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May 27, 2014
07:09 EDTBMY, INCY, MRKIncyte, Bristol-Myers enter agreement to evaluate two Immunotherapies
Bristol-Myers Squibb (BMY) and Incyte (INCY) 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, nivolumab, and Incyte’s oral indoleamine dioxygenase-1 inhibitor, INCB24360, in a Phase I/II study. Multiple tumor types will be explored in the study, which could potentially include melanoma, non-small cell lung, ovarian, colorectal, squamous cell carcinoma of the head and neck and diffuse large B-cell lymphoma. The study, which is expected to begin in Q4 will be co-funded by the companies and conducted by Incyte. Additional details of the collaboration were not disclosed. INCB24360 is currently in Phase I/II development for metastatic melanoma in combination with ipilimumab and as monotherapy for ovarian cancer. Incyte has also established a clinical agreement with Merck (MRK) to combine INCB24360 with Merck’s (MRK) anti-PD-1 immunotherapy checkpoint inhibitor in a non-small cell lung cancer study.
News For INCY;BMY;MRK From The Last 14 Days
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November 26, 2014
11:36 EDTBMYBristol-Myers receives CRL from FDA for daclatasvir
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November 25, 2014
13:00 EDTMRKMerck raises quarterly dividend to 45c from 44c per share
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November 24, 2014
09:00 EDTBMYBristol-Myers, Five Prime announce clinical collaboration for Opdivo, FPA008
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08:02 EDTMRKMerck submits NDA to Japanese PMDA for Omarigliptin
Merck announced that the company has submitted a new drug application for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency. The new drug application for omarigliptin is based on a comprehensive clinical development program in Japan. The results from the first Phase 3 study of omarigliptin, conducted in Japan, were presented recently at the 50th European Association for the Study of Diabetes Annual Meeting. Japan is the first country with a regulatory filing for omarigliptin. Worldwide, Merck is supporting omarigliptin with a clinical development program that includes nine Phase 3 clinical trials involving approximately 7,500 patients with type 2 diabetes in support of planned regulatory filings.
07:33 EDTMRKMerck, NewLink enter licensing, collaboration agreement for Ebola vaccine
Merck (MRK) and NewLink Genetics (NLNK) announced that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink's investigational rVSV-EBOV vaccine candidate. Under the terms of the agreement, Merck will be granted the exclusive rights to the rVSV-EBOV vaccine candidate as well as any follow-on products. The vaccine candidate is under an exclusive licensing arrangement with a wholly-owned subsidiary of NewLink Genetics. Under these license arrangements, the PHAC retains non-commercial rights pertaining to the vaccine candidate. Phase I clinical trials of the rVSV-EBOV vaccine are now underway at the Walter Reed Army Institute of Research and the NIAID at the NIH. Additional Phase I studies are underway or planned to begin in the near future at clinical research centers in Switzerland, Germany, Kenya, and Gabon in a World Health Organization-coordinated effort, and in Canada by the Canadian Immunization Research Network.
07:33 EDTINCYBrean Capital to hold a summit
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07:31 EDTMRKMerck, NewLink Genetics enter into agreement for investigational Ebola vaccine
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November 21, 2014
07:51 EDTMRKBofA/Merrill biotech analysts hold analyst/industry conference call
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November 20, 2014
08:25 EDTINCYIncyte management to meet with UBS
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07:11 EDTMRKBofA/Merrill to hold a conference
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November 19, 2014
07:52 EDTBMY, MRKInforma Business Information to hold a conference
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06:07 EDTBMYBristol-Myers' Opdivo for melanoma shows positive Phase 3 results
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November 18, 2014
06:39 EDTMRKAstraZeneca: 'Hard to comment' on whether Pfizer will come back, Reuters reports
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November 17, 2014
11:55 EDTMRKMerck says IMPROVE-IT study met all primary, secondary endpoints
Merck announced that the investigational IMPROVE-IT study met its primary and all secondary composite efficacy endpoints. In IMPROVE-IT, patients taking the LDL-cholesterol-lowering medicine VYTORIN – which combines simvastatin with the non-statin ZETIA -- experienced significantly fewer major cardiovascular events than patients treated with simvastatin alone. The results from this 18,144-patient study of high-risk patients presenting with acute coronary syndromes were presented today during the late-breaking clinical trials session at the American Heart Association 2014 Scientific Sessions. Merck plans to submit the data from IMPROVE-IT to the U.S. Food and Drug Administration in mid-2015 to support a new indication for reduction of major cardiovascular events for VYTORIN and ZETIA. VYTORIN and ZETIA are currently indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia. The current U.S. Prescribing Information for both products states that the effect of ezetimibe on cardiovascular morbidity and mortality, alone or incremental to statin therapy, has not been determined.
11:06 EDTBMY, INCYLeerink biotech analysts hold an analyst/industry conference call
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08:34 EDTMRKMerck says IMPROVE-IT met primary endpoint
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08:13 EDTBMYPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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08:10 EDTBMYBristol-Myers presents results from Phase IIIb AVERT trial at ACR
Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase IIIb AVERT trial that investigated the use of Orencia plus methotrexate in biologic and MTX-naïve citrullinated protein-positive early moderate to severe rheumatoid arthritis patients. These data were presented this week at the American College of Rheumatology 2014 annual meeting. Orencia is currently indicated in adults for moderate to severe RA. Orencia should not be administered with tumor necrosis factor antagonists and should not be used with other biologic RA drugs. One of the analyses looked at anti-CCP antibodies, which are a marker of RA and may contribute to disease progression. The analysis assessed the development of anti-CCP antibodies in patients with early rapidly progressing RA by measuring isotypes and the number of epitopes recognized after treatment with Orencia plus MTX, Orencia alone, or MTX alone. Results demonstrated Orencia plus MTX numerically reduced the concentrations of all CCP isotypes and the average number of epitopes recognized over one year of treatment more than Orencia alone or MTX alone. Over 12 months of treatment, 6.7 percent, 12.1 percent, and 7.8 percent of patients on Orencia plus MTX, Orencia alone, and MTX alone, respectively, experienced a serious adverse event and 1.7 percent, 4.3 percent and 2.6 percent led to discontinuation. Serious infections were observed in 0.8 percent of patients in the combination arm and 3.4 percent in the Orencia monotherapy arm. None of the patients in the MTX alone arm experienced a serious infection. Malignancies were reported in 0.8 percent, 1.7 percent, and 0 percent of patients in the Orencia + MTX, Orencia, and MTX arms, respectively. Additionally at ACR, investigators presented 12-month efficacy data from AVERT, including new results assessing the effect of Orencia on more clinically stringent remission criteria than DAS-defined remission, as well as new MRI data. Significantly more patients on Orencia plus MTX achieved the stringent clinical endpoint of Boolean-defined remission at 12 months.
November 16, 2014
13:26 EDTMRKMerck: KEYTRUDA showed superiority to chemotherapy for primary endpoint of PFS
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13:07 EDTBMYBristol-Myers announces results from CheckMate -066 study
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