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 ...
Takeda Pharmaceuticals America (TPA) has signed a contract to supply Omontys (peginesatide) injection to Fresenius Medical Care North America and certain of its affiliates. Omontys (peginesatide) injection is a synthetic, pegylated, ...
Keryx Biopharmaceuticals has reported a net loss of $5.47m, or $0.08 per share, for the third quarter ended 30 September 2012 compared to a net loss of $10.25m, or $0.15 per share, for the third quarter ended 30 September 2011. Operating ...
Tags: Net Loss, Biopharmaceuticals, top-line data
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 European Commission has granted marketing authorization for AMAG Pharmaceuticals' intravenous iron therapy, ferumoxytol, to treat iron deficiency anemia (IDA) in chronic kidney disease (CKD) patients. The marketing authorization is ...
Tags: AMAG Pharmaceuticals, Intravenous Iron Therapy, chronic kidney disease
Takeda Pharmaceutical Company has introduced AMAG's iron deficiency anaemia drug, ferumoxytol, in the Europe. Ferumoxytol is launched as Rienso in Europe and is called as Feraheme in the US. Both the US and European regulatory bodies ...
Tags: Anaemia Drug, adult chronic kidney disease, treatment with Rienso
Telus Health Solutions and Orange have collaborated to provide Calydial remote monitoring solutions to patients with chronic diseases. A team of professionals from Calydial and AGDUC have selected patients living with chronic kidney ...
Tags: Health Solutions, remote monitoring solutions, chronic diseases
The European Medicines Agency (EMA) has accepted to review the Dynavax Technologies Marketing Authorization Application (MAA) for Heplisav. Heplisav is indicated for immunization against infection caused by all known subtypes of hepatitis ...
Takeda Pharmaceuticals USA (TPUSA) and Affymax have announced supply agreement with US Renal Care for Omontys (peginesatide) injection in the US. Under the agreement, US Renal Care will purchase Omontys for use within its organization and ...
Tags: Medicine, Omontys Injection
Cytochroma, a clinical stage specialty pharmaceutical company, has selected OmniComm Systems' eClinical Suite of applications for its two Phase III studies. OmniComm's eClinical Suite, including the EDC, CTMS, Safety, and Coding ...
Tags: Cytochroma, clinical stage, eClinical Suite, patient data, adverse events
Affymax and Takeda Pharmaceutical Company have announced the availability of OMONTYS (peginesatide) injection to treat anemia due to chronic kidney disease (CKD) in adult patients on dialysis. The once-monthly erythropoiesis-stimulating ...
The Centers for Medicare and Medicaid Services (CMS) has granted a unique product reimbursement code (Q-code) for Affymax's Omontys (peginesatide) injection. Omontys is a once-monthly erythropoiesis-stimulating agent (ESA) for anemia ...
Tags: omontys, peginesatide, CKD
Dynavax Technologies has submitted a US Biologics License Application (BLA) to the FDA for HEPLISAV, an investigational adult hepatitis B vaccine. In Phase III trials, HEPLISAV demonstrated higher and earlier protection with fewer ...