Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-04-24 | antihemophilic factor recombinant | Baxter (USA - IL) | hemophilia A |
Granting of a Market Authorisation in the US |
2014-04-28 | T-cell receptors against the tumor associated antigen tyrosinase | Medigene (Germany) | Granting of a patent | |
2014-04-29 | delta-9-Tetrahydro-cannabinol (THC) and cannabidiol (CBD) | GW Pharmaceuticals (UK) | cancer pain |
Granting of a patent |
2014-05-05 | Staccato® loxapine | Teva Pharmaceuticals (Israel) | rapid control of mild to moderate agitation in adults with schizophrenia or bipolar disorder |
|
2014-05-06 | Qiagen (Germany - the Netherlands) | detection of Clostridium difficile infection |
Granting of a Market Authorisation in the US | |
2015-07-23 | simeprevir and sofosbuvir | Janssen (J&J - USA) | genotype 1 chronic hepatitis C (HCV) in adult treatment-naïve patients with advanced fibrosis and null responders with all stages of liver fibrosis |
Submission of an sNDA |
2014-05-09 | vorapaxar | Merck&Co (USA - NJ) | reduction of the risk of heart attack, stroke, cardiovascular death, and of need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs reduction of atherothrombotic events in adult patients with a history of myocardial infarction (MI) |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-09-24 | carbidopa-levodopa | Impax Pharmaceuticals (USA -CA) | Parkinson’s disease |
Positive opinion for the granting of a Market Authorisation in the EU |
2014-05-13 | allopregnanolone | Sage Therapeutics (USA - MA) | status epilepticus |
Granting of a Fast Track status |
2015-07-23 | ceftolozane/tazobactam | Cubist Pharmaceuticals (USA - MA) Merck & Co (USA - NJ) | complicated urinary tract infections (cUTI) acute pyelonephritis complicated intra-abdominal infections (cIAI) |
Positive opinion for the granting of a Market Authorisation in the EU |
2014-05-14 | antihemophilic factor VIII | Bayer HealthCare (Germany) | routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A |
Granting of a Market Authorisation in the US |
2016-11-22 | nivolumab | BMS (USA - NY) | Hodgkin lymphoma Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab vedotin |
Granting of a Market Authorisation in the EU |
2014-05-15 | HDAC6 inhibitors | Kancera (Sweden) | cancer |
|
2016-05-26 | adalimumab | Abbvie (USA - IL) | non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis |
Positive opinion for the granting of a Market Authorisation in the EU |
2018-01-03 | lifitegrast | Shire (UK-USA) | dry eye disease | Granting of a Market Authorisation in Canada |
2014-07-04 | 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2- methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide | Vertex Pharmaceuticals (USA - MA) | cystic fibrosis | Granting of the orphan status in the EU |
2014-05-20 | mixture of two adeno-associated viral vectors of serotype 8 containing the 5’-half sequence of human ABCA4 gene and the 3’-half sequence of human ABCA4 gene for treatment of Stargardt\'s disease. | Fondazione Telethon (Italy) | Stargardt\'s disease |
Granting of the orphan status in the EU |
2014-05-20 | mixture of two adeno-associated viral vectors serotype 8 containing the 5’-half sequence of human MYO7A gene and the 3’-half sequence of human MYO7A gene | Fondazione Telethon (Italy) | Usher syndrome | Granting of the orphan status in the EU |
2014-11-05 | adeno-associated viral vector serotype 2 containing the human REP1 (Rab escort protein 1) gene | NightstaRx (UK) | choroideremia |
Granting of the orphan status in the US |
2014-07-04 | afamelanotide | Clinuvel UK (UK) Clinuvel (Australia) | familial benign chronic pemphigus (Hailey-Hailey disease) |
Granting of the orphan status in the EU |
© 2024 Biopharmanalyses - Powered by Samacom+