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Stock Market & Financial Investment News

News Breaks
May 3, 2013
08:00 EDTAMGN, AMGN, SNY, SNY, GENZ, GENZ, TEVA, TEVAFDA to hold a joint committee meeting
Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee is being held to discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. The meeting will be held at FDA Silver Spring, Maryland offices on May 3 at 8 am. Webcast Link
News For AMGN;SNY;GENZ;TEVA From The Last 14 Days
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July 24, 2015
14:20 EDTSNYSanofi drops 0.4% to $53.32 after FDA makes announcement on Praluent
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14:20 EDTSNYFDA approves Regeneron, Sanofi cholesterol-lowering treatment
The announced the approval of Praluent injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. Praluent is marketed by Sanofi-Aventis (SNY) and Regeneron (REGN). Shares of Regeneron remain halted.
12:44 EDTAMGNAmgen announces FDA approval of expanded Kyprolis indication
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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
11:59 EDTTEVALeerink's specialty pharma/generics analyst has analyst/industry conference call
Specialty Pharmaceuticals/Generics Analyst Gerberry discusses the strengths and weaknesses of TEVAís preliminary responses to the IPR challenge on Copaxone 40mg, the likely outcomes for the Copaxone 40mg patent challenge and the perspectives on recent updates in the Jazz Pharmaceuticals' Xyrem patent case on an Analyst/Industry conference call to be held on July 27 at 11 am.
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 EDTTEVAPaulson 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
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 EDTTEVATeva 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 EDTTEVAMylan, Teva lower after Stitching looks to thwart hostile deal
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08:34 EDTTEVAMylan foundation exercises call option to 'level playing field'
08:33 EDTTEVAMylan foundation says shareholders at risk of Teva takeover
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July 22, 2015
10:06 EDTTEVAAbbott CEO says supportive of Mylan pursuit of Perrigo
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09:30 EDTTEVAAbbott CEO says 'pretty alligned' with Mylan so far
July 21, 2015
12:47 EDTSNY, AMGNPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
11:49 EDTAMGNNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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07:12 EDTAMGNAmgen's Repatha granted marketing authorization by EC
Amgen announced that the European Commission, or EC, has granted marketing authorization for Repatha, or evolocumab, the first proprotein convertase subtilisin/kexin type 9, or PCSK9, inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.
July 20, 2015
10:26 EDTTEVALeerink's specialty pharma/generics analyst has analyst/industry conference call
Specialty Pharmaceuticals / Generics Analyst Gerberry, along with MEDACorp Specialists Michael Belliveau, PhD and Shashank Upadhye, JD, discuss the strengths and weaknesses of TEVA's preliminary responses to the IPR challenge on Copaxone 40mg, the likely outcomes for the Copaxone 40mg patent challenge and perspectives on recent updates in the JAZZ Xyrem patent case on an Analyst/Industry conference call to be held on July 22 at 2 pm.
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