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Number of results: 2737
Date Compound Product name Company Disease Action mechanism Type of Information
2012-03-26 R-baclofen R-baclofen Lakeside Regulatory Consulting Services Ltd (UK) fragile X syndrome
2012-03-26 ombrabulin ombrabulin Sanofi (France)

soft tissue sarcoma

Ombrabulin is derived from combretastatin, a natural substance extracted from a bark of a South African tree. It is expected… Granting of the orphan status in the EU
2012-03-26 human anthrax monoclonal antibody human anthrax monoclonal antibody Emergent Sales and Marketing Germany GmbH (Germany) inhalation anthrax disease
2012-03-26 letermovir letermovir AiCuris (Germany) treatment of cytomegalovirus (CMV) disease in patients with impaired cell mediated immunity deemed at risk
2012-03-26 glufosfamide glufosfamide Theradex (Europe) Ltd (UK) pancreatic cancer Glufosfamide is an alkylating agent consisting of iphosphoramide mustard conjugated to glucose that is currently included in clinical studies of…
2012-03-26 darinaparsin darinaparsin Ziopharm Oncology (USA) peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
2012-03-21 azelastine Astepro® Meda (Sweden) allergic rhinitis Astepro® is an antihistamine formulated as a metered-spray solution for intranasal administration. 
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
2012-03-19 rivaroxaban Xarelto® Bayer Healthcare (Germany)

prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) following an acute DVT in adults.

anticoagulant agent/oral direct Factor Xa inhibitor  Granting of a Market Authorisation in the EU
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,…