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January 23, 2013
13:45 EDTBAYRY, BAYRY, BAYRY, CELG, CELG, CELG, LLY, LLY, LLY, ONXX, ONXX, ONXX, REGN, REGN, REGN, SNY, SNY, SNYLeerink's biotech analyst hosts a luncheon meeting
Biotech Analyst Liang discusses the ongoing ASCO GI Cancer Symposium, physician impressions of the new Phase 3 data on CELG’s Abraxane and LLY’s Ramucirumab, as well as market dynamics for new agents in colorectal cancer such as Zaltrap and Stivarga at a Luncheon Meeting being held in San Francisco on January 25 at 2 pm.
News For BAYRY;CELG;LLY;ONXX;REGN;SNY From The Last 14 Days
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November 18, 2014
15:48 EDTSNYGenzyme, Isis present KYNAMRO data at AHA meeting
Genzyme, a Sanofi (SNY) company, and Isis Pharmaceuticals (ISIS) announced that new two-year data from a phase 3 long-term extension study of KYNAMRO injection was presented at a scientific session at the annual American Heart Association meeting. In the study, a retrospective analysis showed that patients treated with KYNAMRO for a mean of two years had a significant reduction in Major Adverse Cardiovascular Events compared to two years prior to therapy. The rate of MACE in patients treated with KYNAMRO for two years were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with KYNAMRO. In this analysis, MACE were identified in 62% of patients during two years prior to KYNAMRO treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with KYNAMRO.
12:16 EDTSNYSanofi to host seminar on New Medicines
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07:34 EDTCELGCelgene presents long-term OTEZLA data at ACR/ARHP meeting
Celgene announced that results from long-term efficacy and safety analyses of OTEZLA from the open-label phase of two PALACE phase III clinical trials were presented at the 2014 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting in Boston. OTEZLA is the Company’s oral, selective inhibitor of phosphodiesterase 4, approved by the U.S. FDA for the treatment of adult patients with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In PALACE 1, 84 percent of patients who completed one year of 30 mg twice daily therapy continued to receive OTEZLA at two years. Improvements in efficacy measures observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, among patients receiving OTEZLA 30 mg twice daily, the ACR20 response rate was 65.3 percent. ACR50 and 70 response rates were 34.0 percent and 19.6 percent, respectively, at week 104. Similar findings were observed in PALACE 4. In this trial, nearly 84 percent of DMARD-naïve patients who completed one year of OTEZLA 30 mg twice daily monotherapy continued to receive OTEZLA at two years. At week 104, among patients treated with OTEZLA 30 mg twice daily monotherapy, an ACR20, 50 and 70 response was reached by 61.4 percent, 40.7 percent and 19.2 percent of patients, respectively. In both PALACE 1 and PALACE 4, changes in other efficacy measures—including the HAQ-DI, which assesses improvements in physical function, and swollen and tender joint counts—were also generally sustained between weeks 52 and 104 with continued OTEZLA treatment. In PALACE 4, treatment with OTEZLA in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic arthritis, resulted in improvements in enthesitis and dactylitis that were sustained through 104 weeks of treatment.
05:43 EDTREGN, BAYRYRegeneron announces EYLEA injection approved for DME treatment in Japan
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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.
11:06 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
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07:16 EDTCELG, SNY, ONXXMilken Institute--Faster Cures to hold a conference
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November 16, 2014
14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
November 14, 2014
17:07 EDTCELGSoros Fund Management gives quarterly update on stakes
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14:53 EDTLLY, SNYCVS 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 EDTBAYRY, CELGAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
November 13, 2014
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.
09:33 EDTBAYRYZoetis could get bought by Bayer for $53/share, says Jefferies
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07:40 EDTSNYSanofi investor meeting timing tough in light of CEO ouster, Reuters says
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November 12, 2014
08:18 EDTBAYRYUBS to hold a conference
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08:13 EDTREGN, SNYBoston Biotech to hold a conference
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06:22 EDTBAYRYZoetis price target raised to $49 from $44 at Citigroup
Citigroup raised its price target for Zoetis (ZTS) shares to $49 after activist Pershing Square confirmed the accumulation of a 10% stake in the company. Citi thinks Pershing is interested in advocating for a sale of Zoetis, potentially to Valeant (VRX) if its bid for Allergan (AGN) fails. Citi believes others, including Bayer (BAYRY), could be interested in acquiring Zoetis. It keeps a Buy rating on the stock.
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