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News Breaks
February 7, 2013
10:16 EDTLLY, PFE, ELN, JNJFDA 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 The draft guidance titled, “Guidance for Industry, Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease,” explains the FDA’s current thinking about the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 FDA said it is seeking public comment on the draft guidance for 60 days.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
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March 20, 2015
13:03 EDTPFEPfizer says oral tofacitinib meets primary endpoint in Phase 3 trials
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11:33 EDTLLYFly Review: Analysts correctly predict jump in Biogen shares
The shares of Biogen (BIIB) are rallying after the company reported results for a Phase 1b study of its Alzheimer's drug, BIIB-037. On March 18, as reported on that day by The Fly, RBC Capital predicted that the stock would rise after the results were published. A number of other firms were also upbeat on the stock ahead of the data release. WHAT'S NEW: Earlier this morning Biogen announced that the three milligram, six milligram, and ten milligram dose versions of its Alzheimer's treatment, aducanumab, had reduced the amount of amyloid plaque in the brains of Alzheimer's patients taking the drug by statistically significant amounts compared with those taking placebos. Beta amyloid is a protein that produces plaque in the brain. Scientists suspect that plaques in the brain are a cause of Alzheimer's. The cognitive decline of patients taking BIIB-037 was also significantly less than that of patients who were taking placebos, the company reported. PRE-EVENT CALLS: RBC Capital analyst Michael Yee predicted earlier this week in a note to investors that Biogen would report strong data for BIIB-037 and the stock should "work higher" after the data is unveiled. Alzheimer's patients taking the high dose of Biogen's BIIB-037 drug should exhibit a stabilization of cognition levels, Yee stated. Conversely, the cognition levels of patients taking the placebo should drop slightly, the analyst predicted. On March 13, in a note summarized by The Fly on that day, JPMorgan recommended buying Biogen shares ahead of the data release. Investors still incorporated a low probability of success for the drug, and the stock could rise further, the firm wrote. On March 19, in a note also published by The Fly, Credit Suisse wrote that Biogen's multiple could rise if the data on BIIB-037 was positive. It raised its price target on the name to $500 from $400. ANALYST REACTION: This morning, Barclays raised Biogen's price target to $500 from $435 following the company's report of "impressive" full results from the Alzheimer's study. Piper Jaffray analyst Joshua Schimmer also raised his price target for Biogen shares to $500 this morning, calling today’s BIIB-037 results "robust and impressive." Schimmer believes the trial showed a "consistent and dramatic" dose effect on both radiographic and clinical disease features and thinks the side effects "pale in comparison" to the drug’s efficacy. OTHERS TO WATCH: Eli Lilly (LLY) and Roche (RHHBY) are also currently developing similar Alzheimer's treatments. PRICE ACTION: In late morning trading, Biogen rose 7% to $464. The stock is up about 9% since Wednesday. Eli Lilly shares are up 1.6% to $75.40 this morning, while Roche rose 2.2% to $35. Reference Link
09:57 EDTLLYLeerink major pharma analyst holds an analyst/industry conference call
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09:01 EDTLLYEli Lilly up 2% to $75.75 in pre-market trading
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08:01 EDTLLYEli Lilly and Innovent Biologics announce strategic alliance
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07:55 EDTPFEAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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07:41 EDTPFE, LLYAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
11:00 EDTPFEPfizer participates in a conference call with Bernstein
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08:08 EDTLLYEli Lilly and Hanmi sign license and collaboration agreement
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March 18, 2015
17:09 EDTPFEPfizer CAPiTA published in New England Journal of Medicine
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12:48 EDTLLYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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07:46 EDTLLYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
March 17, 2015
05:35 EDTJNJJohnson & Johnson to invest $10M in UK government fund to fight dementia
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March 16, 2015
15:04 EDTJNJPharmacyclics says committee recommends unblinding after primary endpoint met
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07:27 EDTLLYBiodel BIOD-961 Phase 1 clinical trial meets primary efficacy endpoint
Biodel (BIOD) announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing Biodel's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management, or GEM, auto-reconstitution device, to Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit, which are marketed for the treatment of severe hypoglycemia. Study 6-101 was a randomized, single-center, double blind, six-period cross over study in 15 healthy volunteers who received each glucagon administered subcutaneously, or SC, and intramuscularly, or IM, in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic, or PK, profiles, the pharmacodynamic, or PD, glucose, responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. Study 6-101 was a Phase 1 randomized, single-center, double blind, six-period cross over study designed to evaluate the PK and PD profiles of BIOD-961 compared to marketed glucagon formulations manufactured by Eli Lilly and Novo Nordisk. BIOD-961 is a lyophilized glucagon formulation designed for use in the GEM auto-reconstitution device. On six separate dosing days, each subject received 1 mg of one of the test glucagons delivered either SC or IM. Fifteen normal, healthy subjects were randomized into the study and ten completed all dosings. The objectives of the study were to compare the PK profiles, the PD responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. These data will facilitate selection of an appropriate marketed glucagon to use as a comparator in the planned pivotal study, in which the primary efficacy endpoint for approval is to demonstrate PK and PD bioequivalence of BIOD-961 to one of the marketed comparators.
06:40 EDTPFEPCSK9 studies show potential improvement in heart health, WSJ says
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March 13, 2015
14:34 EDTJNJU.S. appeals court revives lawsuit over J&J's Benecol assertions
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07:23 EDTJNJJohnson & Johnson has a conference call hosted by JPMorgan
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March 12, 2015
16:39 EDTPFEPfizer says primary endpoint not achieved in Phase 4 study of Lyrica
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13:01 EDTLLYEli Lilly management to meet with SunTrust
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