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News Breaks
June 3, 2014
09:23 EDTTEVA, PFE, AMGN, JNJTeva acquisition a positive for Amgen, says Piper Jaffray
Piper Jaffray views Teva's (TEVA) acquisition of Labrys as a positive for Amgen (AMGN) since a potential competitor has stayed out of the hands of "formidable marketing wheelhouses" like Johnson & Johnson (JNJ) or Pfizer (PFE). Piper believes Amgen is in the lead for antibodies targeting CGRP receptor and Labrys is in the lead for antibodies targeting the CGRP ligand. It reiterates an Overweight rating on shares of Amgen.
News For AMGN;TEVA;JNJ;PFE From The Last 14 Days
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July 24, 2015
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.
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
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 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
10:15 EDTJNJThoratec downgraded to Market Perform from Outperform at Northland
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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
08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
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July 21, 2015
12:47 EDTAMGNPiper 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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08:04 EDTPFEPfizer launches Caltrate Bone & Joint Health supplement
Pfizer Consumer Healthcare announced the launch of Caltrate Bone & Joint Health, a 3-in-1, triple action product that delivers UC-II, an exclusive form of collagen, to support healthy cartilage and promote joint flexibility, calcium and vitamin D3, to nourish strong and healthy bones, and vitamin C and minerals to support collagen production for healthy bones and skin.
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.
July 17, 2015
08:38 EDTTEVALeerink puts 25% odds on Teva, Mylan deal within 12 months
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