Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-11-19 | dantrolene sodium | Eagle Laboratories (USA - CA) | malignant hyperthermia |
Granting of the orphan status in the EU |
2014-11-19 | diaspirin cross-linked haemoglobin | New B Innovation (UK) | hepatocellular carcinoma |
Granting of the orphan status in the EU |
2014-11-19 | humanised IgG1 monoclonal antibody against human eotaxin-2 | CBR Biotech Strategies (Germany) | systemic sclerosis |
Granting of the orphan status in the EU |
2014-11-19 | palovarotene | Medpace Germany (Germany) | fibrodysplasia ossificans progressiva |
Granting of the orphan status in the EU |
2014-11-19 | pentosan polysulfate sodium | Plexcera Therapeutics EU Limited (Ireland) Plexcera Therapeutics (USA - FL) | mucopolysaccharidosis type I | Granting of the orphan status in the EU |
2014-11-19 | Pro-Pro-Thr-Val-Pro-Thr-Arg | Alain TAIEB (France) | xeroderma pigmentosum |
Granting of the orphan status in the EU |
2014-11-19 | siponimod | Novartis (Switzerland) | polymyositis |
Granting of the orphan status in the EU |
2014-10-14 | Genomic Vision (France) | Granting of a patent | ||
2014-10-14 | multidose carbomer gel lubricant | Nicox (France) | dry eye |
Product launch |
2014-10-16 | paroxetine capsules | Noven Pharmaceuticals (USA - FL) | moderate to severe hot flashes associated with menopause |
Granting of a patent |
2014-10-08 | acetic acid, 2-(((1R,2R,4R)-4-amino-2-hydroxycyclohexyl)thio)-, (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyldecahydro-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-3a,9-propano-3ah-cyclopentacycloocten-8-yl ester) | Nabriva Therapeutics (Austria) | community-acquired bacterial pneumonia (CABP) acute bacterial skin and skin structure infections (ABSSSI) |
Granting of a Fast Track status |
2014-10-17 | morphine sulfate and naltrexone hydrochloride | Pfizer (USA - NY) | management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate |
Granting of a Market Authorisation in the US |
2014-10-20 | pediatric hexavalent vaccine | Merck&Co (USA - NJ) Sanofi Pasteur (France) | prevention of diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b (Hib), and hepatitis B |
Acceptation for review of a NDA |
2014-10-23 | PRMT5 Inhibitors | Epizyme (USA - MA) | Granting of a patent | |
2014-10-21 | tafluprost and timolol | Santen GmbH (Germany) | reduction of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta blockers or prostaglandin analogues |
Granting of a Market Authorisation in the EU |
2014-12-19 | conjugated oestrogens and bazedoxifene | Pfizer (USA - NY) | oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom |
Granting of a Market Authorisation in the EU |
2016-10-13 | afamelanotide | Clinuvel UK (UK) Clinuvel (Australia) | erythropoietic protoporphyria |
Submission of a Market Application in the US |
2014-10-07 | pericardial heart valve | Sorin (Italy) | Granting of a Market Authorisation in the US | |
2014-10-15 | transdermal patch | Rhenovia (France) | Granting of a patent | |
2014-10-20 | dabrafenib | GSK (UK) | BRAF mutation positive non-small cell lung cancer |
Granting of the orphan status in the US |
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