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News Breaks
May 30, 2014
09:17 EDTTEVA, PFE, MYLTeva receives favorable court decision regarding generic Celebrex capsules
Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. District Court for the Northern District of West Virginia denied a motion filed by Mylan (MYL) and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex 100, 200 and 400 mg capsules. On April 17, Teva entered into a settlement agreement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December, 2014, or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
News For TEVA;MYL;PFE From The Last 14 Days
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May 26, 2015
14:07 EDTPFEFDA approves request for updated package insert for Prevnar 13
The FDA approved a request from Pfizer's Wyeth Pharmaceuticals to supplement the biologics license application for Pneumococcal 13-valent Conjugate Vaccine, or Prevnar 13, to update the package insert to include data from the CAPiTA confirmatory efficacy study in adults. Reference Link
May 25, 2015
13:56 EDTMYLMylan responds to claims of EPS forecasting by Perrigo
Mylan (MYL) announced that it was asked by the Irish Takeover Panel to issue the following clarification and retraction in accordance with the Irish takeover rules, relating to its firm intention to make an offer to acquire Perrigo (PRGO). The clarification and retraction relates to certain forward-looking statements made by Mylan specifically during the "pendency of the offer" period concerning its long-stated target since 2012 of at least $6.00 in adjusted EPS by 2018. Subsequent to Mylan's May 5 earnings release, Perrigo submitted a complaint to the Irish Takeover Panel alleging that the reference to Mylan's $6.00 long-term target should be treated as a forward-looking profit forecast statement. Although Mylan's adjusted EPS goal has been a stated long-term target, and not a forecast of Mylan, at least during the offer period as it pertains to the Perrigo transaction, Mylan will no longer refer to that 2018 target or any other forward looking statements beyond 2015 that could constitute profit forecasts.
May 22, 2015
10:52 EDTPFEJPMorgan says Actavis shares cheap compared to peers
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May 21, 2015
07:37 EDTPFEPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
07:46 EDTPFEDeutsche Bank positive on potential Pfizer, GSK merger
Deutsche Bank analyst Gregg Gilbert believes a large foreign deal for Pfizer (PFE) may make sense and says a buyout of GlaxoSmithKline (GSK) could be "materially" accretive to earnings while improving the company's tax situation over time. Gilbert assumes a $60 per share buyout price for GlaxoSmithKline in a research note this morning titled "Introducing 'PfizerKline'". The stock closed yesterday up 2c to $44.68. Gilbert reiterates a Buy rating on Pfizer with a $41 price target. Shares ended yesterday up 23c to $34.21.
May 19, 2015
06:55 EDTPFEGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
06:08 EDTMYL, TEVAPerrigo CEO says would talk with Mylan, but at a higher price, Globes reports
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May 18, 2015
12:07 EDTMYLPerrigo: there is price point where would engage with Mylan, Bloomberg reports
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07:22 EDTMYLUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 18 at 8 am; not all company presentations may be webcasted. Webcast Link
06:58 EDTPFEActavis CEO says chances of Pfizer offer are 'unlikely', Financial Times says
Actavis (ACT) CEO Brent Saunders said the chances of Pfizer (PFE) making an offer are "incredibly unlikely," reports the Financial Times. Saunders said he has heard the gossip that Actavis could become a takeover target for a larger group, but he spends "zero time thinking about it." Reference Link
May 15, 2015
17:08 EDTTEVASoros Fund gives quarterly update on stakes
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14:51 EDTMYLMylan ANDA for generic version of Lexapro approved by FDA
The ANDA from Mylan (MYL) for a generic version of Escitalopram Oxalate, which is sold under the trade name Lexapro by Actavis' (ACT) Forest Labs, was approved by the FDA on May 14, according to a post to the regulator's site. Reference Link
09:31 EDTTEVA, PFE, MYLAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
08:12 EDTTEVATeva migraine treatment data positive, says Bernstein
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08:04 EDTTEVATeva to present new respiratory data at 2015 ATS conference
Teva Pharmaceutical Industries announced that three company-sponsored abstracts will be presented at the 2015 American Thoracic Society International Conference in Denver, Colorado on May 15-19.Data to be presented include a Phase III study examining the functionality, reliability, accuracy and overall patient satisfaction of ProAir RespiClick inhalation powder, which gained approval from the U.S. FDA in March 2015. ProAir RespiClick is now available by prescription and is indicated for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. Additional Phase III data to be presented include a late-breaking abstract highlighting an interim analysis of the long-term safety and efficacy of Teva’s investigational anti-IL-5 therapy, reslizumab, in patients with asthma and elevated blood eosinophils. A third abstract to be presented includes data from a dose-ranging study of fluticasone propionate multi-dose, dry-powder inhaler in adolescent and adult patients with asthma.
May 14, 2015
12:29 EDTPFEPfizer receives 'second request' from FTC regarding potential Hospira merger
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08:39 EDTPFETargacept, Catalyst Biosciences amend definitive merger agreement
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08:35 EDTTEVATeva says data present case for TEV-48125 progression to Phase III
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08:08 EDTPFEPfizer director Marc Tessier-Lavigne to step down from board
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07:44 EDTTEVAInternational Headache Society to hold a conference
17th Congress of the International Headache Society is being held in Valencia, Spain on May 14-17.
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