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Stock Market & Financial Investment News

News For BMY;PFE;DUF;CG;HLF;CALM From The Last 14 Days
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October 7, 2014
13:59 EDTHLFHerbalife expects some discipline, not shutdown, from FTC, Gasparino says
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08:34 EDTBMYBristol-Myers withdrawing NDA for asunaprevir
Given the rapidly evolving hepatitis C treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue U.S. Food and Drug Administration approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor, which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need. Bristol-Myers says "The dual regimen was developed to meet the distinct need of the Japanese patient population, and we believe this treatment has the potential to play a major role in curing HCV patients in Japan, as well as in other markets where the HCV patient population is similar to Japan. In the EU, daclatasvir was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults. Similarly, we believe that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world. We plan to submit additional data for daclatasvir to the FDA from our ongoing clinical trial program focused on difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant, and patients co-infected with HIV. Next month at the annual meeting of The American Association for the Study of Liver Diseases, we will present new data from several daclatasvir-based regimens. We look forward to bringing daclatasvir to patients in the U.S. and will continue to work closely with the FDA to advance our regulatory application, with the aim of bringing the investigational product to market as quickly as possible."
08:33 EDTBMYBristol-Myers withdrawing NDA for asunaprevir
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07:48 EDTPFEU.S. Chamber of Commerce to hold a discussion
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07:09 EDTCGAlternative asset managers shares attractive, says JPMorgan
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06:13 EDTHLFHerbalife names ex-FTC commissioner to lead compliance group
Herbalife yesterday announced the appointment of Pamela Jones Harbour to the newly created role of SVP, global member compliance and privacy, reporting to Mark Friedman, EVP and general counsel. Harbour will develop and enhance policies and infrastructure that ensure effective education, training and mentoring programs for the nearly 4 million independent Herbalife members worldwide, underpinned by robust and consistent monitoring and enforcement procedures. In addition to her compliance responsibilities, Harbour will also coordinate the companyís global privacy and cyber security efforts. Harbour served as a Commissioner at the Federal Trade Commission from 2003-2010 and a prosecutor at the New York State Attorney Generalís office for 12 years.
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