The US Food and Drug Administration (FDA) has accepted for review US-based biopharmaceutical firm NPS Pharmaceuticals' supplemental new drug application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection. In the US, Gattex is ...
Tags: FDA, biopharmaceutical
NanoViricides has secured orphan drug designation from the European Medicines Agency (EMA) for its drug candidate DengueCide, for the treatment of dengue and dengue hemorrhagic fever. Dengue fever is a mosquito-borne disease that affects ...
Tags: Nanoviricides Drug
H Lundbeck has expanded its current alliance with Otsuka Pharmaceutical (Otsuka) to include development and commercialization of nalmefene in Japan. Earlier in 2013, nalmefene was approved by the European Medicines Agency (EMA) as the ...
Tags: Lundbeck, Otsuka Pharmaceutical
The US Food and Drug Administration (FDA) has approved Roche's new drug Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy for treatment of patients with chronic lymphocytic leukemia (CLL) who have not previously been ...
Tags: Combination Vaccine, Medicine
Baxter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for approval of Rixubis, recombinant factor IX for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B. ...
Tags: Baxter, European Medicines Agency
Janssen-Cilag (Janssen), a subsidiary of Johnson & Johnson pharmaceutical firm, has submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of once daily oral drug ibrutinib for the ...
Tags: Blood Cancer Medicine, Medicine
British drug maker GlaxoSmithKline (GSK) has received positive opinion from the European Medicines Agency (EMA's) Committee for Medicinal Products for Human Use (CHMP) for additional indication for Synflorix, a pediatric pneumococcal ...
Tags: drug, Pneumonia Indication
The US FDA's Antiviral Drugs Advisory Committee has recommended approval for Medivir's investigational protease inhibitor simeprevir (TMC435) 150mg capsules for the treatment of genotype 1 chronic hepatitis C in adult patients with ...
Tags: Medivir, Hepatitis C Patients
Eli Lilly and Company has received priority review status from the US Food and Drug Administration (FDA) for its ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial ...
Tags: Cancer Drug, FDA Priority
Pfizer has secured European Commission approval to carry out updates to the summary of product characteristics (SmPC) for its pneumococcal conjugate vaccine (PCV) Prevenar 13, regarding its use in certain high-risk populations. Now the ...
Tags: Pfizer, Label Update
Danish pharmaceutical firm Novo Nordisk has received biologics licence application (BLA) approval from the US Food and Drug Administration (FDA) for its recombinant coagulation factor VIII, Novoeight. Novoeight is intended for adults and ...
Tags: Novo Nordisk, Drug
Janssen-Cilag (Janssen) has submitted a marketing authorization application to the European Medicines Agency (EMA) for the approval of a once-daily fixed-dose antiretroviral combination tablet of HIV-1 medicine darunavir with cobicistat. ...
Tags: European Marketing, HIV-1
The European Medicines Agency has launched a new version of the European clinical trials database, EudraCT V9. This new version marks the initial step of a process through which summary clinical trial results will be made publicly ...
Boehringer Ingelheim has submitted a marketing authorisation application to the European Medicines Agency (EMA) for the approval of its oral triple angiokinase inhibitor nintedanib. Nintedanib to be used in combination with docetaxel is ...
Tags: Boehringer Ingelheim, Lung Cancer
Danish pharmaceutical company H. Lundbeck and Japanese drugmaker Otsuka Pharmaceutical have announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for ...