The committee also will discuss Delcath Systems Inc.'s new drug application for the Melblez kit, a drug/device combination that uses the Delcath Hepatic Delivery System to administer Melblez (melphalan) to treat unresectable ocular melanoma that's metastatic to the liver.

Celltrion Inc., of Incheon, South Korea, said it received investigational new drug application approval from the UK's Medicines and Healthcare products Regulatory Agency to start a Phase I trial of CT-P27, an influenza antibody shown to have efficacy for pandemic and seasonal flu strains, including various subtypes of influenza viruses

Gilead Sciences Inc., of Foster City, Calif., said it received complete response letters (CRLs) from the FDA for its new drug applications for elvitegravir and cobicistat to use as part of HIV treatment regimens

R-Tech Ueno, of Tokyo, said it submitted an investigational new drug application to start Phase I/II trials of its recombinant human serum albumin-containing ophthalmic solution, in development for severe dry eye

She cited FDA clearance of the company's investigational new drug application in November 2012 as a key milestone "that opened a lot of doors for us

Theoretically, if the global trial is successful, a new drug application (NDA) can be submitted in China

Eisai transferred the new drug application to Valeant, but retained rights to Targretin outside the U.S

Total Value in 2013: $5,960.77M* Number of Deals in 2013: 93 Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date FEBRUARY Ablynx NV (Ghent, Belgium) Spirogen Ltd. (London) ND Research collaboration to evaluate the potential of a cancer drug conjugate combining Spirogen's cytotoxic drugs, pyrrolobenzodiazepines and associated linker technology, with Nanobodies generated Ablynx will provide access to Nanobodies against an undisclosed target, and Spirogen will

In October 2012, the FDA granted approval of Actavis' abbreviated new drug application

An investigational new drug application filing is anticipated for 2015...Assuming successful completion of the study, NIDA plans to file an investigational new drug application for a final larger study

In our national policy, we do not have a very specific definition about what the new drug application process will be" for those compounds

ActoGeniX NV closed a Series B equity financing round, raising €€10.7 million (US$14 million) to move its ActoBiotics program to the investigational new drug application (IND) stage in a second indication of inflammatory bowel disease (IBD

BIND will develop the Accurin and do the initial screening and will work with AstraZeneca on pre-investigational new drug application activities, then will handle manufacturing during the development phase

plc, of Dublin, Ireland, said the FDA approved a supplemental new drug application to add Chemport Inc...The RAC review is a required step for a product involving gene therapy vectors, and most of the material will be used in the subsequent investigational new drug application filing

plc, of Bedminister, N.J., and Dublin, Ireland, said the FDA accepted its supplemental new drug application for Vascepa (icosapent ethyl) capsules for use as an adjunct to diet in treating high triglycerides...Curemark LLC, of Rye, N.Y., said it will begin filing a new drug application (NDA) for its CM-AT autism treatment following a successful pre-NDA meeting with the FDA

sites. (See BioWorld Today, June 23, 2010.) Top-line results from two Phase III trials in cancer pain are due in 2014 and, pending a positive outcome, are expected to serve as the basis for a new drug application in the U.S., as well as for regulatory submissions in other markets...Ltd., of Tokyo, under the terms of a 2007 deal valued at up to $273 million. (See BioWorld Today, Feb. 15, 2007.) GW also will pursue an MS spasticity indication in the U.S., with an investigational new drug

In our national policy, we do not have a very specific definition about what the new drug application process will be" for those compounds

In our national policy, we do not have a very specific definition about what the new drug application process will be" for those compounds

BIND will develop the Accurin and do the initial screening and will work with AstraZeneca on pre-investigational new drug application activities, then will handle manufacturing during the development phase