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News Breaks
June 26, 2013
05:55 EDTPFE, PFE, PFE, DNA, DNA, DNA, MACK, MACK, MACK, AMGN, AMGN, AMGN, IMGN, IMGN, IMGN, RHHBY, RHHBY, RHHBYIBC Life Sciences to hold a summit
8th Annual Next Generation Protein Therapeutics Summit is being held in San Diego, California on June 26-28.
News For PFE;DNA;MACK;AMGN;IMGN;RHHBY From The Last 14 Days
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July 27, 2015
16:00 EDTPFEOptions Update; July 27, 2015
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15:03 EDTPFENotable companies reporting before tomorrow's open
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12:36 EDTPFEEarnings Watch: Pfizer shares nearly flat since last earnings report
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July 24, 2015
15:00 EDTAMGNBroader label for PCSK9 drug positive for Regeneron, Amgen, says Deutsche Bank
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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
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.
06:27 EDTRHHBYRoche CEO expects biosimilars in Europe by late 2017, Reuters reports
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05:46 EDTRHHBYRoche expects FY15 sales to grow low- mid-single digits
Expects FY15 core EPS to grow ahead of sales at constant exchange rates. Roche expects to further increase dividend in Swiss francs.
05:45 EDTRHHBYRoche reports 1H15 core EPS CHF 7.22 vs. 7.57 last year
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July 22, 2015
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.
07:05 EDTRHHBYOphthotech names Shima as Chief Scientific Officer, Bjarke as CCO
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July 20, 2015
07:33 EDTRHHBYInternational AIDS Society to hold a conference
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05:13 EDTRHHBYRoche expands HIV Global Access Program
Roche announced an expansion to the HIV Global Access Program to include early infant HIV diagnostic testing for low and middle income countries. Roche, in partnership with the Joint United Nations Programme on HIV/AIDS, or UNAIDS, the Clinton Health Access Initiative, or CHAI, UNITAID, the U.S. President's Emergency Plan For AIDS Relief, or PEPFAR, and the Global Fund to fight AIDS, TB and Malaria, is committed to working with the Diagnostics Access Initiative by providing state-of-the-art solutions to achieve the 90-90-90 goal set forth by UNAIDS. Announced in 2014, the HIV Global Access Program is Roche's most recent addition to the AmpliCare Initiative, which launched in 2002 in South Africa.
July 16, 2015
16:05 EDTAMGNAmgen announces Phase 2 trial results evaluating Blincyto
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16:00 EDTPFEOptions Update; July 16, 2015
iPath S&P 500 VIX Short-Term Futures down 1.17 to 16.52 Option volume leaders: NFLX AAPL BAC FB F INTC C EBAY AMZN GM JPM MU PFE BABA JD X
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