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News Breaks
February 27, 2014
06:11 EDTMRK, BMY, NVOFDA eases worries regarding certain diabetes medications, AP says
The federal Food and Drug Administration and its European counterpart started reviews last year of diabetes drugs which include Merck's (MRK) Januvia and Janumet, Novo Nordisk's (NVO) Victoza and Bristol-Myers Squibb's (BMY) Byetta and Bydureon, reported the Associated Press. Both U.S. and European regulators have found no evidence of a link between these drugs and pancreas problems or pancreatic cancer. Reference Link
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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 EDTBMYLeerink 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-nave 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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November 14, 2014
14:53 EDTBMY, MRKCVS 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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07:14 EDTBMYAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
06:05 EDTBMYBristol-Myers to construct biologics manufacturing facility in Ireland
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November 13, 2014
13:32 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.
10:01 EDTBMYOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: ATK (ATK) downgraded to Hold from Buy at Argus... Adeptus Health (ADPT) downgraded to Hold from Buy at Deutsche Bank... American Woodmark (AMWD) downgraded to Neutral from Buy at Longbow... Avnet (AVT) downgraded to Sell from Neutral at Goldman... Baxano Surgical (BAXS) downgraded to Sell from Buy at Summer Street... Beazer Homes (BZH) downgraded to Neutral from Overweight at JPMorgan... Bristol-Myers (BMY) downgraded to Equal Weight from Overweight at Morgan Stanley... Centene (CNC) downgraded to Market Perform from Outperform at FBR Capital... Cherry Hill Mortgage (CHMI) downgraded to Equal Weight from Overweight at Barclays... Discover (DFS) downgraded to Hold from Buy at Deutsche Bank... Fleetmatics (FLTX) downgraded to Neutral from Buy at BofA/Merrill... Gazprom (OGZPY) downgraded to Neutral from Overweight at JPMorgan... Jabil Circuit (JBL) downgraded to Neutral from Buy at Goldman... LabCorp (LH) downgraded to Hold from Buy at Deutsche Bank... Laredo Petroleum (LPI) downgraded at BMO Capital... Macy's (M) downgraded to Market Perform from Outperform at Wells Fargo... Madison Square Garden (MSG) downgraded to Equal Weight from Overweight at Morgan Stanley... Marvell (MRVL) downgraded to Sell from Neutral at Goldman... Meritor (MTOR) downgraded to Neutral from Overweight at Piper Jaffray... Swedbank (SWDBY) downgraded to Underperform from Sector Perform at RBC Capital... TransGlobe (TGA) downgraded to Sector Perform from Outperform at Scotia Capital... UIL Holdings (UIL) downgraded to Hold from Buy at Argus... Verint Systems (VRNT) downgraded to Fair Value from Buy at CRT Capital... ZAIS Financial (ZFC) downgraded to Equal Weight from Overweight at Barclays.
06:09 EDTBMYBristol-Myers' oral daclatasvir regimen shows high cure rates for hepatitis C
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06:05 EDTBMYBristol-Myers' daclatasvir reports high cure rates for genotype 3 hepatitis C
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04:23 EDTBMYBristol-Myers downgraded to Equal Weight from Overweight at Morgan Stanley
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November 12, 2014
11:17 EDTMRK, BMYLeerink major pharma & biotech analysts hold analyst/industry conference call
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08:13 EDTMRKBoston Biotech to hold a conference
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