The West Chester, Pa.-based company, which expects to file a new drug application with the FDA by early 1996, has moved to reduce its royalty obligation to Cephalon Clinical Partners L.P
Chiron Corp.'s ophthalmic business, Chiron Vision, said Wednesday it filed a new drug application to market Vitrasert, an intraocular implant that delivers ganciclovir to the eye for treatment of cytomegalovirus (CMV) retinitis
Cephalon, which is developing Myotrophin with Emeryville, Calif.- based Chiron Corp., anticipates filing a new drug application with the FDA by early 1996
Myotrophin is a recombinant human insulin-like growth factor. (See BioWorld Today, June 12-13, p. 1.) Cephalon expects to file its new drug application in the U.S
Phase II studies are expected to begin in the second half of this year, Nisbet said, adding that an investigational new drug application for Phase II U.S
In 1994, DuPont Merck submitted 179 periodic new drug application safety reports, either annually or quarterly, for 170 products and 104 annual investigational new drug applications, producing a total of 283 periodic safety reports
Christoffersen said the collaborators identified a number of ribozymes that potentially could be taken forward, but he declined to discuss the status of the candidates or project timetables on the filing of an investigational new drug application
Under the Hatch-Waxman amendments, pharmaceutical companies seeking to market pioneer drugs must first obtain FDA approval through the filing of a new drug application (NDA
Instead of letting several people be in charge, the center will designate one official for a manufacturer to deal with on a particular issue, similar to the designated official in charge of a new drug application, Zoon said
The deal, including clinical developments costs, is worth about $70 million to Cytel assuming Cylexin is brought to the new drug application stage in the initial indication of acute myocardial infarction, said Deborah Goode, the company's director of business development
The West Chester, Pa.-based company, which expects to file a new drug application with the FDA by early 1996, has moved to reduce its royalty obligation to Cephalon Clinical Partners L.P