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News Breaks
March 19, 2014
08:38 EDTPFE, BMY, PTLAPortola Pharmaceuticals initiates Phase 3 study of andexanet alfa
Portola Pharmaceuticals announced that it has initiated a Phase 3 study of andexanet alfa, the company's investigational Factor Xa inhibitor reversal agent. The study will evaluate the safety and efficacy of andexanet alfa with Bristol-Myers Squibb Company (BMY) and Pfizer Inc.'s (PFE) Factor Xa inhibitor Eliquis. Portola is developing andexanet alfa, an FDA-designated breakthrough therapy, as a potential first-in-class antidote to reverse the anticoagulation activity of Factor Xa inhibitor-treated patients who are suffering a major bleeding episode or who require emergency surgery. The Company is pursuing an Accelerated Approval pathway for andexanet alfa, which is the only agent that has demonstrated reversal of the anticoagulation activity of Factor Xa inhibitors as measured by biomarkers, including anti-Factor Xa activity, in human studies.
News For PTLA;BMY;PFE From The Last 14 Days
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April 21, 2015
08:18 EDTPFEPain Therapeutics resumes responsibility for Remoxy
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08:06 EDTPFEPfizer says Phase 3 inotuzumab ozogamicin study met first primary endpoint
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06:44 EDTBMYBristol-Myers upgraded on early Opdivo success at Morgan Stanley
As previously reported, Morgan Stanley upgraded Bristol-Myers to Overweight from Equal Weight. The firm raised estimates above consensus and increased its price target on the stock to $80 from $60 following confirmation of Opdivo's survival benefits in lung cancer. Morgan Stanley expects Opdivo to be one of the top three pharma-bio launches over the next several years and notes Bristol is ahead of the competition in immuno-oncology combination drug development.
06:15 EDTBMYBristol-Myers upgraded to Overweight from Equal Weight at Morgan Stanley
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April 20, 2015
08:12 EDTBMYVanda names Tom Gibbs as SVP and Chief Commercial OfficerBristol-Myers
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08:02 EDTPFEMerck KGaA, Pfizer initiate Phase III study with Avelumab
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07:20 EDTBMYAmerican Association for Cancer Research to hold annual meeting
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06:05 EDTPFEProvectus receives notice of allowance for PV-10 combined with other drugs
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April 17, 2015
09:41 EDTBMYBristol-Myers up after Phase III Opdivo study met endpoint, trial stopped early
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09:36 EDTBMYActive equity options trading on open
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09:08 EDTBMYBristol-Myers data should be positive, says SunTrust
SunTrust expects the AACR data for Bristol-Myers' CheckMate-069 Opdivo + Yervoy combo, a treatment for melanoma, to show a positive overall response rate and progressive free survival that exceeds its prior -0004 results. The firm notes that the data is due to be presented on April 20. It raised its 2020 Opdivo revenue estimate to $7.1B versus the Street's $6.9B and raised its price target o n he stock to $74 from $70 while keeping a Buy rating on the shares.
08:58 EDTBMYBristol-Myers jumps 4% after Opdivo study stopped early after meeting endpoint
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08:56 EDTBMYBristol-Myers says Phase III Opdivo study met endpoint, trial stopped early
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April 16, 2015
12:16 EDTBMYEli Lilly and Bristol-Myers restructure Erbitux collaboration in N. America
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08:59 EDTBMYGene therapy companies could benefit from increased attention, says Roth Capital
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April 15, 2015
09:08 EDTBMYOn The Fly: Pre-market Movers
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08:04 EDTPFEPfizer: PALOMA-3 trial for IBRANCE met primary endpoint, trial stopped early
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07:41 EDTBMYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
07:03 EDTBMYLexicon and Bristol-Myers select development candidate for neuropathic pain
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April 13, 2015
15:12 EDTPFEMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.
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