bone marrow derived mesenchymal stem cells | JCR Pharmaceuticals (Japan) Mesoblast (Australia - USA - NY) | acute graft versus host disease (GVHD) |
Reimbursement |
2014-12-16 | pasireotide long-acting release | Novartis (Switzerland) | acromegaly |
Granting of a Market Authorisation in the US |
2014-10-04 | fully automated, real-time PCR based molecular diagnostics system | Biocartis (Belgium) | melanoma |
Product launch |
2015-04-10 | interferon gamma-1b | Horizon Pharma (Ireland) | Friedreich's ataxia |
Granting of a Fast Track status |
2014-10-06 | Argen-X (The Netherlands-Belgium) | Granting of a patent | ||
2014-10-07 | nitric oxide | Advanced Inhalation Therapies (Israel) | cystic fibrosis |
Granting of the orphan status in the US |
2014-12-18 | heat killed whole cell mycobacterium obuense | Immodulon Therapeutics (UK) | pancreatic cancer |
Granting of the orphan status in the EU |
2014-10-07 | TLR-7 agonist | Telormedix (Switzerland) | bladder cancer |
Granting of a patent |
2016-04-01 | adalimumab | Abbvie (USA - IL) | pediatric Crohn's disease patients 6 years of age and older when certain other treatments have not worked well enough |
Positive opinion for the granting of a Market Authorisation in the EU |
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