Clolar is approved for pediatric relapsed or refractory acute lymphocytic leukemia, and Genzyme plans to submit a supplemental new drug application in the second half of 2008 to expand the label into AML

Medarex Inc., of Princeton, N.J., said the FDA allowed two separate investigational new drug applications filed MDX-1342, one for the treatment of chronic lymphocytic leukemia and the other for rheumatoid arthritis...Myriad Genetics Inc., of Salt Lake City, submitted an investigational new drug application to the FDA to begin trials with Vivecon (MPC-9055), for the treatment of AIDS

Can-Fite BioPharma Ltd., of Petach Tikva, Israel, submitted an investigational new drug application to start Phase I testing of CF102, its second pipeline drug, aimed at treating liver diseases, including liver cancer, hepatitis virus infections and liver regeneration...SGX Pharmaceuticals Inc., of San Diego, submitted an investigational new drug application for SGX523, an oral, small-molecule inhibitor of the cMET receptor tyrosine kinase

Results from the Phase III trial are expected to serve as the basis for the firm's new drug application, anticipated in 2008

BioMarin Pharmaceutical Inc., of Novato, Calif., filed an investigational new drug application (IND) with the FDA for phenylketonuria (PKU) treatment PEG-PAL (Poly Ethylene Glycol-Phenylalanine Ammonia Lyase), formerly known as Phenylase

The study was conducted in chronic pancreatitis patients in the U.S., and results will be included in Eurand's rolling new drug application for fast-track Zentase, started in June and expected to complete before the end of this year

GNI Ltd., of Tokyo, said Chinese regulatory authorities cleared its investigational new drug application for F351, a drug that inhibits the overproduction of collagen by liver fibroblasts in liver fibrosis and cirrhosis

Arpida expects to include those data in the new drug application to be filed shortly seeking marketing approval of iclaprim in complicated skin and skin structure infections

Athersys Inc., of Cleveland, said the FDA cleared its investigational new drug application for MultiStem adult stem cells derived from bone marrow...In conjunction with data from Japanese studies, data from the pivotal study of tamibarotene are expected to form the basis of a new drug application, the firm said

Inspiration Biopharmaceuticals, of Laguna Niguel, Calif., filed an investigational new drug application to start clinical trials with IB1001, an intravenous recombinant Factor IX product for the on-demand and prophylactic treatment of the bleeding disorder associated with hemophilia B. Upon FDA clearance, Inspiration intends to initiate Phase I/II trials to test the drug against commercially available Factor IX products

Akesis Pharmaceuticals Inc., of San Diego, said the FDA accepted its investigational new drug application for AKP-020, a vanadium compound, in Type II diabetes...Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, submitted an investigational new drug application for LX2931, an oral drug candidate for rheumatoid arthritis and other autoimmune conditions

Metastatix Inc., of Atlanta, said the FDA accepted its investigational new drug application for MSX-122, a CXCR4 inhibitor, which the company anticipates moving into Phase I testing in solid tumors

Results from the 472-patient trial will form part of the company's new drug application for Flutiform, anticipated in the second half of 2008

The trial, being conducted under an investigational new drug application, is a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers who will receive the drug subcutaneously

The data were included in a new drug application submitted to the FDA on Sept

Innocoll Inc., of Ashburn, Va., said its wholly owned subsidiary, Innocoll Technologies Ltd., filed an investigational new drug application for CollaRx Bupivacaine Topical, to conduct a Phase II trial in chronic skin ulcers

The drug was approved by the FDA in August for use in children ages 3 to 18, and Anesiva plans to file a supplemental new drug application in the first quarter of 2008 for use in adults. (See BioWorld Today, Aug. 20, 2007

PALO-04-07, along with PALO-04-06, a randomized, multicenter Phase III trial focusing on elective outpatient laparoscopic abdominal or gynecological laparoscopic surgery, served as the basis of a supplemental new drug application that was accepted for filing by the FDA July 9

Separately, Accentia said it is working on an investigational new drug application for a pivotal Phase III trial of Revimmune in refractory, relapsing-remitting multiple sclerosis