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February 13, 2013
05:55 EDTARIA, ARIA, REGN, REGN, ARE, ARE, ZLCS, ZLCS, PFE, PFE, ALNY, ALNY, VSTM, VSTM, SNTA, SNTABoston Biotech Conferences to host a conference
2012 CEO Conference, which was to be held on November 1-2 was rescheduled due to Hurricane Sandy, and is being held in New York on February 13-14.
News For ARIA;REGN;ARE;ZLCS;PFE;ALNY;VSTM;SNTA From The Last 14 Days
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December 11, 2014
10:13 EDTARIAOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: ARIAD (ARIA) downgraded at Credit Suisse... AbbVie (ABBV) downgraded to Equal Weight from Overweight at Morgan Stanley... Aimco (AIV) downgraded to Hold from Buy at KeyBanc... Anglo American (AAUKY) downgraded to Underperform from Neutral at Exane BNP Paribas... Approach Resources (AREX) downgraded at Sterne Agee... CommVault (CVLT) downgraded to Neutral from Outperform at Macquarie... Fifth Street Senior (FSFR) downgraded to Perform from Outperform at Oppenheimer... Harmonic (HLIT) downgraded to Neutral from Buy at Sidoti... Macerich (MAC) downgraded to Hold from Buy at Deutsche Bank... Newell Rubbermaid (NWL) downgraded to Outperform from Strong Buy at Raymond James... Olin Corp. (OLN) downgraded at Longbow... Penn West (PWE) downgraded to Underperform from Neutral at BofA/Merrill... Prudential plc (PUK) downgraded to Neutral from Buy at Nomura... Semiconductor Manufacturing (SMI) downgraded to Hold from Buy at Jefferies... Suncor (SU) downgraded to Neutral from Buy at BofA/Merrill... Talisman Energy (TLM) downgraded to Underperform from Neutral at BofA/Merrill... Thompson Creek (TC) downgraded to Hold from Buy at Deutsche Bank... Toll Brothers (TOL) downgraded to Underperform from Sector Perform at RBC Capital... Travelers (TRV) downgraded to Neutral from Buy at UBS... United Therapeutics (UTHR) downgraded at Credit Suisse... Vera Bradley (VRA) downgraded to Underperform from Neutral at Sterne Agee.
09:16 EDTARIAOn The Fly: Pre-market Movers
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08:05 EDTSNTAFDA Pediatric Oncologic Subcommittee to hold a meeting
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08:02 EDTARIAARIAD downgraded at Credit Suisse
As previously reported, Credit Suisse downgraded ARIAD to Underperform from Neutral. The firm said Iclusig launch metrics are weak and expects it to remain a last option for CML patients with specific resistant mutations or failure with other therapies. Price target lowered to $6 from $8.
08:02 EDTALNYAlnylam, The Medicines Co. announce initiation of Phase 1 ALN-PCSsc trial
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06:14 EDTARIAARIAD downgraded to Underperform from Neutral at Credit Suisse
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December 10, 2014
08:31 EDTPFETeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 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 EDTALNY, PFEPiper 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.”
09:10 EDTARIAARIAD takeover rumors rekindled, Independent says
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07:44 EDTPFEAmerican Association for Cancer Research to hold a symposium
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07:37 EDTARIAARIAD announces safety, efficacy follow-up data on Iclusig
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07:36 EDTARIAARIAD says Iclusig shows anti-leukemic activity in long-term follow up data
ARIAD Pharmaceuticals announced long-term follow up data from the Phase 1 trial of Iclusig, its approved BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. The study now shows that with a median follow-up of four years in chronic phase CML patients, Iclusig continues to demonstrate anti-leukemic activity in patients with limited treatment options and that responses have been maintained in CP-CML patients with 72 percent having a major cytogenetic response, 65 percent having a complete cytogenetic response and 56 percent having a major molecular response. Long-term safety data show that careful benefit-risk evaluations should guide decisions to use and maintain ponatinib therapy, particularly in patients who may be at increased risk for arterial thrombotic events. These data were featured in a poster presentation on December 8 at the 56th Annual Meeting of the American Society of Hematology taking place in San Francisco.
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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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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07:36 EDTARIAARIAD: Iclusig demonstrates anti-leukemic activity in patents in Phase 2 trial
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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.
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