British drugmaker AstraZeneca has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its new four-in-one flu vaccine Fluenz Tetra. Fluenz Tetra, a nasally ...
Tags: Astrazeneca, Medicine
Danish pharmaceutical company Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing approval for its NovoEight (turoctocog alfa), ...
Tags: Novo Nordisk, Novoeight
GlaxoSmithKline and biopharmaceutical company Theravance have announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for fluticasone furoate/vilanterol ...
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics' GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle cell ...
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics’ GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle ...
Tags: Orphan Drug, Cell Drug
Biotechnology firm Alexion Pharmaceuticals has secured approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the use of its Soliris (eculizumab) drug to treat pediatric and adult patients with atypical hemolytic ...
Tags: Ahus Treatment, Soliris Drug
The European Medicines Agency (EMA) has received an application from Bayer HealthCare for marketing authorization of its oral multi-kinase inhibitor, regorafenib, for the treatment of patients with gastrointestinal stromal tumors (GlST). ...
Celgene International's oral anti-cancer therapy Pomalidomide has won European Commission approval as treatment for patients with relapsed/refractory multiple myeloma (rrMM), a rare form of blood cancer, in combination with dexamethasone. ...
Tags: Anti-Cancer Therapy
GlaxoSmithKline (GSK) has submitted an application seeking approval from the European Medicines Agency (EMA) of a variation for Votrient (pazopanib). The approval is for additional indication for Votrient as the maintenance treatment of ...
British drugmaker GlaxoSmithKline (GSK) has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its cervical cancer vaccine, Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, ...
Tags: Cervarix, Schedule Application
Swiss drugmaker Novartis has announced that once-daily dual bronchodilator, Ultibro Breezhaler (QVA149), has achieved positive CHMP opinion for the treatment of chronic obstructive pulmonary disease (COPD). Ultibro Breezhaler was ...
Japan-based Takeda Pharma has received positive CHMP opinion for its three new type 2 diabetes therapies from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The therapies include Vipidia ...
Tags: Therapies, CHMP Opinion
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed its opinion for European marketing authorization of Pfizer's Xeljanz (tofacitinib citrate). Xeljanz is a novel, oral Janus kinase ...
Biogen has announced acceptance of marketing applications of Plegridy(peginterferon beta-1a) for review by the US and EU regulatory authorities. Plegridy, a member of the interferon class of treatments, is a pegylated subcutaneous ...
Tags: Biogen, Marketing Applications
The European Medicines Agency (EMA) has accepted Eli Lilly and Company and Boehringer Ingelheim's marketing authorisation application (MAA) for a new insulin glargine product, LY2963016, for review. The application has been filed through ...