Endocyte and its Big Pharma partner Merck won the support of the Committee for Medicinal Products for Human Use at the EMA for conditional approval of the biotech's lead drug in Europe, winning over regulators with mid-stage data demonstrating that vintafolide successfully delayed disease progression for ovarian cancer.
A European Union regulator has recommended approval of 11 new drugs for a range of diseases such as HIV, breast cancer and diabetes. And the nods could lead to final approvals from the European Commission in the coming months.
Swiss pharma giant Novartis has earned an endorsement from the European Committee for Medicinal Products for Human Use for it once-daily Ultibro Breezhaler to treat chronic obstructive pulmonary disease.
Two drugmakers reported regulatory victories for therapies in the important European market. A European Medicines Agency committee endorsed approval of Celgene's ($CELG) pomalidomide for multiple myeloma and Aegerion's ($AEGR) Lojuxta for a genetic cause of high cholesterol called homozygous familial hypercholesterolemia.
Arena Pharmaceuticals pulled the plug on its application for approval of the obesity drug Belviq with European regulators, another blow to the commercial and regulatory effort behind the treatment. The San Diego-based biotech revealed the decision to withdraw the app in its first-quarter financial report late Thursday afternoon.
European authorities have battered expectations for Pfizer's rheumatoid arthritis pill Xeljanz, spurning the drug giant's request for approval over concerns about the risk-benefit profile. The surprise rejection cools the company's run of regulatory success, which included 5 FDA approvals in 2012.
Shares of Italy's Gentium plunged more than 40% this morning after the biotech announced a fresh round of woes with regulators--this time in Europe--for its vascular drug defibrotide.
Santhera Pharmaceuticals suffered a setback today with the rejection of its key experimental drug for a genetic cause of blindness. European Union reviewers denied the Swiss specialty pharma their support for approval of Raxone over concerns about the small number of patients studied during clinical development.
Sanofi ($SNY) made progress today on the product-replacement front. The French drug giant snagged endorsements from European Union regulators that pave the way to potential approvals of new drugs for diabetes and cancer, coming at a time when the company needs new products as older meds lose patent protection.
The Committee for Medicinal Products for Human use nixed Vivus' application for approval, citing worries about Qsiva's safety and probable off-label use.