With the cost of clinical trials climbing, the FDA is worried about its ability to obtain sufficient information to make determinations about safety and efficacy claims when examining new drug applications and biologics license applications

Other candidates currently undergoing tests required for investigational new drug applications with the FDA include an undisclosed iBioLaunch-produced monoclonal antibody and vaccines for anthrax, malaria and yellow fever

Such products should only be made by an FDA-registered drug manufacturer under an approved new drug application, she said

United Therapeutics Corp., of Silver Spring, Md., said it received a second complete response letter (CRL) from the FDA, declining to approve its new drug application (NDA) for treprostinil diolamine extended-release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension (PAH...Vanda Pharmaceuticals Inc., of Washington, completed a pre-new drug application meeting with the FDA to discuss a regulatory path for tasimelteon for non-24-hour disorder, a rare disorder of

Launch of Actavis' product is contingent upon the company receiving final approval from the FDA on its abbreviated new drug application (ANDA) for generic Crestor...Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, and Eli Lilly and Co., of Indianapolis, submitted a new drug application for sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for Type II diabetes in adults

Based on the findings, Trius plans to file a new drug application for tedizolid and to initiate a Phase III study of tedizolid in patients with severe pneumonia during the second half of the year. (See BioWorld Today, Feb. 14, 2013

pSivida Corp., of Watertown, Mass., said licensee Alimera Sciences Inc., of Atlanta, disclosed plans to resubmit a new drug application for Iluvien (fluocinolone acetonide intravitreal implant) in diabetic macular edema (DME) by the end of March

Company (Location) University/ Nonprofit Type of Agreement Product Area Details Date DECEMBER Biogen Idec Inc. (Weston, Mass.) Several leading academic research centers Research consortium Created a research consortium in collaboration with several leading academic research centers aimed at leveraging a range of scientific techniques and disciplines to identify new approaches to treating amyotrophic lateral sclerosis Each participating lab will undertake a three-year research project, and

Proceeds from the IPO are expected to advance Enanta's earlier-stage pipeline programs, including its cyclophilin inhibitor, EDP-546, set to start investigational new drug application-enabling studies

Acorda plans to submit a new drug application under the 505(b)(2) pathway this year

The company is planning to submit an investigational new drug application for its lead PDE7 inhibitor, OMS527, with the intention of beginning human trials later in 2013

It has steadfastly continued with plans to seek approval in the U.S., proactively including a comprehensive risk evaluation and mitigation strategies plan with its planned new drug application submission

The AzaSite Plus and DexaSite Phase III programs also are expected to report data this year, and InSite is not averse to filing three new drug applications on its own

Titan submitted its new drug application for Probuphine to the FDA in October 2012 under the 505(b)(2) pathway

QRxPharma Ltd., of Sydney, Australia, said the FDA set a PDUFA date of Aug. 26 for the resubmitted new drug application seeking approval of Moxduo, an immediate-release dual opioid pain therapy that combines morphine and oxycodone

Slow enrollment and new data generated under a compassionate-use investigational new drug application led to the closure of the trial in January 2009

The company submitted a supplemental new drug application in December to expand the use to all adults with IDA who have failed or could not tolerate oral iron treatment. (See BioWorld Today, July 1, 2009

Spectrum is assuming responsibility for the ongoing trial and will be responsible for filing a new drug application, expected in the first half of 2014...The company anticipates that 1 kg will be sufficient to complete the upcoming investigational new drug application-enabling animal toxicity studies and Phase I trials

The company has also submitted new drug applications to the FDA for canagliflozin and for the fixed-dose combination therapy