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News Breaks
January 9, 2013
17:45 EDTTEVA, BIIBTeva files FDA petition to review safety of Biogen MS drug, Reuters reports
Teva (TEVA) has filed a petition with the FDA that asks the agency to have an outside panel evaluate the safety of Biogen's (BIIB) multiple sclerosis drug, BG-12, before approval, and if the FDA review is granted the drug's launch could be delayed, according to a Reuters report. Reference Link
News For TEVA;BIIB From The Last 14 Days
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July 23, 2014
10:02 EDTTEVAOn The Fly: Analyst Initiation Summary
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09:50 EDTBIIBBiogen says strategic bias still tuck-in acquisitions
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09:37 EDTBIIBBiogen says 'clearly' has considered tax inversion
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09:25 EDTBIIBBiogen sees Japan as an attractive growth opportunity for company
Says remains committed to SG&A leverage in 2014. Says guidance assumes Tecfidera EU uptake similar to U.S.
09:17 EDTBIIBOn The Fly: Pre-market Movers
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09:05 EDTBIIBBiogen says received letter from EU saying PLEGRIDY has been approved
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08:56 EDTBIIBBiogen still sees FY CapEx approximately $300M
Believes TECFIDERA is on track to become the leading MS product in the U.S. Says outside the U.S., demand for TECFIDERA has been broad; launch trajectories similar to experience in U.S. Continues to be in discussions with AIFA to resolve its dispute on Tysabri for February 2009-January 2013. Says FY guidance "meaningfully increased" due primarily to the  growth  of  TECFIDERA in the U.S. and the EU., the strength of our other MS therapies and clarity on the AIFA pricing matter. Comments from slides that will be presented on the Q2 earnings conference call.
08:10 EDTTEVADeutsche Bank hosts an analyst Specialty Pharma/Industry conference call
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06:50 EDTBIIBBiogen raises FY14 EPS to $12.90-$13.10 from $11.35-$11.45, consensus $11.53
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06:48 EDTBIIBBiogen reports Q2 Tecfidera revenue $700M; Reports Q2 Avonex revenue $774M
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06:47 EDTBIIBBiogen reports Q2 adjusted EPS $3.49, consensus $2.83
Reports Q2 revenue $2.42B, consensus $2.16B; Non-GAAP diluted EPS was benefited by approximately 15c, following the approval from an agreement with the Italian National Medicines Agency relating to Tysabri sales in Italy.
July 22, 2014
16:08 EDTTEVATeva initiated with a Buy at Deutsche Bank
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14:30 EDTBIIBBiogen technical remarks ahead of earnings
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July 21, 2014
08:11 EDTTEVAArena Pharma' subsidiary enters into agreement for Belviq with Teva subsidiary
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08:01 EDTTEVATeva completes acquisition of Labrys
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07:37 EDTBIIBBiogen July weekly volatility elevated into Q2 and outlook
Biogen July weekly call option implied volatility is at 55, August is at 34, October is at 36; compared to its 26-week average of 33 according to Track Data, suggesting large near term price movement into the expected release of Q2 on July 23.
July 16, 2014
08:48 EDTTEVATeva says ISS supports company's nominees, shareholders' meeting proposals
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July 15, 2014
11:13 EDTTEVAPerrigo retreats after analyst sees limited potential buyers
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06:28 EDTTEVAActivist shareholder says Teva to appoint new chairman, Reuters says
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July 14, 2014
08:04 EDTTEVATeva announces FDA acceptance of NDA filing for albuterol MDPI
Teva Pharmaceuticals Industries announced that the U.S. Food and Drug Administration has accepted for review the company’s new drug application for albuterol multi-dose dry-powder inhaler, an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents with asthma and exercise-induced bronchospasm. The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.
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