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News Breaks
March 7, 2014
14:18 EDTNVS, SNY, PFE, REGN, RHHBY, AMGNConcerns with PCSK9 class not seen with Regeneron drug, says Citigroup
Citigroup said its talks with Regeneron (REGN) indicate that the issues the FDA has noted with PCSK9 drugs have not arisen in the ongoing Phase 3 studies of Regeneron and Sanofi's (SNY) Alirocumab. Citi suspects the events described in filings by Regeneron and Sanofi might have been seen with PCSK9 inhibitors being developed by Amgen (AMGN), Pfizer (PFE), Novartis (NVS) or Roche (RHHBY). Citi also notes that neurocognitive side effects are known to be caused by statins and it is unclear whether the effects were seen with PCSK9 inhibitors when used alone or when combined with statins.
News For REGN;SNY;AMGN;PFE;NVS;RHHBY From The Last 14 Days
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February 19, 2015
05:31 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
05:31 EDTRHHBYExelixis announces acceptance of NDA for Genentech cobimetinib
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05:26 EDTRHHBYFDA grants Genentech cobimetinib priority review for combination use
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February 18, 2015
17:23 EDTREGNRegeneron reports positive results for Eylea injection in diabetic macular edema
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03:20 EDTREGNOn The Fly: Analyst Initiation Summary
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February 17, 2015
18:17 EDTAMGNJANA Partners gives quarterly update on stakes
NEW STAKES: NCR (NCR), Liberty Ventures (LVNTA), Solarcity (SCTY), Computer Sciences Corp (CSC), Salix (SLXP), and Applied Materials (AMAT). INCREASED STAKES: Hertz (HTZ), Valeant (VRX), Walgreens Boots Alliance (WBA), Rackspace (RAX), and HD Supply (HDS). DECREASED STAKES: AIG (AIG), Actavis (ACT), Charter (CHTR), AerCap (AER), and Energy Transfer Equity (ETE). LIQUIDATED STAKES: Equinix (EQIX), Cameron International (CAM), Dollar General (DG), QEP Resources (QEP), and Amgen (AMGN).
15:36 EDTPFETianyin JCM plans for FDA certification process
Tianyin Pharmaceutical (TPI) updated on the business and development at its Jiangchuan Macrolide Facility, or JCM, active pharmaceutical ingredients operation. In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's (PFE) and their subsidiaries in China, the company said. "This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets," Tianyin stated.
11:38 EDTSNYGenzyme reports publication of ENGAGE registration study results
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10:01 EDTAMGN, REGN, PFECVS says PCSK9 inhibitors could cost system $150B annually
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10:00 EDTREGNOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Box, Inc. (BOX) initiated with a Hold at Canaccord... Euronav NV (EURN) initiated with an Overweight at Morgan Stanley... GoPro (GPRO) initiated with an Outperform at Northland... M/A-COM (MTSI) initiated with a Neutral at BofA/Merrill... Macy's (M) initiated with an Underweight at Barclays... NetSuite (N) initiated with an Underperform at Exane BNP Paribas... Omega Healthcare (OHI) initiated with a Neutral at BofA/Merrill... Pandora (P) initiated with a Neutral at Macquarie... Pattern Energy (PEGI) coverage resumed with an Outperform at BMO Capital... Regeneron (REGN) initiated with an Outperform at Bernstein... Trovagene (TROV) initiated with an Overweight at Piper Jaffray... Vista Outdoor (VSTO) initiated with a Market Perform at Cowen.
06:35 EDTREGNRegeneron initiated with an Outperform at Bernstein
Target $475.
February 13, 2015
17:52 EDTAMGNThird Point gives quarterly update on stakes
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11:31 EDTNVSNovartis says heart failure medicine LCZ696 granted FDA piority review
Novartis announced that the U.S. FDA has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction. The designation accelerates the review of therapies that offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition[4]. For LCZ696 this reduces the total review time from 12 to 8 months, meaning the FDA could make a decision on approval in August 2015. The New Drug Application was submitted under the agency's Fast Track program and is based on results from the landmark PARADIGM-HF study, the largest ever conducted in heart failure, which showed LCZ696 was superior to ACE-inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization. Patients' reports of how well they felt were significantly better with LCZ696 than enalapril, whilst maintaining an acceptable safety profile. In the EU the Committee for Medicinal Products for Human Use has granted accelerated assessment to LCZ696.
10:28 EDTPFEPfizer announces FDA acceptance for review of NDA for ALO-02
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08:23 EDTNVS, AMGNPiper Jaffray biotech/healthcare analysts hold analyst/industry conference call
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08:19 EDTPFEAckman noncommittal on McDonald's rumors, Bloomberg reports
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February 12, 2015
16:20 EDTSNYGenzyme announces data from Phase 1b study for Niemann-Pick Type B
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15:12 EDTPFEJ&J Remicade appeal process could take years to resolve, says Wells Fargo
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08:52 EDTSNYSanofi's Genzyme reports Phase 3 results for Cerdelga
Genzyme, a Sanofi company, reported extension study data from its Phase 3 ENGAGE and ENCORE studies of Cerdelga, or eliglustat, a first-line oral therapy approved by the FDA and the European Commission for the treatment of certain adults with Gaucher disease type 1. Both extension studies demonstrated continued stability and/or improvements across established end points and published therapeutic treatment goals. ENGAGE is a phase 3, randomized, double-blind, placebo-controlled, multi-center tudy to investigate the efficacy and safety of eliglustat in adults with gaucher disease type 1. After 18 months, in the primary analysis period, improvements were seen across the following endpoints after 9 months on cerdelga: spleen size, platelet count, hemoglobin concentration, and liver volume. In the 9 month extension phase, patients who switched from placebo to eliglustat showed improvements similar to the eliglustat-treated patients during the primary analysis while the eliglustat-treated patients continued to show improvements during the 9 month extension period. There were no treatment-related discontinuations. ENCORE is a phase 3, randomized, controlled, open-label non-inferiority study comparing eliglustat to imiglucerase in gaucher disease type 1 patients stabilized on enzyme replacement therapy. After 24-months, the study, which met the primary analysis criteria for non-inferiority to imiglucerase, had a composite endpoint of each of the following parameters: spleen volume, hemoglobin concentration, platelet counts, and liver volume at 12 months. During the 12-month extension period, the patients who crossed over to eliglustat treatment from imiglucerase remained stable. Patients treated with eliglustat for 24 months also maintained stability of clinical parameters during the extension period. The most common adverse reactions -- ≥10% -- in the primary analysis periods of ENGAGE and ENCORE were fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. In both extension studies the majority of adverse reactions with Cerdelga were mild and transient, and consistent with those in the primary analysis periods. Most patients in both of the Phase 3 studies continue to receive Cerdelga in longer term extension periods. The majority of patients are now in their 4th or 5th year of treatment.
07:33 EDTPFEHospira not announcing FY15 projections due to recent merger argreement
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