European Medicines Agency (EMA) has accepted to review Pfizer's marketing authorization application (MAA) for bazedoxifene/conjugated estrogens (BZA/CE). BZA/CE is designed for postmenopausal women with a uterus for the treatment of ...
Tags: bazedoxifene conjugated estrogens, BZA/CE, estrogen deficiency symptoms
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
Janssen-Cilag International has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval to use the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as ...
Tags: investigational drug bedaquiline, multi-drug resistant tuberculosis
Janssen Biotech and Janssen Biologics have submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of Simponi ...
Tags: Simponi, golimumab, active ulcerative colitis, anti-tumor necrosis factor
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 ...
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
EXTEDO, a provider of eRegulatory Affairs solutions, has launched MPDmanager to help life sciences firms comply with new European drug safety regulations. The new solution will support the new XEVMPD submission standard, which goes into ...
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 ...
Affymax has earned $50m development milestone payment from Takeda Pharmaceutical Company for the US approval of OMONTYS (peginesatide) injection. The company has also received another $5m milestone payment, which was triggered by the ...
CSL Behring has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen (immune globulin intravenous [human], 10% liquid for intravenous administration) in Chronic Inflammatory Demyelinating ...
Tags: CSL Behring, Variation Application, Privigen, CIDP
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