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Hollis-Eden Pharmaceuticals has filed an investigational new drug application
with the FDA to begin Phase I clinical trials in human volunteers with NEUMUNE
(HE2100) in the U.S.
The FDA has granted orphan-drug designation to the Institute for OneWorld Health's
paromomycin, an antibiotic intended to treat visceral leishmaniasis (VL).
Arginox Pharmaceuticals has received orphan-drug status from the FDA for Tilarginine
Acetate Injection (TAI) for the treatment of cardiogenic shock (CS).
Barr Pharmaceuticals has received FDA approval to manufacture and market a generic
version of Pfizer's Demulen 1/35-28 (ethynodiol diacetate/ethinyl estradiol
tablets USP, 1 mg/35 mcg) oral contraceptive.
Genentech has announced that a single-masked Phase I/II clinical study of the
investigational drug Lucentis (ranibizumab) met its primary efficacy endpoint
of maintaining vision in patients with wet age-related macular degeneration
(AMD) when used in combination with verteporfin (Visudyne) photodynamic therapy
(PDT).
Idenix Pharmaceuticals has completed enrollment of its Phase IIb clinical trial
of valopicitabine (NM283) with more than 170 treatment refractory hepatitis
C genotype 1 patients.
Adventrx Pharmaceuticals has initiated patient treatment in its international,
300-patient Phase IIb clinical trial to evaluate the safety and efficacy of
the company's lead drug candidate, CoFactor, used in combination with 5-fluorouracil
(5-FU) for the treatment of metastatic colorectal cancer.