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Drugs in Development / Clinical Trials—Updated October 13, 2014
Thursday, November 27, 2014
Professor Edward Gane was one of more than a dozen researchers and scholars awarded medals by the Royal Society of New Zealand at a ceremony in Wellington last night.
Professor Gane, from Auckland City Hospital and the Auckland District Health Board, received the Liley Medal for his work on an improved treatment for hepatitis C, which is a major cause of liver failure in New Zealand.
Community pharmacists have the potential to screen at-risk groups for hepatitis C and could play a key role in helping to improve liver disease services in primary care, according to the conclusions of a commission set up to investigate the impact of the disease.
Writing in The Lancet (online, 27 November 2014), the group of leading doctors and medical scientists who made up the commission argue that screening for hepatitis C in primary care is cost-effective.
People at risk of the disease could be screened in community pharmacies that already offer needle exchange or methadone services, suggests the group, led by Roger Williams, director of the institute of hepatology at Foundation for Liver Research, London.
Wednesday, November 26, 2014
Want to know what that number is?
In this part of our series “At the Crossroads: The Rise of Hepatitis C and The Fight To Stop It,” we'll tell you that - and more. We go beyond the high price of new hepatitis C drugs to ask: how much is too much? And what the heck is a "quality adjusted life year" anyway?
Listen to the podcast here...
Presenting the Safe Point San Diego Clean Syringe Exchange Program Annual Report for fiscal year 2014 Dunford then asked Council members to imagine the stack of 2.5 million dirty needles: “Put that at Petco Park and see what kind of pile you’d be looking at.”
Dunford told members of the Public Safety & Livable Neighborhoods Committee the program has taken in 405,416 dirty needles just in the last fiscal year. He said the program has collected 276,958 more syringes than clean ones distributed to drug addicts.
Bristol-Myers Squibb Receives Complete Response Letter from U.S. Food and Drug Administration for Daclatasvir, an Investigational Treatment for Hepatitis C
The initial daclatasvir NDA submitted to the FDA focused on its use in combination with asunaprevir, an NS3/4A protease inhibitor. Given the withdrawal of asunaprevir by Bristol-Myers Squibb in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV. Bristol-Myers Squibb is in discussions with the FDA about the scope of these data.
“Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need in this disease area,” said Francis Cuss, Executive Vice President and Chief Scientific Officer, R&D, Bristol-Myers Squibb. “Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the U.S. as quickly as possible.”
Ongoing Daclatasvir Clinical Development
Bristol-Myers Squibb is dedicated to the ongoing clinical development program for daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need. The company continues to progress its daclatasvir clinical trial program focused on difficult-to-treat patients, including pre- and post-liver transplant (ALLY-1), HCV patients co-infected with HIV (ALLY-2) and patients with genotype 3 (ALLY-3). The Phase 3 UNITY studies investigating Bristol-Myers Squibb’s investigational all-oral fixed-dose-combination DCV-TRIO regimen (daclatasvir/asunaprevir/beclabuvir) are also ongoing and include study populations of non-cirrhotic naïve, cirrhotic naïve and previously treated patients.
Bristol-Myers said it had initially sought permission from the U.S. Food and Drug Administration to market the drug, a so-called NS5A inhibitor, in combination with asunaprevir, one of the New York-based company's experimental medicines.
But Bristol-Myers abandoned its U.S. marketing application for asunaprevir in October because of potential competition from more potent drugs, leaving the FDA without data to gauge the effectiveness of daclatasvir as part of a combination regimen.