New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 7, 2013
10:16 EDTJNJ, LLY, PFE, ELNFDA 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 The draft guidance titled, “Guidance for Industry, Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease,” explains the FDA’s current thinking about the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 FDA said it is seeking public comment on the draft guidance for 60 days.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
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | 3 | all recent news | >>
July 27, 2015
15:03 EDTPFENotable companies reporting before tomorrow's open
Subscribe for More Information
12:36 EDTPFEEarnings Watch: Pfizer shares nearly flat since last earnings report
Subscribe for More Information
10:40 EDTJNJLeerink major pharma analyst holds an analyst/industry conference call
Subscribe for More Information
08:08 EDTLLYEli Lilly accepts recommendation to continue Phase 3 trial of evacetrapib
Subscribe for More Information
July 24, 2015
09:33 EDTLLYEli Lilly weakness creates buying opportunity, says Argus
Subscribe for More Information
July 23, 2015
17:51 EDTJNJJanssen submits sNDA to update label for Olysio
Subscribe for More Information
10:08 EDTLLYOptions with decreasing implied volatility
Subscribe for More Information
08:43 EDTLLYEli Lilly Alzheimer's data positive, says SunTrust
Subscribe for More Information
06:48 EDTLLYEli Lilly up 5.5% after reporting Q2 results, raising FY15 guidance
06:37 EDTLLYEli Lilly expands San Diego biotechnology center
Subscribe for More Information
06:33 EDTLLYEli Lilly raises FY15 EPS view to $3.20-$3.30 from $3.10-$3.20, consensus $3.18
Narrows FY15 revenue guidance to $19.7B-$20B from $19.5B-$20B, consensus $19.8B.
06:30 EDTLLYEli Lilly reports Q2 adjusted EPS 90c, consensus 74c
Subscribe for More Information
July 22, 2015
15:26 EDTLLYNotable companies reporting before tomorrow's open
Subscribe for More Information
10:59 EDTLLYBiogen drops after reporting data on Alzheimer's drug
The shares of Biogen (BIIB) are falling after the company released data on its Alzheimer's treatment candidate, aducanumab. Peer Eli Lilly (LLY) also reported data this morning on its own experimental Alzheimer's drug, solanezumab. BIOGEN: Biogen's data "does not inspire confidence," Piper analyst Joshua Schimmer wrote in a note to investors today. The 6 mg dose of the drug performed similarly to the 1mg dose, and was barely better than the placebo, the analyst stated. The cognitive and functional performance of the patients who took the 6 mg dose did not improve by a statistically significant amount, while the results of patients taking the other doses were "noisy,"Schimmer stated. Additionally, indications of excess fluid in the brain was observed in a significant number of patients, representing an additional problem for the treatment, the analyst believes. The data "is far from inspiring confidence" and makes the outlook for aducanumab "more speculative than ever," Schimmer contended. LILLY: Also this morning, Eli Lilly presented results from a pre-specified secondary analysis of several Phase 3 studies at the Alzheimer's Association International Conference. According to the company, the results suggest the treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer's disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point. Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period were preserved at the primary time point of 108 weeks within a pre-defined margin. Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period were also preserved at an additional time point of 132 weeks within a pre-defined margin.The differences at 108 weeks and at at 132 weeks remained statistically significant, the company said. PRICE ACTION: In morning trading, Biogen fell 3% to $397.43 while Eli Lilly shares rose 0.6% to $86.11.
10:15 EDTJNJThoratec downgraded to Market Perform from Outperform at Northland
Subscribe for More Information
10:05 EDTLLYEli Lilly gaps down, retraces, levels to watch
Subscribe for More Information
08:40 EDTLLYEli Lilly July weekly volatility elevated into Q2 and Alzheimer's drug data
Subscribe for More Information
08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
Subscribe for More Information
07:18 EDTLLYEli Lilly drops 3% to $83 after reporting Alzheimer's drug data
Subscribe for More Information
07:06 EDTLLYEli Lilly's solanezumab for Alzheimer's supports 'delayed-start' use
Subscribe for More Information
1 | 2 | 3 | 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