News Breaks |
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| March 10, 2013 |
| 14:31 EDT |  | PFE | Pfizer: New trial results support treatment with Inspra
Pfizer announced results from the REMINDER trial showing statistically significant risk reductions in the primary composite efficacy endpoint. The results were presented for the first time during the Late Breaker Clinical Trial session at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco today. The REMINDER trial demonstrated a statistically significant 42.9% relative risk reduction in the primary endpoint with p < 0.0001 (95% confidence interval [CI] 0.439, 0.742) in patients with acute STEMI when eplerenone was initiated within the first 24 hours of onset of symptoms. Overall, the adverse events reported in the REMINDER trial were consistent with those already known for eplerenone, primarily hyperkalemia. Eplerenone is not approved for use in the patient population studied in the REMINDER trial in any market. The improvement in outcome was mainly driven by a significant reduction of the BNP / NT-proBNP biomarker component at 1 month. BNP/NT-proBNP has been shown to be an important marker for short- and long-term prognosis in patients with myocardial infarction in the presence or absence of preserved ejection fraction. An elevation of BNP / NT-proBNP after 1 month was observed less frequently in the eplerenone group 81(16.0%) than in the placebo group 131(25.9%) (adjusted HR, 0.584; 95% CI 0.441-0.773; p=0.0002). Over the course of the study, the incidence of hyperkalemia (elevated potassium defined as serum potassium levels exceeding 5.5 mEq/L) occurred in 5.6% vs. 3.2% (p=0.09) in the eplerenone and placebo groups, respectively. Hypokalemia (serum potassium level below 3.5 mEq/L) occurred more frequently in the placebo group with 1.4% vs. 5.5% |
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News For PFE From The Last 14 Days Check below for free stories on PFE the last two weeks. |
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| May 22, 2013 |
| 08:59 EDT | | PFE | On The Fly: Pre-market Movers
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| 08:06 EDT | | PFE | Zoetis comments on Pfizer’s split-off plans for remaining interest
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| 08:04 EDT | | PFE | Pfizer announces plan to split-off remainder of Zoetis
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| 08:02 EDT | | PFE | Pfizer announces plan to split-off remainder of Zoetis
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| May 21, 2013 |
| 07:16 EDT |  | PFE | Pfizer management to meet with Leerink
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| May 20, 2013 |
| 17:04 EDT | | PFE | Pfizer discontinues phase 3 study of inotuzumab ozogamicin
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| May 16, 2013 |
| 08:55 EDT | | PFE | BofA/Merrill's pharmaceuticals analysts hold analyst/industry conference call
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| May 10, 2013 |
| 16:29 EDT |  | PFE | On The Fly: Closing Wrap
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| 12:31 EDT | | PFE | On The Fly: Midday Wrap
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| 11:48 EDT |  | PFE | Drugmakers to face pressure on U.S. prices, Reuters says
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| 09:21 EDT | | PFE | On The Fly: Pre-market Movers
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| 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 |
| 10:17 EDT | | PFE | Shire trades higher in London amid takeover chatter, Guardian says
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