Takeda Pharmaceutical Company has submitted marketing authorisation application (MAA) seeking approval from the European Medicines Agency (EMA) for its investigational, gut-selective humanized monoclonal antibody for the treatment of adults ...
Tags: Takeda, IBD Disease Drug, MAA, EMA
The European Commission has asked the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) to evaluate the risk for consumers arising from the presence of residues of anti-inflammatory drug phenylbutazone in ...
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Novartis Ilaris for use in acute gouty arthritis patients who are not suitable for current treatments. The only ...
Tags: Medicinal Products, therapies, treatments
Biogen Idec and Elan are seeking approvals from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for first-line use of Tysabri (natalizumab) in anti-JCV antibody negative patients with multiple sclerosis (MS). ...
Edison Pharmaceuticals has started a phase 2B study, which will investigate new treatments for Friedreich's ataxia. The trial is entitled Safety and Efficacy Study of EPI-743 on Visual Function in Patients with Friedreich's Ataxia. It is ...
Tags: Edison Pharmaceuticals, disease severity, neuromuscular function
FINOX Biotech has submitted the Marketing Authorisation Application (MAA) for its biosimilar recombinant Follicle Stimulating Hormone (r-FSH) BEMFOLA to the European Medicines Agency. The submission was based on a comprehensive clinical ...
Tags: FINOX Biotech, Marketing Authorisation Application, Medicines, healthcare
EMC said today it has agreed to buy privately-held start-up Silver Tail Systems, a vendor of real-time web session intelligence and behavioural analysis. EMC plans to use the purchase to beef up its RSA security division in the rapidly ...
Tags: EMC, Silver Tail, web intelligence, Silver Tail Systems
The Medicines Company has agreed to buy Incline Therapeutics for an upfront payment of $185m. Incline, a hospital-focused specialty pharmaceutical company, produces a needleless patient-controlled IONSYS (fentanyl iontophoretic ...
Tags: Medicines Company, Incline Therapeutics, pharmaceutical company
Ipsen and Inspiration Biopharmaceuticals have announced FDA Fast Track status to an intravenous recombinant porcine factor VIII, OBI-1, for acquired hemophilia A therapy. The drug candidate is being studied to treat acquired hemophilia A ...
Tags: FDA, fast track status, drug candidate
Savient Pharmaceuticals's Krystexxa (pegloticase) has received positive opinion recommending approval of a marketing authorization from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) following ...
Tags: Savient Krystexxa, positive CHMP, EMA
The Environment and Water Resources Ministry has issued instructions to government agencies to halt a planned$20 million Tobago House of Assembly project on the Charlotteville beachfront until it receives proper environmental clearance. ...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional approval for Takeda Pharmaceuticals and Millennium adcetris (brentuximab vedotin) in Europe. If the CHMP ...
Tags: CHMP, refractory CD30 positive Hodgkin lymphoma, sALCL
US based Ariad Pharmaceuticals has submitted New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib for the approval of US Food and Drug Administration (FDA). Ponatinib is indicated for patients with resistant or ...
Tags: BCR-ABL inhibitor, CML, Ph+ALL
The European Commission has granted conditional marketing authorization for Pfizer’s Xalkori (crizotinib) to treat anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) in the European Union (EU). ...
Tags: Xalkori, crizotinib, anaplastic lymphoma kinase, ALK
Genzyme, a Sanofi company, has submitted a supplemental biologics license application (sBLA) to the FDA and marketing authorization application (MAA) to EMA for Lemtrada to treat relapsing multiple sclerosis (RMS). In collaboration with ...
Tags: sBLA, relapsing multiple sclerosis, RMS