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Schering-Plough Corp., (NYSE: SGP) has announced results from the Phase III ENGAGE clinical trial demonstrating that a single injection of corifollitropin alfa, first in the class of sustained follicle stimulants, achieved similar efficacy to recombinant follicle stimulating hormone (rFSH) given once daily for seven days.
Merck (known as MSD outside the United States and Canada) today announced that the European Union has granted marketing approval for a new, single dose regimen of 'Ivemend'® (fosaprepitant) 150 mg. Fosaprepitant is used in adults in combination with other antiemetic medicines for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin (HEC)-based chemotherapy and moderately emetogenic chemotherapy (MEC).
Merck KGaA announced that the European Commission (EC) has granted an approval for three pre-filled, ready-to-use pen injectors for fertility treatment. This "family of pens" is designed for self-administration of the liquid formulations of its three recombinant gonadotropins used in fertility treatments: Gonal-f® (follitropin alfa) 300 IU, 450 IU and 900 IU, Luveris® (lutropin alfa) 450 IU and Ovidrel®/Ovitrelle® 250 micrograms (choriogonadotropin alfa).
The European Commission has launched a public consultation in view of modernising rules on the transparency of Member States’ decisions regarding the pricing and reimbursement of medicines. The consultation invites all interested parties to share their views on the review of Council Directive 89/105/EEC, often referred to as the 'transparency directive'.
Amgen (NASDAQ: AMGN) announced that the European Commission (EC) has granted marketing authorization for XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. This approval of XGEVA applies to all 27 European Union (EU) member states. The EC also granted XGEVA an additional year of data and market exclusivity in the EU since the indication was considered new for denosumab and based on the significant clinical benefit of XGEVA in comparison with existing therapies.
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