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August 20, 2014
08:02 EDTBMY, CELGBristol-Myers, Celgene enter collaboration agreement for OPDIVO, ABRAXANE
Bristol-Myers Squibb (BMY) and Celgene (CELG) announced the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, OPDIVO and Celgene’s nab technology-based chemotherapy ABRAXANE in a Phase I study. Multiple tumor types will be explored in the study including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer. The proprietary name OPDIVO has been proposed in the U.S. and other countries, but remains subject to health authority approval. The study, which is expected to begin in 4Q14, will be conducted by Celgene. Patients with HER-2 negative breast cancer will be treated with ABRAXANE and OPDIVO, patients with NSCLC will be treated with the combination of ABRAXANE, carboplatin and OPDIVO, and patients with pancreatic adenocarcinoma will be treated with ABRAXANE, gemcitabine and OPDIVO. Additional details of the collaboration were not disclosed.
News For BMY;CELG From The Last 14 Days
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October 16, 2014
06:16 EDTBMYBristol-Myers upgraded to Outperform from Market Perform at BMO Capital
October 15, 2014
09:57 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
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October 14, 2014
11:23 EDTBMYBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
08:05 EDTBMYBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
07:13 EDTBMYBioFlorida to hold a conference
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October 10, 2014
10:03 EDTBMYBristol-Myers receives orphan status for melanoma treatment
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08:41 EDTCELGCelgene reports apremilast significantly improved preexisting psoriasis in study
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08:39 EDTCELGCelgene says data show Apremilast treatment resulted in improved quality of life
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08:19 EDTBMYMedivir announces Janssen initiates enrolment in phase II IMPACT study
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October 8, 2014
08:03 EDTBMYBristol-Myers resolves outstanding U.S. litigation on efavirenz
Bristol-Myers Squibb Company says it has "successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva -- efavirenz -- and Atripla products. Accordingly, we believe that loss of exclusivity in the U.S. for efavirenz should not occur until December 2017. Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative treatments to help patients prevail over serious disease. Atripla is currently the #1 prescribed U.S. regimen in its category, with over 8 million prescriptions written since its launch in 2006. Earlier this year the company submitted a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments including an HIV-1 attachment inhibitor, an HIV-1 maturation inhibitor and an anti-PD-L1. The establishment of intellectual property rights allows Bristol-Myers Squibb to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We will continue to defend our intellectual property rights against infringement as we remain focused on providing a deep and broad portfolio of innovative medicines to patients around the world."
07:18 EDTBMYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
07:11 EDTCELGEuropean Academy of Dermatology and Venereology to hold a conference
23rd EADV Congress is being held in Amsterdam, The Netherlands on October 8-12.
October 7, 2014
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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07:31 EDTCELGCelgene to present long-term efficacy and safety data on oral Otezla
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, announced that the latest research findings on OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4, in plaque psoriasis and psoriatic arthritis will be presented at the 23rd European Academy of Dermatology and Venereology Congress in Amsterdam, October 8 – 12. In total, 11 abstracts will be presented at the meeting. OTEZLA data to be presented include long-term results from Celgene’s pivotal trial, ESTEEM 2 and pooled analyses of safety and tolerability results from the ESTEEM 1 and 2 studies in patients with moderate to severe plaque psoriasis. Additional analyses will evaluate the effect of OTEZLA on pruritus, difficult-to-treat areas such as nail and scalp, and palmoplantar psoriasis, work productivity and improvements in health-related quality of life. An analysis of long-term results from the PALACE clinical trial program evaluating OTEZLA in patients with active psoriatic arthritis will also be presented at the meeting. The analysis assesses the effect of OTEZLA treatment through 52 weeks on the signs and symptoms of psoriatic arthritis, including enthesitis and dactylitis in patients with pre-existing enthesitis or dactylitis.
07:24 EDTCELGAlliance for Regenerative Medicine
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October 6, 2014
08:04 EDTBMYBristol-Myers announces Opdivo clinical trial with Novartis therapies
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08:02 EDTBMYBristol-Myers announces research collaboration to evaluate Opdivo
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07:34 EDTCELGAlliqua expands exclusive licensing agreement with Celgene
Alliqua Biomedical (ALQA) announced that the company has amended its exclusive licensing agreement with Celgene Cellular Therapeutics, or CCT, a subsidiary of Celgene (CELG). Under the terms of the amended agreement, Alliqua has received the right to market the advanced wound care product, Biovance, for podiatric and orthopedic applications. Biovance is a, decellularized, and dehydrated, human amniotic membrane allograft, which was commercially launched by Alliqua on April 23. The product is currently indicated for the management of non-infected partial- and full-thickness wounds, including chronic and acute wounds such as diabetic ulcers, pressure ulcers, venous ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds, trauma wounds, and draining wounds, The field of use for Biovance has been expanded to include podiatric and orthopedic applications including sports medicine-related conditions pertaining to use during the repair of tendon, nerve and bone in the foot and ankle, as well as other surgical procedures in these specialty areas.
05:14 EDTBMYNovartis announce clinical collaboration with Bristol-Myers
Novartis (NVS) announced that it has entered into a clinical collaboration with Bristol-Myers Squibb (BMY) to evaluate the safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, Opdivo, in Phase I/II trials of patients with non-small cell lung cancer, or NSCLC. Both studies will be conducted by Novartis. One trial will evaluate the combination of Opdivo with Zykadia, an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. A second study will investigate Opdivo with INC280, a potent and highly selective inhibitor of c-MET receptor tyrosine kinase, and separately with EGF816, a potent, third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations. INC280 and EGF816 are currently being investigated in various Phase I/II NSCLC trials. Additional details of the collaboration were not disclosed.
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