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News Breaks
October 5, 2012
10:38 EDTREGN, RHHBYCompounding 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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January 28, 2015
08:07 EDTRHHBYRoche unit receives orphan status for alectinib
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05:49 EDTRHHBYRoche sees 2015 sales growth in low- to mid-single digit
Roche expects sales to grow low- to mid-single digit, at constant exchange rates for 2015. Core earnings per share are targeted to grow ahead of sales at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.
05:48 EDTRHHBYRoche reports 2014 core EPS CHF14.29 vs. CHF14.27 last year
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January 27, 2015
14:00 EDTRHHBYRoche to hold a meeting with a conference call hookup
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January 26, 2015
05:15 EDTRHHBYRoche receives FDA clearance for next generation cobas MRSA/SA test
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05:14 EDTREGNRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 23, 2015
08:17 EDTRHHBYRoche management to meet with JPMorgan
Meeting to be held in New York on January 29 hosted by JPMorgan.
07:39 EDTREGNRegeneron announces EYLEA Injection recommended for approval in EU
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January 21, 2015
10:16 EDTREGNLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
09:02 EDTRHHBYRoche's Ventana seeks FDA premarket approval for ALK IHC lung cancer assay
Roche Group member Ventana Medical Systems announced its FDA submission for premarket approval of the Ventana ALK CDx Assay. The companion diagnostic immunohistochemistry test is designed to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy that inhibits the ALK gene. This submission was the fourth and final module and application required by the FDA's PMA process.
January 16, 2015
16:36 EDTRHHBYMarket finishes week lower on continued oil, global growth worries
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06:21 EDTRHHBYRoche acquires Trophos for EUR120M plus contingent payments
Roche has agreed to acquire Trophos, a privately held biotechnology company based in Marseille, France. Trophos’s proprietary screening platform generated olesoxime, TRO19622, which is being developed for SMA – a rare and debilitating genetic neuromuscular disease that is most commonly diagnosed in children. Results from a pivotal phase II clinical trial with olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with the disease. These data were first presented in April 2014 at the annual meeting of the American Academy of Neurology. Under the terms of the agreement, Trophos’s shareholders will receive an upfront cash payment of EUR 120M, plus additional contingent payments of up to EUR 350M based on achievement of certain predetermined milestones.
January 14, 2015
10:30 EDTRHHBYHuman Longevity signs genome sequencing pact with Roche unit
Human Longevity announced a multi-year agreement with Genentech, a member of the Roche Group, to conduct whole genome sequencing of tens of thousands of de-identified samples from Genentech. HLI, using proprietary tools and unique expertise, will sequence genomes to 30x coverage and analyze the data. Financial details of the agreement were not disclosed.
06:36 EDTREGNRegeneron price target raised to $474 from $390 at Citigroup
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