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News For PFE;ENDP From The Last 14 Days Check below for free stories on PFE;ENDP the last two weeks. |
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| May 10, 2013 |
| 08:08 EDT |  | PFE | Pain Therapeutics discloses Pfizer reassessing continued Remoxy partnership
Pain Therapeutics (PTIE) disclosed a letter its CEO was sent from partner Pfizer (PFE) in which the drug maker said it is reassessing its endorsement of the Remoxy program "given the years of delay, additional cost incurred to bring the program to this point and development work left in the program." Pfizer said it will be reaching out to Pain Therapeutics "shortly" to have a confidential discussion about the terms of the companies' contractual agreement over the pain drug. Pfizer that it appears there is a regulatory pathway forward for Remoxy, but that the company does not expect to respond to submit a Complete Response letter for Remoxy to the FDA before mid-2015. Pfizer added in its letter to Pain Therapeutics "no final decision has been made at this time" on how it will proceed with the Remoxy development program. Shares of Pain Therapeutics fell 47% to $2.81 in pre-market trading following the disclosure of the correspondence. |
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| 07:46 EDT | | PFE | DURECT says additional clinical studies needed for Remoxy
DURECT (DRRX) announced that Pfizer (PFE) has provided an update on Remoxy in a regulatory filing. Pfizer's disclosure included: "We have been working to address the issues raised in the letter, which primarily relate to manufacturing. We met with the FDA in March 2013 to discuss our plan to address the June 2011 "complete response" letter. We received written guidance from the FDA in May regarding required next steps, including additional clinical studies, to address the letter. Based on this guidance, we are considering our options with respect to Remoxy. If we elect to continue development of Remoxy, we would not expect to submit a response to the 'complete response' letter before mid-2015." DURECT said it understands from Pfizer that additional clinical studies are necessary and include, in part, a pivotal bioequivalence study with the modified formulation to bridge to the clinical data conducted with the original formulation, as well as an abuse potential study with the modified Remoxy formulation. Remoxy is based on DURECT's ORADUR technology. Shares of Pfizer's Remoxy partner Pain Therapeutics (PTIE) are down 56% in pre-market trading, while shares of DURECT are down 13%, or 20c, to $1.39. |
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| May 9, 2013 |
| 16:52 EDT | | ENDP | BDSI's Phase 3 trials for BEMA Buprenorphine to finish late 2013 or early 2014
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| 16:44 EDT | | ENDP | Blue Ridge Capital reports 5.98% passive stake in Endo Health
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| 10:17 EDT |  | PFE | Shire trades higher in London amid takeover chatter, Guardian says
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| May 8, 2013 |
| 10:33 EDT | | PFE | Bristol-Myers, Pfizer announced results from ARISTOTLE trial subanalysis
Bristol-Myers (BMY) and Pfizer (PFE) announced yesterday that results from a prespecified subanalysis of the ARISTOTLE trial were published in Circulation, the peer-reviewed journal of the American Heart Association. Results from the subanalysis showed that the reductions in stroke or systemic embolism, number of major bleeding events and mortality demonstrated with Eliquis compared to warfarin in the ARISTOTLE trial were consistent across subgroups defined based on levels of International Normalized Ratio control in patients with nonvalvular atrial fibrillation. This story corrects a headline from yesterday. |
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| 10:00 EDT |  | ENDP | On The Fly: Analyst Downgrade Summary
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| 08:40 EDT | | ENDP | Endo Health downgraded to Neutral from Buy at Buckingham
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| 07:01 EDT | | ENDP | Endo Health downgraded to Underperform from Neutral at Cowen
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| May 7, 2013 |
| 12:32 EDT |  | PFE | High option volume stocks: ALDW BC NMM PFE AEP
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| 08:09 EDT | | PFE | Accelrys, Pfizer extend agremeent for global deployment of Lifecycle software
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| 07:08 EDT |  | ENDP | Endo Health sees FY13 adjusted EPS $4.40-$4.70, consensus $4.50
Sees FY13 revenue $2.8B-$2.95B, consensus $2.9B. Sees FY13 effective tax rate 28.5%-29.5% |
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| 07:07 EDT | | ENDP | Endo Health reports Q1 adjusted EPS $1.09, consensus $1.09
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| May 6, 2013 |
| 17:03 EDT | | PFE | Bristol-Myers, Pfizer announce publication of ARISTOTLE trial
Bristol-Myers Squibb (BMY) and Pfizer (PFE) announced that results from a prespecified subanalysis of the ARISTOTLE trial were published in Circulation, the peer-reviewed journal of the American Heart Association. Results from this subanalysis showed that the reductions in stroke or systemic embolism, number of major bleeding events and mortality demonstrated with Eliquis compared to warfarin in the ARISTOTLE trial were consistent across subgroups defined based on levels of International Normalized Ratio control in patients with nonvalvular atrial fibrillation. Based on the results of the subanalysis, the benefits of Eliquis compared with warfarin for stroke or systemic embolism, bleeding, and mortality appear similar across the range of centers' and patients' quality of INR control. |
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| 16:23 EDT | | ENDP | GreenLight XPS laser therapy safe and effective with faster recovery for BPH
Data to be presented at the American Urological Association Annual Meeting demonstrate that treatment for Benign Prostatic Hyperplasia, or BPH, with GreenLight XPS laser therapy with MoXy fiber, instead of transurethral resection of the prostate, or TURP, results in significantly shorter hospitalization, catheterization, and recovery times for patients, while maintaining equivalent safety and efficacy. The findings from the prospective, multicenter, randomized GOLIATH trial, demonstrate the equivalence in safety and effectiveness of the 180W GreenLight XPS system for addressing lower urinary tract symptoms associated with BPH. Manufactured by American Medical Systems, an Endo Health Solutions subsidiary, GreenLight XPS is the most widely used BPH laser treatment currently on the market. |
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| 08:02 EDT | | PFE | Pfizer launches Viagra home delivery, powered by CVS/pharmacy
To meet the needs of consumers who are increasingly going online to purchase prescription medications, Pfizer (PFE) launched Viagra home delivery, a new prescription-fulfillment website for Viagra tablets, Pfizer’s most counterfeited medicine. The site, which is powered by CVS/pharmacy (CVS) and accessible through Viagra.com, offers men with erectile dysfunction an opportunity to purchase Viagra online with a valid prescription from a trusted source. |
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| 07:51 EDT | | PFE | Pfizer to sell Viagra directly to patients on its website, Fox News reports
In a move that changes the drug industry's distribution model, Pfizer told The Associated Press that it will begin selling Viagra directly to patients on its website, reports Fox News. Men still will need a prescription to buy it, and Pfizer is offering three free pills with the first order and 30% off the second one. Reference Link |
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| 07:34 EDT |  | PFE | Conference Forum to host a summit
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| 07:24 EDT | | PFE, ENDP | Drug companies attempt to make painkillers that can't be abused, WSJ reports
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| 07:18 EDT | | PFE | American Congress of Obstetrics and Gynecology to hold annual meeting
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