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Number of results: 2790
Date Compound Product name Company Disease Action mechanism Type of Information
2012-03-20 indacaterol (QBAB149) Arcapta Neohaler®/Onbrez Breezhaler® Novartis (Switzerland) once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema long-acting beta2-agonist (LABA) class
2012-03-15 Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD) Sativex® GW Pharmaceuticals (UK) Almirall (Spain)

spasticity due to multiple sclerosis

cannabinol derivative/endocannabinoid modulator. Sativex® is an endocannabinoid modulator made of two actives - THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol). As part of… Granting of a patent
2012-03-15 estradiol valerate and estradiol valerate/dienogest Natazia® Bayer (Germany)

heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus (womb), in women who choose an oral contraceptive  for contraception

Granting of a Market Authorisation in the US
2012-03-15 agalsidase alfa Replagal® Shire (UK - USA)

Fabry disease

Withdrawal of a market application in the US
2012-03-08 Ragweed AIT Ragwitek™ Merck&Co (USA) ALK (Denmark)

ragweed pollen induced allergic rhinitis (hay fever)

Ragwitek® contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by…
2012-03-07 pre-pandemic influenza vaccine composed of purified, inactivated whole influenza virion Vepacel® Baxter (USA)

active immunization in adults 18 years and older (including immunocompromised and chronically ill patients) against the H5N1 subtype of influenza A (A/Vietnam1203/2004), commonly known as bird or avian flu

Vepacel® is a pre-pandemic influenza vaccine manufactured using Baxters proprietary advanced Vero cell technology.Vepacel® is composed of purified, inactivated whole influenza… Positive opinion for the granting of a Market Authorisation in the EU
2012-03-06 belatacept Nulojix® BMS (USA) intended in combination with corticosteroids and a mycophenolic acid for prophylaxis of graft rejection in adults receiving a renal transplant Belatacept is a selective T-cell costimulation blocker. Belatacept binds to CD80 and CD86 on antigen presenting cells. As a result,…
2012-03-02 smallpox vaccine Imvamune® - Imvanex® in Europe. Bavarian Nordic (Denmark) smallpox infection prevention vaccine. The active substance of Imvamune® - Imvanex® is Modified Vaccinia Ankara virus – Bavarian Nordic (MVA-BN) live virus. It…
2012-03-02 rivaroxaban Xarelto® Bayer Healthcare (Germany) Janssen Research & Development (J&J - USA) secondary prevention after an acute coronary syndrome (ACS) This oral anticoagulant is a direct Factor Xa inhibitor. Refusal of a Market Authorisation in the US
2012-03-02 peginesatide peginesatide Takeda Pharmaceutical (Japan) symptomatic anemia associated with chronic kidney disease (CKD) in adult patients on dialysis Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an…
2012-03-02 desmoteplase desmoteplase Lundbeck (Denmark)

acute ischaemic stroke

 

2012-03-02 EV-035 EV-035 Evolva (Switzerland) EV-035 is a bacterial type II topoisomerase inhibitor, belonging to the chemical class of 2-pyridones. EV-035 shows potent broad-spectrum activity,…
2012-02-29 GLPG0778 and its back-up compound GLPG0555 GLPG0778/GSK2586184 and its back-up compound GLPG0555 The compounds are small molecule kinase inhibitors.
2012-02-29 colistimethate sodium Colobreathe® dry powder Forest Laboratories (USA) treatment of cystic fibrosis patients aged 6 years and older with chronic lung infection caused by P.
aeruginosa.
antibiotic
2012-02-23 ulipristal acetate Esmya® Preglem (Switzerland) member of the Richter Group (Hungary)

pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age

The active substance of Esmya® is ulipristal acetate, a selective progesterone receptor modulator, characterised by a tissue-specific partial progesterone antagonist… Granting of a Market Authorisation in the EU
2012-02-21 vandenatib Caprelsa® AstraZeneca (UK)

medullary thyroid cancer in patients with unresectable (non-operable) locally advanced or metastatic disease

kinase inhibitor/tyrosine kinase inhibitor. This tyrosine kinase inhibitor is an antagonist of the vascular endothelial growth factor receptor (VEGFR) and… Granting of a Market Authorisation in the EU
2012-02-17 letermovir AIC246 Aicuris (Germany) prevention of HCMV (human cytomegalovirus) disease Letermovir (AIC246) is an innovative, highly active and specific inhibitor of HCMV. It stems from a novel chemical class (quinazolines)…
2012-02-17 granisetron Sancuso® transdermal patch ProStrakan (UK) prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult.
Granisetron is a highly selective antagonist of 5-hydroxytryptamine (5HT3 receptors). Pharmacological studies have demonstrated that granisetron is effective against nausea…
2012-02-16 Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Menveo® Novartis (Switzerland) prevention of meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y vaccine
2012-02-08 NRP-1 small molecule antagonists NRP-1 small molecule antagonists Ark Therapeutics (UK) cancers Ark has developed the first drug-like small molecule antagonists of VEGF binding to NRP-1 which, in pre-clinical in vivo studies,…