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News Breaks
February 5, 2014
06:18 EDTMRK, AMGNAmgen, Merck collaborate on combination treatment for advanced melanoma
Amgen (AMGN) and Merck (MRK), known as MSD outside the United States and Canada, announced that they have entered into an agreement through a subsidiary to evaluate the safety and efficacy of talimogene laherparepvec, an investigational oncolytic immunotherapy, combined with MK-3475, an investigational anti-PD-1 immunotherapy, in a Phase 1b/2 study of patients with mid- to late-stage melanoma. The multicenter, open-label clinical trial will be conducted in two parts and is planned to begin in the fall of 2014. Phase 1b is designed to determine the safety and tolerability of talimogene laherparepvec in combination with MK-3475 in patients with previously untreated, unresected, stage IIIB to IVM1a melanoma. The Phase 2 portion will evaluate efficacy, as assessed by the confirmed objective response rate, with talimogene laherparepvec in combination with MK-3475 versus MK-3475 alone in patients with previously untreated, unresected, stage IIIB to IVM1c melanoma. The study will also evaluate the efficacy of treatment with talimogene laherparepvec in combination with MK-3475 following disease progression on MK-3475 alone.
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November 24, 2014
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.
07:31 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
08:02 EDTAMGNAmgen 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 EDTMRKInforma Business Information to hold a conference
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07:09 EDTAMGNJefferies to hold a conference
2014 Global London Healthcare Conference is being held in London, England on November 19-20.
November 18, 2014
16:02 EDTAMGNAmgen presents long-term data on safety, efficacy of evolocumab
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09:23 EDTAMGNAmgen to host conference call
Management discusses Amgen's cardiovascular program, as well as the evolocumab data presented at the American Heart Association (AHA) Scientific Sessions 2014, on a conference call to be held on November 18 at 7 pm. Webcast Link
07:03 EDTAMGNAmgen management to meet with UBS
Meeting to be held in Zurich on November 18 hosted by UBS.
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.
08:34 EDTMRKMerck says IMPROVE-IT met primary endpoint
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November 16, 2014
13:26 EDTMRKMerck: KEYTRUDA showed superiority to chemotherapy for primary endpoint of PFS
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November 14, 2014
16:58 EDTAMGNThird Point gives quarterly update on stakes
NEW STAKES: Alibaba (BABA), eBay (EBAY), Bed Bath & Beyond (BBBY), Shire (SHPG), and Parker Hannifin (PH). INCREASED STAKES: Actavis (ACT), Amgen (AMGN), EQT (EQT), Sensata (ST), Coca-Cola Enterprises (CCE). DECREASED STAKES: Williams Cos (WMB), Ally Financial (ALLY), Cheniere Energy (LNG), YPF (YPF), and FedEx (FDX). LIQUIDATED STAKES: AIG (AIG), T-Mobile (TMUS), Rackspace (RAX), Hertz (HTZ), and Citrix Systems (CTXS).
14:53 EDTMRKCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies 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). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
11:46 EDTMRKMerck management to meet with SunTrust
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09:38 EDTAMGNJANA Partners gives quarterly update on stakes
NEW STAKES: AMD (AMD), AECOM Technology (ACM), Alibaba (BABA), McDonald's (MCD), Amgen (AMGN), Gaming and Leisure Properties (GLPI), Iron Mountain (IRM), iRobot (IRBT), Seadrill Partners (SDLP), Valeant (VRX). INCREASED STAKES: eBay (EBAY), Charter (CHTR), Groupon (GRPN), HD Supply (HDS), Hertz (HTZ). DECREASED STAKES: Apache (APA). LIQUIDATED STAKES: CBS (CBS), Endo (ENDP), FMC Corporation (FMC), SeaWorld (SEAS), SunEdison (SUNE).
09:37 EDTAMGNJANA reports new stakes in McDonald's, AECOM, Amgen
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07:14 EDTAMGNAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
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