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News Breaks
July 16, 2014
07:59 EDTMDT, AGN, ABT, PFE, PRGO, ABBV, MYL, COV, VRX, SHPG, AZNTreasury Secretary urges Congress to take action on tax inversions
Treasury Secretary Jack Lew, in a letter to Senate Finance Committee Chairman Ron Wyden and others, urged Congress to take action to address the "urgent issue" of tax inversions, which Lew said "function to hollow out the U.S. corporate income tax base." Lew noted that President Obama proposes to ensure that companies cannot change their tax domicile without a change in control of the company. According to Lew, several senators have "put companies on notice that any transaction that takes place after early May will not have the desired effect of lowering future U.S. tax liabilities." Tax inversions are a particularly significant issue in the pharmaceutical industry. Companies that have recently proposed transactions that involve an inversion component or have been linked to potential transactions include Pfizer (PFE), AstraZeneca (AZN), Mylan (MYL), Abbott (ABT), Shire (SHPG), AbbVie (ABBV), Allergan (AGN), Valeant (VRX), Perrigo (PRGO), Medtronic (MDT) and Covidien (COV). Reference Link
News For PFE;AZN;MYL;ABT;SHPG;ABBV;AGN;VRX;PRGO;MDT;COV From The Last 14 Days
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April 8, 2015
11:32 EDTPRGO, MYLMylan proposes to acquire Perrigo for $205 per share
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11:31 EDTMYL, PRGOPerrigo halted for volatility after jumping 7% to $176.42
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11:29 EDTMYL, PRGOMylan proposes to acquire Perrigo for $205 per share
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08:56 EDTPRGOPerrigo's ANDA for equivalent of Mallinckrodt's Exalgo approved by FDA
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07:24 EDTMDTNeurotechnology Industry Organization to hold a conference
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07:16 EDTMYLMylan one of the cheapest names in Specialty Pharma, says JPMorgan
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06:06 EDTAZNInovio selected by DARPA to lead $45M Ebola prevention program
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05:30 EDTABBVEnanta announces data on regimens containing protease inhibitors paritaprevir
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April 7, 2015
16:12 EDTAZNRegulus up 5% after RG-125 selected as clinical candidate by AstraZeneca
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16:12 EDTAZNRegulus RG-125 selected as clinical candidate by AstraZeneca
Regulus Therapeutics (RGLS) announced the selection of RG-12, a GalNAc-conjugated anti-miR targeting microRNA-103/107, or miR-103/107, for the treatment of Non Alcoholic Steatohepatitis, or NASH, in patients with type 2 diabetes/pre-diabetes, as a clinical candidate by AstraZeneca (AZN) under the companies' strategic alliance to discover, develop and commercialize microRNA therapeutics. RG-125 is the first compound from the alliance to be selected for clinical development by AstraZeneca. In connection with the candidate selection, AstraZeneca will pay Regulus $2.5M and will assume development of the program following acceptance of an Investigational New Drug application. In the near term, Regulus and AstraZeneca plan to submit key preclinical data on the RG-125 program to be presented at a scientific meeting later this year and expect to initiate a Phase I study of RG-125 in humans by the end of 2015.
10:19 EDTMYLHigh option volume stocks
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10:10 EDTSHPGJazz patent on Xyrem latest to be challenged by Kyle Bass
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08:10 EDTSHPGShire shares pricing in worst case scenario for patents, says Citigroup
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08:09 EDTPFEPfizer, Merck KGaA finalize agreement to co-promote XALKORI
Merck KGaA (MKGAY) and Pfizer (PFE) announced the finalization of the co-promotion agreement allowing the companies to co-promote Pfizer’s anaplastic lymphoma kinase inhibitor XALKORI. Under the agreement, XALKORI will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 in the United States, Canada, Japan and five European Union countries: France, Germany, Italy, Spain and the United Kingdom. In the U.S. and Canada, XALKORI will be co-promoted by EMD Serono, the U.S. and Canadian biopharmaceutical businesses of Merck KGaA. The second wave will begin in 2016 and includes China and Turkey. n 2015, Merck KGaA will receive a reimbursement associated with its promotion of XALKORI, followed by an 80% for Pfizer, 20% for Merck KGaA profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the U.S., Canada, Japan, France, Germany, Italy, Spain and the U.K. and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of XALKORI in countries where it is co-promoted with Merck KGaA.
07:32 EDTMYLMylan launches Norethindrone and Ethinyl Estradiol Tablets in U.S.
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07:31 EDTABBVBiogen to present data on neurological disease therapies at AAN meeting
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07:14 EDTAZN, PFEEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
07:13 EDTSHPGShire patent challenges only modest threat, says Jefferies
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07:02 EDTPFEGlycoMimetics updates on Pfizer's plans to initiate Phase 3 Rivipansel trial
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05:23 EDTSHPGShire reaches agreement with FDA on clear regulatory path for SHP465
Shire announces that it has reached an agreement with the FDA on a clear regulatory path for SHP465, an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder, or ADHD, in adults. Shire has agreed with the FDA to conduct a short-term efficacy and safety study in pediatric patients with ADHD. While Shire intends to pursue an adult indication, the FDA is requesting this additional pediatric data to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population. The company anticipates the clinical trial's first patient, first visit to take place in August 2015, with study completion targeted by the last quarter of 2016. Shire then expects to submit to the FDA by 2Q17 a Class 2 resubmission for approval of SHP465 as a treatment for ADHD in adults, which typically entails a 6-month review. Pending FDA approval, Shire anticipates launching the medicine in the second half of 2017. This update follows Shire's announcement on October 9, 2014, that it was engaging the FDA to determine the parameters of clinical data requirements in order to submit the Class 2 resubmission.
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