New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 7, 2013
10:16 EDTPFE, JNJ, ELN, LLYFDA offers new guidance on developing drugs for Alzheimer’s disease
The U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer’s disease, before the onset of noticeable dementia. The draft guidance titled, “Guidance for Industry, Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease,” explains the FDA’s current thinking about the way researchers can identify and select patients with early Alzheimer’s disease, or those who are at risk of developing the disease, for participation in clinical trials. For drugs designed to treat patients with overt dementia, the FDA currently requires that treatments not only show an effect on abnormal thinking, but also how well patients function. The goal for these trials is to ensure that any beneficial effect on thinking is associated with a clinically meaningful outcome for the patient, e.g., improvement or lack of decline in how patients feel or function. However, because patients with early Alzheimer’s disease have little-to-no impairment of global functioning, it is difficult to assess changes in function in these patients. This can make it difficult to determine if a given treatment’s effect is clinically important. FDA said it is seeking public comment on the draft guidance for 60 days. Bapineuzumab, an experimental treatment for Alzheimer’s disease, is being developed jointly by Pfizer (PFE) and Johnson & Johnson (JNJ) and Elan (ELN) also has a financial stake in the drug. Eli Lilly (LLY) is also developing solanezumab, an antibody against beta amyloid, a suspected underlying contributor to the disease's development.
News For PFE;JNJ;ELN;LLY From The Last 14 Days
Check below for free stories on PFE;JNJ;ELN;LLY the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | all recent news | >>
August 27, 2014
06:42 EDTLLYEli Lilly initiated with a Buy at Deutsche Bank
Target $71.
06:42 EDTPFEPfizer initiated with a Buy at Deutsche Bank
Subscribe for More Information
August 26, 2014
09:07 EDTLLYEli Lilly announces Jardiance available in U.S. pharmacies
Subscribe for More Information
08:01 EDTPFEPfizer, Merck to collaborate on study evaluating anti-cancer combination regimen
Subscribe for More Information
August 25, 2014
08:27 EDTJNJJanssen Affiliate Cilag acquires Covagen, terms not disclosed
Subscribe for More Information
07:03 EDTJNJVIVUS acquires patents from Janssen Pharmaceuticals
VIVUS (VVUS) announced the acquisition of a group of patents from Janssen Pharmaceuticals (JNJ) covering uses of topiramate as monotherapy and in combination with other pharmaceutical agents to treat a variety of medical conditions. Janssen has agreed to dismiss the lawsuit it brought against VIVUS on August 22, 2014 in the U.S. District Court for the District of Delaware. VIVUS will pay a one-time upfront fee and a royalty to Janssen on Qsymia product sales for an assignment of these topiramate-related patents owned by Janssen. VIVUS has an option to buy out the royalty for a predetermined amount.
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
07:12 EDTLLYEli Lilly announces results from pivotal UNCOVER studies for ixekizumab
Eli Lilly announces that its investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase 3 studies. Patients treated with both dosing regimens of ixekizumab had significantly greater levels of skin clearance compared to placebo and to etanercept at the 12-week endpoint. Skin clearance was measured by standard primary endpoints for psoriasis studies: the Psoriasis Area and Severity Index and the Static Physician Global Assessment. For patients treated with ixekizumab either every four weeks or every two weeks, between 78 to 90 percent of patients achieved at least a 75 percent reduction in PASI score at 12 weeks. Additionally, 31 to 41 percent of these patients achieved PASI 100, or clear skin, at week 12. For comparison, between 5 to 7 percent of patients treated with etanercept in the UNCOVER-2 and 3 studies achieved PASI 100. Adverse events were comparable for patients receiving ixekizumab in the 12-week, randomized control portion across all three studies.
05:42 EDTJNJIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
August 20, 2014
08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
Subscribe for More Information
August 18, 2014
17:37 EDTLLYFDA grants tentative approval for Lilly, Boehringer Basaglar insulin
Subscribe for More Information
11:41 EDTPFE, LLY, JNJCubist 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.
1 | 2 | all recent news | >>

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