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News Breaks
February 28, 2014
08:03 EDTSNY, ACTActavis confirms generic Multaq patent challenge
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Dronedarone Hydrochloride Tablets 400 mg. Actavis' ANDA product is a generic version of Sanofi's (SNY) Multaq, which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent AF. Sanofi and Sanofi-Aventis U.S. filed suit against Actavis on February 26 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA until Jan. 1, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
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November 17, 2014
09:32 EDTACTValeant says cannot justify paying $219 per share for Allergan
Valeant Pharmaceuticals (VRX) commented on the announcement that Allergan (AGN) and Actavis (ACT) have entered into a definitive agreement under which Actavis will acquire all outstanding shares of Allergan stock: "We have seen the announcement that Allergan and Actavis have made, and while we will review any such agreement in determining our course of action, Valeant cannot justify to its own shareholders paying a price of $219 or more per share for Allergan. Our business is performing extremely well as evidenced by our third quarter results, our expected strong fourth quarter, and our robust outlook for 2015, and I am confident in our continued ability to generate exceptional shareholder value. We will remain focused on delivering strong organic results and evaluating acquisition opportunities as we always have: prudently, in a disciplined manner, and in the best interests of our shareholders."
09:29 EDTACTActavis to host conference call
Conference call to discuss the acquisition of Allergan will be held on November 17 at 10:30 am. Webcast Link
09:24 EDTACTAllergan up over 5% to $209 after agreeing to be acquired by Actavis
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09:22 EDTACTOn The Fly: Pre-market Movers
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09:21 EDTACTActavis, Allergan transaction subject to approval of shareholders of both
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09:20 EDTACTActavis projects at least $1.8B in annual synergies from Allergan transaction
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09:18 EDTACTActavis sees free cash flow over $8B in 2016 following Allergan acquisition
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09:16 EDTACTActavis confirms deal to acquire Allergan for $219 in cash, stock
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09:15 EDTACTActavis confirms deal to acquire Allergan for $219 in cash and shares
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09:10 EDTACTActavis buying Allergan for $219 per share, CNBC reports
08:02 EDTACTActavis completes Durata Therapeutics tender offer
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07:16 EDTSNYMilken Institute--Faster Cures to hold a conference
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06:05 EDTACTActavis close to buying Allergan for over $64B, Bloomberg reports
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November 16, 2014
14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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14:02 EDTACTAllergan, Actavis move closer to deal, WSJ reports
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12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
November 14, 2014
16:58 EDTACTThird Point gives quarterly update on stakes
NEW STAKES: Alibaba (BABA), eBay (EBAY), Bed Bath & Beyond (BBBY), Shire (SHPG), and Parker Hannifin (PH). INCREASED STAKES: Actavis (ACT), Amgen (AMGN), EQT (EQT), Sensata (ST), Coca-Cola Enterprises (CCE). DECREASED STAKES: Williams Cos (WMB), Ally Financial (ALLY), Cheniere Energy (LNG), YPF (YPF), and FedEx (FDX). LIQUIDATED STAKES: AIG (AIG), T-Mobile (TMUS), Rackspace (RAX), Hertz (HTZ), and Citrix Systems (CTXS).
14:53 EDTSNYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
12:53 EDTACTOmega Advisors gives quarterly update on stakes
NEW STAKES: AerCap Holdings (AER), Nordic American Offshore (NAO), Melco Crown Entertainment (MPEL), Groupon (GRPN), and Ashland (ASH). INCREASED STAKES: QEP Resources (QEP), United Continental (UAL), Cabot Oil & Gas (COG), Actavis (ACT), and KAR Auction Services (KAR). DECREASED STAKES: Sprint (S), SandRidge Energy (SD), Sirius XM Holdings (SIRI), Kinder Morgan (KMI), and Transocean (RIG). LIQUIDATED STAKES: QUALCOMM (QCOM), Ocwen Financial (OCN), Freeport-McMoRan (FCX), Boston Scientific (BSX), and Capital One (COF).
07:32 EDTACTHayman Capital gives quarterly update on stakes
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