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BTG PULLS HEPANDRIN NDA
Bio-Technology General Corp. (BTG) has voluntarily withdrawn its new drug application for Hepandrin (oxandrolone) for treating alcoholic hepatitisBioWorld Today | Tuesday, February 22, 1994 -
INSITE'S PILOCARPINE ENTERS SECOND PHASE III TRIAL
InSite said it expects to file a new drug application in 1995BioWorld Today | Friday, February 18, 1994 -
CELL GENESYS LICENSES GENE-ACTIVATED FSH TO AKZO
Ares-Serono filed a new drug application for its product, Gonal-F, in DecemberBioWorld Today | Thursday, February 17, 1994 -
SYMPHONY BEGINS TRIAL OF ACPC
The company also plans to pursue a second indication (and ultimately file a second new drug application) for the use of ACPC in palliating the neuronal effects of strokeBioWorld Today | Wednesday, February 16, 1994 -
PROCYTE HAIR-LOSS DRUG EFFECTIVE IN PRECLINICALS
The company hopes to file an investigational new drug application (IND) and begin clinical trials for all three indications by the end of the year, ProCyte's vice president, Karen Hedine, told BioWorldBioWorld Today | Tuesday, February 15, 1994 -
PROCEPT FINALLY COMPLETES IPO
Procept also hopes to file an investigational new drug application in 1994 for PIC 060, a treatment for psoriasis. -- Karl A. Thiel Associate Editor (c) 1997 American Health ConsultantsBioWorld Today | Monday, February 14, 1994 -
THALIDOMIDE TO ENTER TRIALS FOR HIV
While a new drug application for thalidomide was pending at FDA, the drug was found to be a teratogenBioWorld Today | Tuesday, February 8, 1994 -
MICROCARB MAY DEVELOP HUGHES' ANTIVIRAL COMPOUNDS
MicroCarb would do clinical trials, file new drug applications and market the compoundsBioWorld Today | Thursday, February 3, 1994 -
ANESTA COMPLETES IPO
The company hopes to submit a supplemental new drug application for this indication in 1995BioWorld Today | Thursday, February 3, 1994 -
COURT DENIES GENENTECH'S REQUEST FOR IMPORT BAN ON HGH
BTG filed a new drug application (NDA) for a product in 1987, about six months after Eli Lilly & CoBioWorld Today | Tuesday, February 1, 1994 -
CLINICAL TRIALS
FDA has requested that four Phase III trials be submitted in the company's new drug application (NDABioWorld Today | Thursday, January 27, 1994 -
IMCLONE COMPLETES OFFSHORE PLACEMENT
ImClone is planning to file two investigational new drug applications (INDs) in the first quarter of this year, one of which will be for IL-6BioWorld Today | Thursday, January 20, 1994 -
THERATECH FILES INDS
announced Monday that it has filed investigational new drug applications for its TheraDerm-MTX progestin matrix patch and for an estradiol/progestin combination matrix patchBioWorld Today | Tuesday, January 11, 1994 -
GLYCOMED'S ASTENOSE REDUCES RESTENOSIS IN BABOONS
Glycomed of Alameda, Calif., plans to file an investigational new drug application for Astenose in the first quarter of 1994 for treating vascular restenosis following angioplasty and plans to begin Phase I testing in the second quarterBioWorld Today | Thursday, January 6, 1994 -
FDA ASKS GENSIA FOR MORE DATA
The company submitted a new drug application (NDA) for Protara in December 1992 for the prevention of myocardial infarction and other adverse cardiovascular outcomes in patients undergoing coronary artery bypass graft surgeryBioWorld Today | Thursday, January 6, 1994 -
THERATECH ACQUISITION FORTIFIES PIPELINE
The company plans to file a new drug application for the product in mid-1994BioWorld Today | Thursday, January 6, 1994 -
SEPRACOR TO PURCHASE DRUG MANUFACTURING FACILITY
Furthest in development are S-atenolol (a single-isomer version of Zeneca's Tenormin, which is approved in Denmark) and S-ketoprofen (an investigational new drug application has been filedBioWorld Today | Thursday, January 6, 1994 -
MUCIN-BASED CANCER VACCINE ENTERS CLINICAL TRIALS
Researchers at the Pittsburgh Cancer Institute (PCI) announced last week that they are beginning clinical trials of a novel synthetic peptide cancer vaccine following FDA approval of their investigational new drug application on Dec. 13BioWorld Today | Tuesday, January 4, 1994 -
HEMACARE FILES PHASE III IND FOR IMMUPATH
announced Monday that it has filed an investigational new drug application with FDA to begin Phase III clinical trials of its passive hyperimmune therapeutic ImmupathBioWorld Today | Tuesday, January 4, 1994 -
ZILA TO BUY FIRM WITH DRUG ABSORPTION KNOW-HOW
Zila also has an abbreviated new drug application (ANDA) pending at FDA for OraScan, the first diagnostic for oral cancerBioWorld Today | Tuesday, December 28, 1993
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