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News Breaks
March 26, 2014
06:27 EDTBMY, INCY, MRK, AZNCitigroup expects Bristol-Myers to report positive Yervoy data
Citigroup expects data for Bristol-Myers' (BMY) Yervoy in high risk stage III melanoma will increase relapse free survival by 30%-40% versus the placebo. Citi thinks peak sales for this indication will be at least $3B per year and thinks positive data from Bristol could "materially diminish" the outlook in metastatic melanoma for Merck (MRK), Incyte (INCY) and AstraZeneca (AZN). The firm keeps a Buy rating on Bristol-Myers with a $60 price target saying it does not expect Yervoy to face significant competition until 2019.
News For BMY;MRK;INCY;AZN From The Last 14 Days
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August 21, 2014
09:54 EDTAZNPotential Pfizer, AstraZeneca deal seen around year-end, Reuters says
Investors and analysts see Pfizer (PFE) making another attempt to acquire AstraZeneca (AZN) around year-end, even though talks between the two can resume on August 26 per British takeover rules, Reuters reports. Reference Link
07:47 EDTAZNPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
05:42 EDTAZNIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
August 20, 2014
08:03 EDTBMYBristol-Myers Pfizer to present new Eliquis data
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08:02 EDTBMYBristol-Myers, Celgene enter collaboration agreement for OPDIVO, ABRAXANE
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August 19, 2014
07:01 EDTAZNDOJ closes investigation into PLATO Brilinta clinical trial, plans no action
AstraZeneca today announced that it has received confirmation from the United States Department of Justice that it is closing its investigation into PLATO, a clinical trial with BRILINTA tablets. The government is not planning any further action. Pascal Soriot, CEO, said: “We welcome the Department of Justice’s decision not to pursue further action. We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit BRILINTA offers to patients around the world suffering from acute coronary syndrome. As one of AstraZeneca’s growth platforms, we remain committed to delivering the full potential of this important medicine.” As part of our continued commitment to advancing the science behind cardiovascular medicine, AstraZeneca has initiated a clinical trial program for BRILINTA, its largest program involving more than 80,000 patients worldwide.
August 18, 2014
07:57 EDTBMY, MRK, AZNCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 14, 2014
12:01 EDTAZNThird Point gives quarterly update on stakes
NEW STAKES: Rackspace (RAX), Finisar (FNSR), Amgen (AMGN), Ally Financial (ALLY), and AstraZeneca (AZN). INCREASED STAKES: Dollar General (DG) and Dow Chemical (DOW). DECREASED STAKES: FedEx (FDX), Hertz (HTZ), T-Mobile (TMUS) and Intrexon (XON). LIQUIDATED STAKES: Google Class A (GOOGL), Verizon (VZ) and Mondelez (MDLZ).
August 13, 2014
18:02 EDTMRKMerck provides statement on role of PNEUMOVAX 23 in updated ACIP recommendations
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16:52 EDTMRKMerck confirms FDA approval of BELSOMRA
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15:30 EDTMRKFDA approves Belsomra sleep drug
The Food and Drug Administration approved Belsomra tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance because it can be abused or lead to dependence. Belsomra is made by Merck, Sharpe & Dohme.
08:31 EDTAZNAstraZeneca says Phase 3 trials of lesinurad for gout met primary endpoints
AstraZeneca announced top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor, as a combination therapy for the treatment of patients with symptomatic gout. Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby lowering serum uric acid. In the CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination with allopurinol met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0mg/dL at month 6 compared to allopurinol alone. In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone. Although lesinurad 200mg did not achieve statistical significance at month 6, this dose in combination with febuxostat, was superior to placebo plus febuxostat at all other time points. Results from these Phase III clinical trials will be submitted to a scientific meeting later in 2014. The company is proceeding with preparation of regulatory submissions for lesinurad 200mg combination therapy.
August 12, 2014
05:58 EDTAZNStocks with implied volatility movement; P AZN
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August 8, 2014
10:03 EDTBMYBristol-Myers Hodgkin lymphoma treatment granted orphan drug status
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August 7, 2014
11:02 EDTBMYBristol-Myers enters development pact with Leica Biosystem
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06:13 EDTAZNDynavax says AZD1419 Phase 1 study met secondary endpoints
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