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Stock Market & Financial Investment News

News Breaks
March 7, 2014
12:25 EDTBIIB, BIIB, BAX, BAX, ALNY, ALNY, NKTR, NKTR, SGMO, SGMO, SHPG, SHPG, CSL, CSL, PFE, PFE, NVO, NVOPiper Jaffray's healthcare analysts hold an analyst/industry conference call
Analysts, along with Dr. Powell, Director of the Hemophilia Treatment Center at UC Davis Health System, review the current treatment paradigm for Hemophilia A and Hemophilia B on an Analyst/Industry conference call to be held on March 7 at 1 pm.
News For BIIB;BAX;ALNY;NKTR;SGMO;SHPG;CSL;PFE;NVO From The Last 14 Days
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December 10, 2014
07:38 EDTPFEMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
December 9, 2014
12:22 EDTSGMO, BAX, NVO, BIIB, ALNY, PFE, SHPGPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
10:32 EDTPFEPfizer says in talks with FDA on path forward for Mylotarg
Pfizer announced the presentation of encouraging early- and late-stage data from clinical studies across several hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and chronic myeloid leukemia. Among the highlights are results from several investigator-led, large, randomized studies evaluating the antibody-drug conjugate MYLOTARG in select adult AML populations. Research was presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, December 6-9. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology, said “In particular, we are encouraged by the significant clinical evidence emerging from large randomized trials, such as AML-19 and ALFA-0701, demonstrating a positive impact of MYLOTARG when added to standard first-line treatment for patients with acute myeloid leukemia. We are engaging in discussions with the U.S. FDA and other health authorities to determine the best path forward for MYLOTARG. In addition, we plan to initiate an expanded access protocol for the therapy by the end of 2014 in the United States in patients with relapsed or refractory acute myeloid leukemia for whom there are no other treatment options.”
10:23 EDTSHPGOn The Fly: Analyst Downgrade Summary
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08:02 EDTNKTRMoventig approved in EU for opioid-induced constipation
Nektar (NKTR) reported partner AstraZeneca (AZN) announced that MOVENTIG has been granted Marketing Authorisation by the European Commission for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxative. MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist to be approved in the European Union.
07:44 EDTPFE, NKTRAmerican Association for Cancer Research to hold a symposium
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06:38 EDTALNYAlnylam to host conference call
Conference call to discuss Phase 1 data from ALN-AT3, in development for the treatment of hemophilia will be held on December 9 at 8 am. Webcast Link
05:47 EDTALNYAlnylam reports poisitve initial results for ALN-AT3
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05:38 EDTSHPGShire downgraded to Neutral from Buy at BofA/Merrill
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December 8, 2014
13:32 EDTPFEPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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07:29 EDTNKTRUBS to hold investor trip
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07:18 EDTNKTRUBS to hold investor trip
2014 Annual West Coast Investor Trip travels on the West Coast on December 8-10.
07:11 EDTSGMOSangamo presents new data for Vivo Protein Replacement Platform
Sangamo announced the presentation of new preclinical data from its proprietary programs for the treatment of lysosomal storage disorders and Shire-partnered hemophilia program. These studies demonstrate the broad applicability of Sangamo's In Vivo Protein Replacement Platform for the potentially curative treatment of such diseases. The data presented at ASH from Sangamo's proprietary IVPRP applications demonstrated the efficient production, secretion and tissue uptake of functional iduronate-2-sulfatase and alpha-L-iduronidase, enzymes that are deficient in the LSDs, Hunter and Hurler's disease, respectively. Data were also presented from Sangamo's partnered program with Shire that demonstrated that therapeutic levels of Factor IX, the human clotting factor that is deficient in hemophilia B, could be generated in a dose-dependent manner in non-human primates. There were no significant alterations in circulating albumin levels. Studies in mice also demonstrated stable Factor IX production from Sangamo's IVPRP for over 1 year.
December 7, 2014
13:13 EDTALNYAlnylam files clinical trial application for ALN-CC5
Alnylam Pharmaceuticals announced that it has filed a Clinical Trial Application, CTA, with the U.K. Medicines and Healthcare products Regulatory Agency, MHRA, to initiate a Phase 1/2 clinical trial with ALN-CC5, a subcutaneously administered investigational RNAi therapeutic targeting complement component C5 for the treatment of complement-mediated diseases. As per the CTA filing, the intended clinical study of ALN-CC5 will be performed in normal human volunteers and, then, in patients with paroxysmal nocturnal hemoglobinuria, PNH. Following approval of the CTA, the company expects to initiate the Phase 1/2 study in early 2015, with initial data expected to be reported in mid-2015. In addition, Alnylam scientists presented new pre-clinical data at the 56th Annual Meeting of the American Society of Hematology. Amongst other reported research findings, new data showed an up to 99.2% knockdown of serum C5 and up to 96.2% inhibition of serum hemolytic activity in non-human primates, NHPs, with continued dosing for over seven months.
December 5, 2014
13:41 EDTSHPGShire to host research and development day with a conference call hookup
Research and Development meeting to be held in New York on December 10 at 8 am. Webcast Link
10:22 EDTPFEBristol-Myers call activity attributed to takeover speculation
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10:05 EDTPFEBristol-Myers jumps 2% amid talk of potential Pfizer bid
Shares of Bristol-Myers (BMY) are up in early trading amid chatter of a potential takeover bid from Pfizer (PFE). The stock is up $1.26 to $60.15. Bristol's market capitalization stands around $99B, less than twice that of Pfizer's $200B. A Jefferies analyst last week called Mylan (MYL) the most likely takeover target for Pfizer. Pfizer is "highly motivated" to buy a foreign company using its overseas cash and Mylan looks like the most likely target, Jefferies analyst Jeffrey Holford wrote.
09:56 EDTPFERumor: Bristol-Myers strength attributed to takeover speculation
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08:39 EDTALNYAlnylam to host research and development day
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