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News Breaks
April 23, 2014
04:55 EDTESALY, ESALY, PRXL, PRXL, WAG, WAG, COV, COV, PFE, PFE, SNY, SNY, AMGN, AMGN, CPB, CPB, JNJ, JNJ, MYL, MYL, LO, LOFood & Drug Law Institute to hold a conference
2014 FDLI Annual Conference is being held in Washington, D.C. on April 23-24.
News For ESALY;MYL;JNJ;CPB;AMGN;SNY;PFE;COV;WAG;PRXL;LO From The Last 14 Days
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July 24, 2015
12:27 EDTAMGNFDA approves expanded use of Kyprolis in multiple myeloma patients
The FDA announced that on July 24 the administration approved carfilzomib, or Kyprolis, marketed by Onyx Pharmaceuticals, an Amgen (AMGN) subsidiary, in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The revised labeling includes new Warnings and Precautions for VTE, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. The increased safety risks, including mortality, for elderly patients is described. Detailed safety information in the prescribing information was also updated for use of carfilzomib monotherapy. Reference Link
07:21 EDTSNYRegeneron, Sanofi say CHMP recommends Euro approval of Praluent treatment
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September. The CHMP opinion was based on the benefit-risk profile of Praluent, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. The U.S. Food and Drug Administration has set a target action date of July 24 for the Biologics License Application of Praluent. The safety and efficacy of Praluent have not been fully evaluated by any other regulatory authority.
07:18 EDTSNYRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:16 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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06:56 EDTMYLPaulson may play key role in Teva-Mylan-Perrigo drama, CTFN says
John Paulson's hedge fund, Paulson & Co., has upped its stake in Mylan (MYL) to 4.65%, which is below the threshold that would compel it to disclose its plans to the U.S. SEC but high enough for it to obtain standing before the Dutch Enterprise Chamber, which would hear any legal challenge to the "stichting" maneuver the company is employing to avoid a takeover by Teva (TEVA), said CTFN. The takeover fight is most likely headed for court in Amsterdam after Mylan's shareholder foundation exercised an option to acquire shares and Paulson's involvement is noteworthy since he teamed with Centaurus Capital in 2007 to thwart a stichting ploy used by Stork, the report noted. Reference Link
July 23, 2015
17:51 EDTJNJJanssen submits sNDA to update label for Olysio
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09:10 EDTAMGNAmgen submits NDA for Kyprolis in relapsed multiple myeloma
Amgen submitted a supplemental New Drug Application to the FDA for Kyprolis for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy. The sNDA is based on data from the global Phase 3 ENDEAVOR trial in which relapsed multiple myeloma patients treated with Kyprolis and dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade.
09:04 EDTMYLTeva says 'strongly disagrees' with Stichting stated analysis
Teva Pharmaceutical Industries (TEVA) issued the following statement regarding Stichting Preferred Shares Mylanís (MYL) decision to exercise its call option: "We strongly disagree with the stated analysis of Stichting Preferred Shares Mylan and its decision to exercise its call option, which is unwarranted, relies on false assumptions, and risks depriving Mylan stockholders and other stakeholders of the value inherent in a combination of Teva and Mylan. We continue to believe that our proposed transaction offers a compelling opportunity for value-creation and many other benefits for the stockholders, customers, patients, and employees of both companies. We are well advised on Dutch law, including the ability of Mylan stockholders to challenge this action in court, and are prepared to take the necessary actions at the appropriate time."
08:48 EDTMYLMylan, Teva lower after Stitching looks to thwart hostile deal
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08:48 EDTMYLMylan confirms exercise of full call option by independent foundation
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08:34 EDTMYLMylan foundation exercises call option to 'level playing field'
08:33 EDTMYLMylan foundation says shareholders at risk of Teva takeover
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July 22, 2015
10:15 EDTJNJThoratec downgraded to Market Perform from Outperform at Northland
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10:06 EDTMYLAbbott CEO says supportive of Mylan pursuit of Perrigo
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09:30 EDTMYLAbbott CEO says 'pretty alligned' with Mylan so far
09:07 EDTCPBOn The Fly: Pre-market Movers
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08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
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07:38 EDTCPBCampbell Soup revises long-term growth targets
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07:32 EDTCPBCampbell Soup raises FY15 adjusted EPS view to $2.43-$2.46 from $2.32-$2.38
Consensus is $2.38. Consistent with previous sales guidance, the company expects sales to decline by 1 percent, reflecting the negative impact of currency translation. Reflecting favorable gross margin performance and earlier-than-expected benefits from the previously announced cost reduction initiatives, Campbell now expects adjusted EBIT to decline -2 to -1 percent, compared to the previous guidance of being at the favorable end of the -7 to -5 percent range. The company expects adjusted EPS to be in the range of -1 to 0 percent, or $2.43 to $2.46 per share, compared to the previous guidance of being at the favorable end of the -5 to -3 percent range or $2.32 to $2.38 per share.
07:31 EDTCPBCampbell Soup now sees $75M in savings from cost reduction initiatives in FY15
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