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Stock Market & Financial Investment News

News Breaks
July 16, 2014
10:36 EDTPFE, AGN, MYL, COV, VRX, AZN, MDT, ABTTreasury calls on Congress to halt inversion deals
Congress should "shut down" tax inversion deals, Treasury Secretary Jack Lew wrote in a letter to key members of Congress. Tax inversion deals have been embraced in recent months by a number of drug companies looking to lower their tax bills. WHAT'S NEW: In a letter to leaders of Congressional committees that deal with tax legislation, Lew said legislation to shut down tax inversion deal should be enacted immediately and made retroactive to May 2014. The Obama administration seeks to take comprehensive action to reform and simplify the U.S. tax system, but as it works to do that Congress should crack down on this loophole, Lew said. BACKGROUND: Tax inversions refer to an acquisition of one company, usually officially based in a country in Europe or elsewhere, by a U.S. company, following which the acquiring company becomes domiciled in the same country as the company that it bought. The switch has the potential to significantly lower the acquiring company's tax rate. ANALYST REACTION: In a note to investors earlier today, BMO Capital analyst David Maris wrote that anti-inversion rhetoric from the Obama administration may cause the environment for inversion deals to become "quite chilly." Although Congress is unlikely to act on this issue soon, the risk of legislation could make some companies think twice about paying high premiums for competitors they are acquiring in inversion deals, the analyst warned. Investors should be especially cautious about deals that are pending or have been recently announced, such as Mylan's (MYL) acquisition of Abbott’s (ABT) established products business announced on Monday, Maris wrote. Lew's letter will also hinder Valeant's (VRX) efforts to acquire Allergan (AGN), as the Treasury Secretary's statement will bolster Allergan's argument that Valeant's tax assumptions could be overly positive, according to the analyst. Maris has Outperform ratings on all the stocks mentioned except for Mylan, on which he has an Underperform rating. Another high-profile proposed deal in the pharmaceutical space that involved a potential inversion was Pfizer's (PFE) failed attempt to acquire AstraZeneca (AZN). Additionally, Medtronic (MDT) recently agreed to acquire Ireland's Covidien (COV). PRICE ACTION: In early trading, Mylan was little changed at $52.20, Abbott was fractionally higher to $41.25, Valeant was little changed at $120, Allergan traded fractionally lower at $164.30, Medtronic fell 1.7% to $62.48 and Covidien dropped 2% to $88.67.
News For MYL;ABT;VRX;AGN;MDT;COV;PFE;AZN From The Last 14 Days
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December 11, 2014
07:32 EDTMYLMylan launches generic version of Hikma Maple's Robaxin injection
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07:28 EDTAZNCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.
07:06 EDTMYLMylan launches generic version of Orapred ODT
Mylan announced the U.S. launch of its Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg. This product is the first generic version of Shionogi's Orapred ODT. Mylan received final approval from the FDA for its Abbreviated New Drug Application for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg, and was awarded 180 days of generic drug marketing exclusivity. This product is indicated as an anti-inflammatory or immunosuppressive agent for certain conditions; and also for the treatment of certain endocrine conditions, and for palliation of certain neoplastic conditions. Prednisolone Sodium Phosphate Orally Disintegrating Tablets had U.S. sales of approximately $19.9M for the 12 months ending September 30.
05:24 EDTABTAbbott IRIDICA now available in Europe
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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 EDTPFE, MYLMylan 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 EDTPFEPiper 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.”
09:31 EDTAGN, VRXZoetis drops after report of Valeant abandoning growth by acquisitions strategy
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09:10 EDTAZNARIAD takeover rumors rekindled, Independent says
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08:02 EDTAZNMoventig 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, AZNAmerican Association for Cancer Research to hold a symposium
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06:39 EDTVRXValeant to abandon growth by acquisitions strategy, Reuters says
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06:14 EDTAGNAllergan price target raised to $245 from $210 at Citigroup
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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.
11:30 EDTMYLLeerink generics pharmaceutical analyst holds analyst/industry conference call
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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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07:29 EDTAGNUBS to hold investor trip
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07:18 EDTAGNUBS to hold investor trip
2014 Annual West Coast Investor Trip travels on the West Coast on December 8-10.
07:05 EDTAZNInnocoll appoints Tony Zook as CEO
Innocoll AG (INNL) announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca (AZN), has been appointed CEO effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations.
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