- FDA committee recommends approval of OraSure's in-home HIV test
- FDA to review Achillion's HCV drug on fast track basis
- FDA unclear on link between Novartis' MS drug Gilenya, patient deaths
- Stiefel's Fabior foam approved for treating acne
- Ohr Pharmaceutical wins fast track designation for wet AMD product candidate
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
FDA to review Achillion's HCV drug on fast track basis
What's This?
Achillion Pharmaceuticals Inc. received a fast track designation from the Food and Drug Administration for ACH-3102 for use as part of an interferon-free regimen for the treatment of chronic hepatitis C virus (HCV). The drug, a pangenotypic second-generation nonstructural (NS) 5A inhibitor against HCV, is in Phase I testing. Achillion noted that ACH-3102 demonstrated potent inhibition of the NS5A protein across all genotypes of HCV in preclinical studies. The firm sought fast track...
Achillion Pharmaceuticals Inc. received a fast track designation from the Food and Drug Administration for ACH-3102 for use as part of an interferon-free regimen for the treatment of chronic hepatitis C virus (HCV).
The drug, a pangenotypic second-generation nonstructural (NS) 5A inhibitor against HCV, is in Phase I testing. Achillion noted that ACH-3102 demonstrated potent inhibition of the NS5A protein across all genotypes of HCV in preclinical studies.
The firm sought fast track designation for the compound because of its potential for development in a once-daily, interferon-free, fixed-dose combination and its potential to provide improved safety in comparison with the current standard of care. Further, Achillion said ACH-3102 has the potential to deliver potent antiviral activity in vitro against HCV genotypes 1 through 6.
The investigational agent also has a low potential for drug-drug interactions, according to Achillion, and therefore could have greater potential to treat patients with HCV who have comorbidities and those who are co-infected with HIV. For that same reason, it could also prove beneficial in treating patients with HCV before and after they undergo liver transplantation.
Ventrus Biosciences' diltiazem cream improves pain, promotes healing in anal fissures study 
What's This?
Ventrus Biosciences Inc.'s diltiazem hydrochloride topical cream achieved the main endpoint in a Phase III trial of patients with anal fissures by significantly improving pain as compared with placebo.
The study included 465 patients who were randomized to receive diltiazem 4% or 2% cream or placebo. Treatment was applied topically three times daily for eight weeks, followed by a four-week blinded...
Takeda's vedolizumab improves clinical remission in pivotal Crohn's disease trial
What's This?
Takeda Pharmaceutical Co. Ltd.'s vedolizumab significantly improves clinical remission when compared with placebo among patients with Crohn's disease (CD), according to data from a Phase III trial.
The GEMINI II study included 1,115 patients with moderately to severely active CD who had not responded adequately to at least one previous conventional therapy, including tumor necrosis factor-alpha antagonists. The trial...
Merck KGaA reports disappointing results for Erbitux in Phase III colon cancer trial
What's This?
Merck KGaA reported that results of an interim analysis of the European PETACC-8 study failed to show improvement in disease-free survival when Erbitux (cetuximab) was added to standard chemotherapy for the adjuvant treatment of colon cancer in patients with KRAS wild-type tumors.
The Phase III trial included 2,559 patients with stage III colon cancer that...
CSL Behring starts Phase I/II trial of treatment candidate for hereditary angioedema
What's This?
CSL Behring began a Phase I/II study to investigate a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in adults with hereditary angioedema (HAE) type I or type II.
The open-label trial is being conducted as part of the COMPACT program, which is assessing optimal management in preventing angioedema with low-volume, subcutaneous C1-INH replacement therapy.
After an initial IV injection...
