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November 12, 2012
15:33 EDTBMYBristol-Myers reports data for studies of Hep C compounds
Bristol-Myers Squibb announced for the first time interim results from the global, D-LITE Phase IIb study, in which a 24-week regimen combining the investigational compound Peginterferon lambda-1a with the investigational direct-acting antiviral daclatasvir and ribavirin, achieved sustained virologic response 12 weeks post-treatment in 93%, or 13/14, of treatment-naïve, genotype 1b chronic hepatitis C patients who achieved a protocol-defined response. The SVR12 rate for all genotype 1 infected patients in the Lambda/RBV/DCV group was 76%, or 28/37. These study findings were presented in a late breaker presentation at the American Association for the Study of Liver Diseases congress in Boston. The company also presented SVR4 results from the D-LITE Japanese sub-study, where all subjects were infected with HCV genotype 1b and SVR12 was 100%. SVR results from the EMERGE Phase IIb study of Lambda versus alfa interferon in treatment-naïve genotype 1 or 4 patients were also presented. In the D-LITE study, adverse events were mostly low grade and self-limiting. In the Lambda/RBV/DCV treatment group, only one of 37 patients experienced a serious adverse event, breast cancer, which was unrelated to study drug. The lead investigator said, “Treatment with lambda interferon combined with daclatasvir and ribavirin achieved high rates of sustained virologic response, and the data support further study of regimens using lambda interferon to address the medical needs of hepatitis C patients who cannot use alfa interferons.”
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April 23, 2014
07:37 EDTBMYPeregrine announces investigator-sponsored combination trial with Bristol-Myers
Peregrine Pharmaceuticals (PPHM) announced the opening of an investigator-sponsored trial, or IST, of its investigational immunotherapy bavituximab in combination with Bristol-Myers Squibb's (BMY) ipilimumab, for the treatment of advanced melanoma. Bavituximab is an upstream immune checkpoint inhibitor that targets phosphatidylserine, or PS, a highly immunosuppressive molecule exposed on cells that line tumor blood vessels and tumor cells. Preclinical data in a model of melanoma demonstrate that the combination of a bavituximab equivalent and ipilimumab yield enhanced anti-tumor activity compared to ipilimumab alone. The trial is being conducted at the University of Texas Southwestern Medical Center, Dallas, and led by Arthur E. Frankel, M.D., Associate Professor of Internal Medicine at the Simmons Comprehensive Cancer Center. Bavituximab, Peregrine's lead immuno-oncology candidate, is being evaluated in second-line non-small cell lung cancer, as part of the SUNRISE pivotal Phase III clinical trial.
06:16 EDTBMYPharmaceutical companies narrowing focus, WSJ reports
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April 22, 2014
19:03 EDTBMY Bristol-Myers and Samsung BioLogics to increase scope of existing agreement
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14:47 EDTBMYOnglyza, Kombiglyze XR get Paragraph IV patent challenges
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April 21, 2014
07:21 EDTBMYFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
April 19, 2014
11:12 EDTBMYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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April 15, 2014
08:23 EDTBMYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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08:19 EDTBMYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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06:32 EDTBMYPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
08:15 EDTBMYBristol-Myers submits NDA for Reyataz-cobicistat combo for HIV-1
Bristol-Myers Squibb (BMY) announced the submission of a new drug application, or NDA, on April 4 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Bristol-Myers Squibb is seeking approval of the fixed-dose combination tablet for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet. Cobicistat is being developed by Gilead Sciences (GILD). Under the terms of a previously announced agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the atazanavir sulfate and cobicistat fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
April 10, 2014
07:04 EDTBMYBristol-Myers presents Phase III data on all-oral Daclatasvir and Asunaprevir
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