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News Breaks
October 5, 2012
10:38 EDTRHHBY, REGNCompounding linked to new round of contamination, NY Times says
A deadly meningitis outbreak is being linked to a steroid drug being contaminated by fungus at the New England Compounding Center, according to a New York Times report. The report noted that the center has a history of problems, including past FDA warnings cautioning it against opening sterile vials of Roche's (RHHBY) Avastin. The Fly notes that Regeneron Pharmaceuticals' (REGN) Eylea competes with Avastin as a treatment for Wet Macular Degeneration. Reference Link
News For RHHBY;REGN From The Last 14 Days
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October 20, 2014
07:19 EDTRHHBYIBC Life Sciences to hold a conference
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07:16 EDTREGNAmerican Academy of Ophthalmology to hold annual meeting
AAO Annual Meeting 2014 is being held in Chicago on October 18-21.
07:11 EDTRHHBYAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTRHHBY, REGNAmerican Society of Human Genetics to hold annual meeting
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07:06 EDTRHHBYNewLink announces worldwide license agreement for NLG919 development
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07:04 EDTRHHBYRoche approval would be positive for TESARO, says Jefferies
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07:02 EDTREGNRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
October 17, 2014
09:06 EDTREGNAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
07:07 EDTREGNRegeneron announces EYLEA results from NIH study
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October 16, 2014
14:47 EDTRHHBYRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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13:13 EDTRHHBYRoche considers submitting Ebola test for emergency use approval, WSJ says
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09:35 EDTRHHBYDiplomat announces contract to distribute Esbriet
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08:36 EDTREGNRegeneron Genetics Center announces new collaborations and appointments
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05:58 EDTRHHBYRoche sees FY14 core EPS targeted to grow ahead of sales
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05:56 EDTRHHBYRoche reports 9 month revenue CHF34.76B vs. CHF34.87B last year
Roche CEO Severin Schwan said: “Demand for our products is strong in both divisions and we are well on track to reach our full-year targets. We have had positive news from our product pipeline, including study results for Perjeta in breast cancer and a new combination therapy with Zelboraf in melanoma. The InterMune acquisition has also strengthened our portfolio with a new medicine, Esbriet for idiopathic pulmonary fibrosis, which has now been approved by the FDA. In Diagnostics, growth continues to be driven by the immunodiagnostics business and we have strengthened our molecular diagnostics portfolio with a new generation of testing systems.”
October 15, 2014
15:45 EDTRHHBYFDA approves Esbriet to treat idiopathic pulmonary fibrosis
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October 14, 2014
11:23 EDTRHHBYBIND Therapeutics and The Conference Forum hold a conference
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October 8, 2014
11:31 EDTRHHBYFDA grants priority review for Genentech's Lucentis
Genentech, a member of the Roche Group (RHHBY), announced that the U.S. FDA has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7M Americans. The FDA confirmed action date is February 6, 2015. The sBLA was submitted August 7 to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy. If approved by the FDA, Lucentis could be the first eye medicine available for diabetic retinopathy patients. The submission is based on results of the RISE and RIDE Phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with Lucentis at two years compared to patients treated with sham injections. Benefits of Lucentis treatment were maintained during year three of treatment. The safety in the RISE and RIDE Phase III trials was consistent with previous studies.
10:55 EDTRHHBYLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
07:19 EDTRHHBYCBI to hold a conference
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