original lawsuit triggered the automatic 30-month stay of an FDA decision so Lilly's drug will not be on the market until at least mid-2016. Europe's CMHP issued a positive opinion on Lilly's Abasria MAA on June 27. Post your comment!
insulin Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL). The European Medicines Agency accepted the company's MAA for Toujeo on May 27, 2014. Toujeo will replace Lantus , which loses patent protection in February 2015. Related ticker
The European Medicines Agency grants a renewal of The Medicines Company's ( MDCO ) MAA for Angiox ( bivalirudin ), a direct thrombin inhibitor used as an anticoagulant in adult patients undergoing percutaneous coronary
a Marketing Authorization Application ( MAA ) to the European Medicines Authority ..... the terms of the license agreement, the MAA submission triggers a $5M milestone payment ..... eligible to receive another $15M if the MAA is approved and up to $200M in subsequent
old have the mutation. Kalydeco is currently approved as a treatment for CF in patients six years and older who have one of nine mutations (does not include R117H). The company intends to file an MAA with the EMA in Q3. Post your comment!
min/1.73 m2/yr of patients receiving ERT. The company intends to eventually file a Marketing Authorization Application ( MAA ) with the European Medicines Agency (EMA) contingent on the successful outcome of Study 012. Post your comment!
The European Medicines Agency accepts Merck's ( MRK ) MAA for pembrolizumab , the firm's investigational anti-PD-1 antibody, for the treatment of advanced melanoma. If approved
receiving the combination therapy compared to placebo. Based on these data, Vertex plans to submit an NDA to the FDA and a MAA to Europe's EMA in Q4 2014 for CF patients at least 12 years old who have two copies of the F508del mutation. Post your comment
yields 3.2%. It is a Zacks #3 Rank (Hold) stock. MAA ( MAA ) owns and operates apartment communities in the Sunbelt ..... Effective rent per unit was up 0.3% to $723.40. MAA has a history of steadily raising its dividend. It currently
shareholder-oriented management. We eliminated our positions in real estate investment trust Mid - America Apartment Communities , Inc. ( MAA ), medical appliances and equipment company STERIS Corp. (STE) and turf and agriculture service