New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
April 11, 2014
08:25 EDTPFE, PFE, ACUR, ACURAcura Pharma to host conference call
Management discusses letter agreement with Pfizer providing for termination of Pfizer's license to Acura's AVERSION Technology and the return to Acura of the FDA-approved Oxecta product on a conference call to be held on April 11 at 8:30 am.
News For PFE;ACUR From The Last 14 Days
Check below for free stories on PFE;ACUR the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
August 27, 2014
06:42 EDTPFEPfizer initiated with a Buy at Deutsche Bank
Subscribe for More Information
06:18 EDTACURAcura Pharma awarded NIH grant to fund drug abuse deterrent technology
Acura Pharmaceuticals has been awarded a $300K grant by the National Institute On Drug Abuse of the National Institutes of Health to fund Phase I development of Acura's new, early stage Limitx abuse deterrent technology. The Grant is based on a proposal submitted by the company to advance the development of a self-regulating hydromorphone tablet intended to deter abuse by excess oral consumption of the tablets. The company must complete Phase I development by February 28, 2015. Phase I of the project is intended to optimize the formulation in preparation for clinical testing in Phase II. NIDA funding of Phase II development, for which an application has already been submitted, will be contingent upon Phase I progress, approval of other documents and availability of funds.
August 26, 2014
08:01 EDTPFEPfizer, Merck to collaborate on study evaluating anti-cancer combination regimen
Subscribe for More Information
August 25, 2014
06:29 EDTPFEPfizer mulls possible AstraZeneca offer options, FT says
Subscribe for More Information
August 22, 2014
14:19 EDTPFEViiV Healthcare receives FDA approval for HIV-1 treatment Triumeq
Subscribe for More Information
August 21, 2014
13:32 EDTPFEBristol-Myers, Pfizer announce approval of Eliquis for treatment of DVT, PE
Subscribe for More Information
09:54 EDTPFEPotential 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
08:02 EDTPFEPfizer initiates U.S. EAP for palbociclib.
Pfizer announced that the company has initiated a multi-center, open-label expanded access program in the U.S. for palbociclib. Through the program, palbociclib is being made available for use in combination with letrozole for post-menopausal women with hormone receptor positive human epidermal growth factor receptor 2 negative advanced breast cancer for whom letrozole is considered appropriate therapy.
07:55 EDTPFEActavis volatility expected to move on Pfizer considering new target report
Actavis (ACT) volatility is expected to move on Pfizer (PFE) considering other overseas alternatives, Bloomberg reports. Overall option implied volatility of 27 is near its 26-week average of 31 according to Track Data, suggesting decreasing price movement.
07:47 EDTPFEPfizer 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
August 20, 2014
08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
Subscribe for More Information
August 18, 2014
11:41 EDTPFECubist rises after report sparks takeover interest speculation
Subscribe for More Information
08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
07:57 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 15, 2014
06:17 EDTACURAcura announces preliminary discussions held with FDA for acetaminophen tablet
Acura Pharmaceuticals announced preliminary discussions from a meeting held with the FDA regarding the development pathway for Acura's AVERSION hydrocodone with acetaminophen tablet development candidate, which is intended to provide abuse-deterrent features to address abuse by nasal snorting and injection. In a May 2014 letter to Acura, FDA questioned the relevance of abuse of hydrocodone with acetaminophen products by nasal snorting after reviewing clinical and epidemiology data submitted by Acura. The FDA continues to question the relevance of abuse of hydrocodone with acetaminophen products by the intranasal route of administration and suggested additional information may help better inform their decision. The FDA indicated in the discussions that Acura may conduct an additional nasal abuse liability study for its AVERSION hydrocodone with acetaminophen product candidate, the outcomes of which may help inform the relevance decision as well as establish a reduction in drug liking, which was not statistically significant in an earlier Acura study. The FDA requested further time to deliberate on the issues discussed during the meeting before issuing final meeting minutes. Acura intends to review its clinical data from Study AP-ADF-301 to determine whether to proceed with an additional clinical study for its AVERSION hydrocodone with acetaminophen product candidate and to further evaluate options to address the issues of intranasal abuse and drug liking raised by the FDA.
August 14, 2014
17:05 EDTPFEPfizer says FDA accepted for review BLA for bivalent recombinant LP2086
Pfizer announced that the FDA has accepted for review the Biologics License Application,BLA, for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act, PDUFA, action date of February 14, 2015. “Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “Both the acceptance of Pfizer’s Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents.”

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use