Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-12-01 | necuparanib | Momenta Pharmaceuticals (USA - MA) | metastatic pancreatic cancer |
Granting of a Fast Track status |
2016-06-15 | selexipag - 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl)acetamide | Actelion (Switzerland) | pulmonary arterial hypertension (PAH) |
Product launch |
2015-07-13 | gefitinib | AstraZeneca (UK) | advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer |
Granting of a Market Authorisation in the US |
2016-01-15 | secukinumab | Novartis (Switzerland) | psoriatic arthritis |
Granting of a Market Authorisation in the US |
2014-12-24 | diclofenac sodium topical solution | Horizon Pharma (Ireland) | osteoarthritis of the knee |
Patent infringement lawsuit |
2014-12-24 | treprostinil | Medtronic (USA - MN) United Therapeutics (USA - MD) | pulmonary arterial hypertension |
Submission of a Market Application in the US |
2015-03-09 | Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free) | Spectrum Pharmaceuticals (USA - NV) | high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate
|
Acceptation for review of a NDA |
2014-12-23 | travoprost | Alcon (USA - TX), a Novartis company (Switzerland) | decrease of elevated intraocular pressure (IOP) in pediatric patients, aged two months to less than 18 years, with ocular hypertension or pediatric glaucoma |
Granting of a Market Authorisation in the EU |
2015-10-22 | dibotermin alfa | Medtronic BioPharma (The Netherlands) | autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition |
Withdrawal of the product |
2014-11-21 | human protein C | Baxter (USA - IL) | acquired protein C deficiency |
Withdrawal of a market application in the EU |
2017-06-22 | recombinant von Willebrand Factor -vonicog alfa | Baxalta (USA - IL) now Shire (UK - USA) | Von Willebrand disease | Positive opinion for the granting of a Market Authorisation in the EU |
2014-11-18 | Organovo (USA - CA) | Product launch | ||
2016-07-21 | amoxicillin, rifabutin and omeprazole | RedHill Biopharma (Israel) | H. pylori infection |
Granting of a patent |
2014-12-29 | rabeprazole sodium | Eisai (Japan) | prevention of recurrent gastric or duodenal ulcers caused by low-dose aspirin therapy |
Granting of a Market Authorisation in Japan |
2016-10-18 | nanoliposomal irinotecan injection | Merrimack Pharmaceuticals (USA - MA) Shire (UK - USA) | patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy |
Granting of a Market Authorisation in the EU |
2015-01-15 | humanised Fc engineered monoclonal antibody against CD19 | Morphosys (Germany) | diffuse large B-cell lymphoma (DLBCL) |
Granting of the orphan status in the EU |
2015-03-30 | naltrexone HCI / bupropion HCI prolonged release | Orexigen Therapeutics (USA - CA) | adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in obese or overweight adult patients | Granting of a Market Authorisation in the EU |
2014-12-19 | ex-vivo expanded autologous human corneal epithelial cells containing stem cells | Chiesi Farmaceutici (Italy) | moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eyes in adults |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-01-15 | lentiviral vector pseudotyped by the Indiana serotype of the vesicular stomatitis virus G protein encoding an antigen derived from the Tax, HBZ, p12I and p30II HTLV-1 proteins | Theravectys (France) | adult T-cell leukaemia/lymphoma |
Granting of the orphan status in the EU |
2015-01-15 | adenoviral vector serotype 5 containing the vascular endothelial growth factor D isoform (preprocessed short form) from a CMV promoter | Magnus Invention Management Ltd (UK) | placental insufficiency |
Granting of the orphan status in the EU |
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