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Stock Market & Financial Investment News

News Breaks
November 21, 2012
10:20 EDTOREX, RHHBY, ARNA, GSK, AET, VVUS, PFEVIVUS rallies after Aetna revises obesity drug policy
In a Clinical Policy Bulletin revision dated November 20, 2012, Aetna (AET) specified criteria under which the insurer considers weight reduction medications as "medically necessary" for treatment of obesity. Aetna stated, "For members whose medical policies do not exclude weight reduction medications or services and supplies for or related to weight reduction programs, Aetna covers [the following] drugs under the medical benefit, not the pharmacy benefit." Among the medications that have been approved by the FDA for weight reduction which would be covered under its policy, Aetna listed Qsymia, marketed by VIVUS (VVUS), Belviq from Arena Pharmaceuticals (ARNA), Didrex from Pfizer's (PFE) Pharmacia unit, Roche's (RHHBY) Xenical, and GlaxoSmithKline's (GSK) Alli. Early session strength in shares of VIVUS and Arena has been attributed to Aetna's policy revision, and shares of Orexigen Therapeutics (OREX), which is developing a weight loss treatment that is being considered by the FDA for approval, have also moved higher. In early morning trading, VIVUS advanced $1.58, or 15.27%, to $11.93, Arena gained 20c, or 2.24%, to $9.13 and Orexigen added 30c, or 6.88%, to $4.66.
News For VVUS;ARNA;OREX;AET;RHHBY;PFE;GSK From The Last 14 Days
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December 12, 2014
05:52 EDTRHHBYRoche announces retirement of Genentech research head
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December 11, 2014
08:50 EDTAETAetna sees operating EPS highest in 1Q15
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December 10, 2014
17:04 EDTAETAetna sees FY15 operating EPS at least $6.90, consensus $7.17
Sees FY15 operating revenue at least $62B, consensus $61.68B. Guidance to be confirmed at investor conference in New York on December 11.
17:02 EDTAETAetna backs FY14 operating EPS $6.60-$6.70, consensus $6.68
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14:45 EDTAETDeal would block payments to health insurance companies, The Hill says
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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
14:22 EDTAETAetna updates clinical policy for H.P. Acthar Gel
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12:22 EDTRHHBY, 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.”
10:23 EDTGSKOn The Fly: Analyst Downgrade Summary
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09:10 EDTGSKARIAD takeover rumors rekindled, Independent says
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07:44 EDTPFE, GSK, RHHBYAmerican Association for Cancer Research to hold a symposium
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05:37 EDTGSKGlaxoSmithKline downgraded to Underperform from Neutral at BofA/Merrill
BofA/Merrill downgraded GlaxoSmithKline to Underperform citing a lack of pipeline catalysts and its belief the European pharma sector is close to fair value.
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.
13:32 EDTGSKEpizyme announces results for PRMT5 inhibitor
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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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06:47 EDTARNAArena says Teva files marketing authorization of Belviq in Israel
Arena Pharmaceuticals (ARNA) disclosed late Friday that Teva Pharmaceutical's (TEVA) local Israeli subsidiary, Abic Marketing Limited, has filed for marketing authorization of Belviq in Israel. In connection with the filing, Arena will receive a milestone payment of $250K.
06:45 EDTARNAArena says Eisai withdraws Belviq application in Canada
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06:44 EDTARNAArena Pharmaceuticals says 'small number' of Belviq labels incomplete
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