The company will not submit the new drug application until near the end of 2014, a wait that caused some chagrin among interrogators

Oramed Pharmaceuticals Inc., of Jerusalem, submitted an investigational new drug application (IND) to the FDA for its oral insulin candidate, ORMD-0801 , in response to FDA feedback on its initial IND filing Dec. 31, 2012

Merck filed a new drug application with the FDA for a related compound, Suvorexant, in the fall of 2012

Boston Therapeutics Inc., of Manchester, N.H., said it requested an investigational new drug application meeting with the FDA for clinical testing of PAZ320, a nonsystemic chewable drug designed to reduce the elevation of postprandial glucose or postmeal blood sugar in patients with Type II diabetes...StemCells Inc., of Newark, Calif., said it entered an agreement with the California Institute for Regenerative Medicine (CIRM), under which CIRM will provide about $19.3 million to help fund

Synergy submitted an investigational new drug application to the FDA in September 2012

Inc., of Whitehouse Station, N.J., said its new drug application for a tablet formulation of antifungal agent Noxafil (posaconazole) was accepted for review by the FDA

The open-label study under an investigational new drug application is designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adults with relapsed/refractory AML

From said the company is "probably about 12 months away" from filing an investigational new drug application for that product...The next step for EGP-437 is a second Phase III study to allow filing of a new drug application

Gilead Sciences Inc., of Foster City, Calif., submitted a new drug application (NDA) to the FDA for sofosbuvir, its once-daily oral nucleotide analogue to treat chronic hepatitis C virus (HCV) infection...Sunshine Biopharma Inc., of Montreal, said it completed several investigational new drug application-enabling studies, including one in which the cytotoxic activity of Adva-27a, its lead oncology candidate, was measured in the HMEC (noncancerous human mammary epithielial) cell line

Erytech Pharma SA, of Lyon, France, said it received clearance of its investigational new drug application for a Phase I trial of Eryasp (L-asparagainase-loaded erythrocytes) in patients 40 years and older with newly diagnosed acute lymphoblastic leukemia

Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said the FDA accepted for filing and granted priority review to its new drug application (NDA) for oral investigational compound riociguat in chronic thromboembolic pulmonary hypertension (CTEPH) that is inoperable or persistent or recurrent CTEPH after pulmonary endarterectomy and pulmonary arterial hypertension

Receptos is moving the drug into Phase II testing for orphan disease eosinophilic esophagitis (EoE), with a pre-investigational new drug application (IND) meeting with the FDA this year and an IND filing expected in the first half of 2014

Noven Pharmaceuticals Inc., of Miami, said it confirmed that it filed an abbreviated new drug application seeking approval to market its rivastigmine transdermal system in 4.6 mg/24 hours and 9.5 mg/24 hours dosage strengths

VG Life Sciences Inc., of San Marino, Calif., disclosed positive results from stage 2 of its pre-investigational new drug application Phase I study to test tolerability and toxicity in patients with advanced-stage solid tumors

Net proceeds will be used to cover costs related to the new drug application for CompleoTRT, making a milestone payment for CompleoTRT, manufacturing scale-up for CompleoTRT and Tefina clinical trials

In 2010, the company attracted up to $3.3 million in funding from the Leukemia & Lymphoma Society through its therapy acceleration program, supporting remaining preclinical studies for SHP-141 and enabling the filing of an investigational new drug application and a first-in-man randomized Phase Ib study in CTCL

Aquinox is evaluating analogues that may lend themselves to different routes of administration, and is pushing the follow-on products into studies that could enable investigational new drug applications

Tris Pharma Inc., of Monmouth Junction, N.J., said the FDA approved its new drug application for Karbinal ER (carbinoxamine maleate) extended-release oral suspension, a sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children 2 years and older

Erytech Pharma SA, of Lyon, France, said it received clearance of its investigational new drug application for a Phase I trial of Eryasp (L-asparagainase-loaded erythrocytes) in patients 40 years and older with newly diagnosed acute lymphoblastic leukemia