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July 17, 2014
08:08 EDTPFE, BMYBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced that the first patient has been enrolled into a Phase IV clinical trial called EMANATE assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation undergoing cardioversion. Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with NVAF. Cardioversion is a commonly used, effective method of converting atrial fibrillation to a normal rhythm, allowing the heart to pump more effectively. Traditionally, anticoagulation is administered for a minimum of three weeks prior to cardioversion and for four weeks afterward. In some patients, early cardioversion can be performed on the same day or within days of new-onset NVAF, usually after imaging, to confirm the absence of a pre-existing thrombus in the heart, which could be dislodged during the cardioversion procedure and cause a stroke. EMANATE, a randomized, open-label clinical trial, will assess the effectiveness and safety of Eliquis compared with usual care initiated in patients with NVAF expected to undergo cardioversion after short-term anticoagulation, in a clinical practice setting. In NVAF patients presenting at least 48 hours after the onset of NVAF, early cardioversion will be performed after excluding a thrombus by imaging, on the same day or within a few days. In NVAF patients presenting within 48 hours of the onset of NVAF, cardioversion will be performed promptly without prior imaging. In all patients, Eliquis or usual care will be initiated prior to cardioversion and continued for up to 30 days post-cardioversion. The EMANATE trial is anticipated to enroll 1,500 eligible patients from the U.S., Canada, Europe and Asia. Patients will be randomized 1:1 to Eliquis or usual care, to be administered for up to 30 days following early cardioversion or 90 days post randomization if cardioversion is not performed within this timeframe. The primary efficacy endpoints are the occurrence of acute stroke, systemic embolism and all-cause death. Primary safety endpoints are major bleeding and clinically relevant non-major bleeding.
News For BMY;PFE From The Last 14 Days
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August 27, 2015
10:35 EDTBMYBristol-Myers calls active
Bristol-Myers August weekly 61 and 61.5 calls are active on total call volume of 7K contracts (4K puts). August weekly call option implied volatility is at 35, September is at 34, October is at 28; compared to its 52-week range of 14 to 36. Active call volume suggests traders taking positions for price movement.
07:51 EDTBMYRoche catching up fast to Bristol-Myers in immuno-oncology, says Jefferies
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07:24 EDTPFEPfizer shares even more compelling after recent weakness, says Piper Jaffray
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06:55 EDTPFEHospira sees merger closing on or about September 3
Hospira (HSP) said in a regulatory filing that on August 21, Hospira and Pfizer (PFE) received clearance from the U.S. FTC, relating to the pending merger of Hospira with Perkins Holding Company, a wholly-owned subsidiary of Pfizer. All required regulatory approvals have now been secured, though the merger remains conditioned upon the expiration of a post-clearance waiting period in one foreign jurisdiction. Hospira expects the merger to close on or about September 3.
05:28 EDTBMYAllied-Bristol Life Sciences announces licensing agreement with Yale University
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August 26, 2015
07:32 EDTPFEPfizer launches Phase 3 trial of targeted therapy for breast cancer patients
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06:16 EDTPFEAlvogen to acquire product portfolio from Pfizer for US market
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August 25, 2015
14:16 EDTPFEMylan launches generic version of Pfizer's Zosyn Injection
Mylan (MYL) announced the U.S. launch of Piperacillin and Tazobactam for Injection USP, 3.375g Single-dose Vials, which is the generic version of Pfizer's (PFE) Zosyn Injection. This product is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of certain bacteria. Piperacillin and Tazobactam for Injection USP, 3.375g Single-dose Vials had U.S. sales of approximately $72.1M for the 12 months ending June 30, 2015, according to IMS Health. Mylan's launch of this product adds to the company's growing portfolio of more than 145 injectable products available to patients in the U.S. across a broad array of therapeutic categories including oncology, anti-infectives, anesthesia/pain management and cardiovascular.
August 24, 2015
12:57 EDTPFEFTC requires Pfizer to sell rights to four products as condition of buying Hospira
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09:45 EDTBMYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Bank of America (BAC) upgraded to Outperform from Market Perform at Keefe Bruyette... Bristol-Myers (BMY) upgraded to Neutral from Underweight at Piper Jaffray... Chevron (CVX) upgraded to Neutral from Underperform at BofA/Merrill... Abercrombie & Fitch (ANF) upgraded to Overweight from Neutral... Nike (NKE) upgraded to Outperform from Market Perform at Telsey Advisory... DreamWorks (DWA) upgraded to Buy from Neutral at B. Riley... Caesarstone (CSTE) upgraded to Overweight from Equal Weight at Barclays... TransAlta (TAC) upgraded to Outperform from Market Perform at BMO Capital... Sarepta (SRPT) upgraded to Overweight from Neutral at Piper Jaffray... AutoZone (AZO) upgraded to Buy from Neutral at BofA/Merrill... Royal Dutch Shell (RDS.A) upgraded to Buy from Hold at Jefferies... Allscripts (MDRX) upgraded to Buy from Hold at Argus... China Unicom (CHU) upgraded to Buy from Hold at Jefferies... Ross Stores (ROST) upgraded to Buy from Neutral at Buckingham.
08:16 EDTBMY, PFEBristol-Myers, Pfizer to present new data on Eliquis at ESC Congress 2015
Bristol-Myers Squibb Company (BMY) and Pfizer Inc. (PFE) announced that 22 abstracts will be presented at the ESC Congress 2015, to be held August 29 to September 2 in London, United Kingdom. The new data reinforce the Alliance's commitment to the ongoing evaluation of Eliquis in both the nonvalvular atrial fibrillation and venous thromboembolism patient populations. In addition, data from the AEGEAN study evaluating adherence among NVAF patients further extends the Alliance's commitment to patient care.
08:01 EDTPFEPfizer receives clearance from FTC for Hospira acquisition
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07:08 EDTBMYBristol-Myers upgraded to Neutral from Underweight at Piper Jaffray
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August 23, 2015
12:35 EDTPFE, BMYBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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August 21, 2015
08:01 EDTPFEPfizer says two Phase 3 Trumenba studies met primary endpoints
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August 20, 2015
11:24 EDTPFEPfizer says Ibrance application validated by EMA
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06:01 EDTBMYBristol-Myers announces Canadian approval of Daklinza
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August 19, 2015
05:46 EDTBMYStocks with implied volatility movement; ESRX BMY
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August 18, 2015
07:22 EDTBMYBristol-Myers combo data could push shares above $70, says JPMorgan
JPMorgan analyst Chris Schott says the risk/reward for shares of Bristol-Myers Squibb looks "very attractive" ahead of the World Conference on Lung Cancer, which begins September 6. Data at the conference supportive of an Opdivo/Yervoy combo would represent a clear catalyst for the shares, Schott tells investors in a research note. Bristol is "already extremely well-positioned" in the advanced non-small cell lung cancer market, and data suggesting that the company has addressed toxicity concerns with the combo could push the stock above $70, Schott argues. Bristol closed yesterday up 39c to $63.47. The analyst sees limited downside to stock even with disappointing results at the World Conference on Lung Cancer. He reiterates an Overweight rating on Bristol with a $75 price target.
August 17, 2015
08:43 EDTBMYBristol-Myers sells Ixempra to R-PHARM, terms not disclosed
R-PHARM announces the acquisition of Ixempra from Bristol-Myers Squibb. Ixempra received marketing approval from the FDA in 2007 and in 18 other markets globally. Ixempra is indicated as monotherapy or in combination with capecitabine for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine. With the acquisition, R-PHARM has launched its U.S. commercial operations, and it is now responsible for all activities surrounding Ixempra's manufacture, distribution, sales, and reimbursement. Financial terms were not disclosed.
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