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April 15, 2014
11:25 EDTBMY, BMY, GSK, GSK, MRK, MRK, RHHBY, RHHBYLeerink's pharma and biotech analysts hold an analyst/industry conference call
Pharmaceuticals Analyst Fernandez and Biotech Analyst Liang, along with Key Opinion Leader Dr. Michael B. Atkins, discuss new developments in Renal Cell Carcinoma (RCC) on an Analyst/Industry conference call. Relevant companies BMY, GSK, MRK and RHHBY may be discussed on the Analyst/Industry conference call to be held on April 15 at 12 pm.
News For BMY;GSK;MRK;RHHBY From The Last 14 Days
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November 17, 2015
07:34 EDTRHHBYOphthotech to hold a conference call
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06:08 EDTRHHBYRoche subsidiary to participate in Ophthotech and Novartis agreement
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November 16, 2015
17:05 EDTBMYBristol-Myers announces FDA accepts for priority review sBLA for Opdivo
Bristol-Myers Squibb Company announced that the U.S. FDA has accepted for filing and priority review a supplemental Biologics License Application for Opdivo for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior therapy. The projected FDA action date is March 16, 2016.
08:35 EDTMRKMerck to present Phase 2 hep C therapy data at The Liver Meeting
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07:24 EDTMRKSalomon to hold a conference
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07:00 EDTBMYBristol-Myers announces data from Phase 3 ALLY-3+ trial for Daklinza
Bristol-Myers announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response rates, or cure, have proved harder to achieve. The results show that 100% of patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively.
November 15, 2015
15:19 EDTMRKMerck reports integrated analysis of six trials of elbasvir/grazoprevir
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15:15 EDTMRKMerck reports Phase 3 data on elbasvir/grazoprevir in patients injecting drugs
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November 13, 2015
10:18 EDTRHHBYRoche receives FDA approval for cobas EGFR mutation test
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09:34 EDTRHHBYFDA approves Roche's cobas EGFR Mutation Test
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08:02 EDTMRKMerck: DMC recommends anacetrapib study continue with no changes
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November 12, 2015
17:02 EDTMRKMerck Animal Health to Acquire Harrisvaccines
Merck Animal Health and Harrisvaccines announced the companies have entered into an agreement under which Merck Animal Health will acquire Harrisvaccines, a privately-held company that develops, manufactures and sells vaccines for food production and companion animals. The terms of the agreement were not disclosed. The companies expect the transaction to close in the fourth quarter of 2015.
11:50 EDTRHHBYRoche to restructure manufacturing network for small molecules
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11:50 EDTMRKMerck issues statement regarding CUBICIN patent litigation
Merck issued the following statement regarding the decision of the U.S. Court of Appeals for the Federal Circuit: "The decision validated the patent for CUBICIN that expires on June 15, 2016, but invalidated four patents with expiration dates in 2019 and 2020. The company is reviewing the decision and is considering its next steps, which may include seeking further review at the Federal Circuit or Supreme Court."
November 11, 2015
05:40 EDTBMYFive Prime receives HSR clearance for collaboration agreement with Bristol-Myers
Five Prime (FPRX) announced that the FTC has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Acts of 1976 in connection with the exclusive worldwide license and collaboration agreement with Bristol-Myers (BMY) for the development and commercialization of Five Prime's colony stimulating factor 1 receptor antibody program, including FPA008. With the early termination of the applicable waiting period under the HSR Act, the collaboration agreement with BMS is effective as of November 10, 2015, and the related $350M upfront payment by BMS to Five Prime is due within 30 days of the effective date.
November 10, 2015
18:28 EDTGSKGlaxoSmithKline reports Phase 3 data on belimumab for lupus
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13:40 EDTRHHBYExelixis, Roche announce FDA approval of Cotellic
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13:05 EDTRHHBYGenentech: FDA approves Cotellic in combination with Zelboraf for melanoma
Genentech, a member of the Roche Group, announced that the U.S. FDA approved Cotellic for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf. Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene. Cotellic is Genentech's seventh new medicine approved by the FDA in the past five years. Today's FDA approval is based on results from the Phase III coBRIM study, which showed Cotellic plus Zelboraf reduced the risk of disease worsening or death by about half in people who received the combination, with a median PFS of 12.3 months for Cotellic plus Zelboraf compared to 7.2 months with Zelboraf alone. An interim analysis also showed the combination of Cotellic and Zelboraf helped people live significantly longer than Zelboraf alone. The objective response rate was higher with Cotellic plus Zelboraf compared to Zelboraf alone, as was the complete response rate. Possible serious side effects with Cotellic include risk of skin cancers, increased risk of bleeding, heart problems that can lead to inadequate pumping of the blood by the heart, rash, eye problems, abnormal liver test or liver injury, increased levels of an enzyme in the blood, and photosensitivity. The most common side effects of Cotellic include diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting. Cotellic can also cause changes in blood test results. In September, the Committee for Medicinal Products for Human Use at the European Medicines Agency issued a positive opinion for Roche's marketing authorization application for Cotellic in the European Union. A decision from the European Commission is expected before the end of 2015. Cotellic was approved in Switzerland by Swissmedic in August 2015.
11:09 EDTRHHBYExelixis trading halted, news pending
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11:00 EDTRHHBYFDA announces approval of Cotellic for advanced melanoma
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