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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 The draft guidance titled, “Guidance for Industry, Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease,” explains the FDA’s current thinking about the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 FDA said it is seeking public comment on the draft guidance for 60 days.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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November 17, 2014
16:04 EDTLLYEli Lilly says empagliflozin tablets reduced A1C, body weight and abdominal fat
Empagliflozin tablets reduced hemoglobin A1C (a measure of average blood sugar over the past two to three months), body weight and several markers of abdominal fat in adults with type 2 diabetes, according to a new retrospective analysis of clinical trial data presented on behalf of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company at the 2014 Scientific Sessions of the American Heart Association in Chicago. Abdominal fat, also known as visceral fat, sits on or near vital organs. The study presented at AHA included analyses of two sets of adults with T2D treated with either empagliflozin or placebo. The first group consisted of 823 adults with high blood pressure who were treated for 12 weeks, while the second examined a pool of 2,476 adults from four different trials who were treated for 24 weeks. These randomized studies compared empagliflozin with placebo as an add-on to existing therapy, including metformin, metformin plus sulfonylurea, or pioglitazone with or without metformin. In both groups, treatment with empagliflozin significantly reduced A1C, body weight and several markers of abdominal fat compared with placebo. Changes in estimated total body fat did not reach statistical significance.
14:27 EDTPFEPfizer volatility flat into investor meeting
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11:06 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
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09:42 EDTPFEPfizer to host investor day
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09:22 EDTPFEOn The Fly: Pre-market Movers
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08:13 EDTPFEPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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07:16 EDTJNJ, PFEMilken Institute--Faster Cures to hold a conference
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06:43 EDTPFEAstraZeneca, Pfizer deal seen less likely after Merck transaction, Reuters says
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05:27 EDTPFEPfizer lowers FY14 Reported EPS view to $1.40-$1.49 from $1.50-$1.59
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05:23 EDTPFEPfizer forms strategic alliance with Merck KGaA
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November 14, 2014
16:21 EDTJNJOn The Fly: Closing Wrap
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14:53 EDTJNJ, LLY, PFECVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
07:14 EDTPFEAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
November 13, 2014
16:28 EDTJNJGeron announces global strategic collaboration with Janssen Biotech
Geron (GERN) announced that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses. Imetelstat is a modified oligonucleotide that is currently in early phase clinical development for myelofibrosis, or MF, and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome, or MDS, and acute myelogenous leukemia, or AML. Under the terms of the agreement, Geron will receive an initial payment of $35M due after the applicable waiting periods under the Hart-Scott Rodino Act and is eligible to receive additional payments up to a potential total of $900M for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. All sales will be booked by Janssen.
13:32 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.
11:54 EDTJNJJanssen announces FDA approved sNDA for INVEGA SUSTENNA
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10:44 EDTJNJMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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07:38 EDTPFEBloomberg Link to hold a conference
The Year Ahead: 2015 is being held in Washington, D.C. with a pre-conference dinner on November 13 followed by company presentations on November 14,
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