Takeda Pharmaceutical Company and NPS Pharmaceuticals have announced positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Teduglutide (Revestive) for patients with short bowel syndrome (SBS). Teduglutide, ...
Tags: short bowel syndrome, teduglutide, glucagon-like peptide 2
Sosei Group Corporation,Japan, has received a positive opinion for its Seebri Breezhaler (glycopyrronium bromide/NVA237),a type of bronchodilator, from European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). ...
Tags: Seebri Breezhaler, bronchodilator, CHMP, Positive Chmp Opinion
Novartis has planned to update the Rasilez's labelling to include contraindications against combined use with a number of products. The company will follow the advice of the EMA's Committee for Medicinal Products for Human Use (CHMP) in ...
Tags: Novartis, CHMP, Rasilez's labelling
Pfizer has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for crizotinib to treat adults with previously treated anaplastic lymphoma kinase (ALK)-positive ...
Tags: Pfizer, CHMP, anaplastic lymphoma kinase
Bexsero, Novartis' Meningococcal Group B Vaccine, has won a positive opinion from European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion indicates the use of the broad coverage vaccine in ...
Pfizer has received positive opinion from the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency for the marketing authorization of axitinib to treat patients with advanced renal cell carcinoma. The European ...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Astellas Pharma Europe's Betmigatm (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency ...
Tags: symptomatic treatment of urgency, pharmaceutical product
Novartis' Exjade has received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Exjade is used to treat chronic iron overload requiring chelation therapy when ...
Tags: Medicinal Products, iron overload, CHMP recommendation
Novartis has announced a label change for Gilenya in the US, to include cardiovascular monitoring, while the EMA has called for similar changes in Europe. The US label changes are the result of discussions with the FDA, following ...
Ferrer Internacional has decided to withdraw the marketing authorisation application (MAA) for Egrifta (tesamorelin) 2mg, powder for solution for injection in Europe. Ferrer formally notified the European Medicines Agency of its decision. ...
Tags: DME, healthcare products, pSivida
AET BioTech and BioXpress Therapeutics have signed a research deal for the development of a biosimilar version of the TNF inhibitor MAb Adalimumab. Under the agreement, both the companies will be responsible for the development, ...
Tags: AET BioTech, BioXpress Therapeutics, TNF Inhibitor, research deal
The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AMAG Pharmaceuticals' ferumoxytol, an iron deficiency anemia (IDA) therapy. The intravenous (IV) iron therapy, indicated for the treatment of ...
Tags: AMAG Pharmaceuticals, iron deficiency anemia(IDA)therapy
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended SkyePharma's flutiform (fluticasone propionate/formoterol fumarate) for European marketing approval. Flutiform is a ...
Tags: Skyepharma Flutiform, SkyePharma, long-acting beta-agonist
European Medicines Agency's (EMA) Committee for Orphan Medicinal Products has announced positive opinion for granting orphan disease designation to Aspireo Pharmaceuticals' Somatoprim for the treatment of acromegaly. Somatoprim, the ...
The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has recommended Orphan Drug Designation (ODD) for Erytech Pharma's investigational product Enhoxy. The drug, which is used to treat sickle cell ...
Tags: orphan drug designation, Erytech product, debilitating disease