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News Breaks
March 24, 2014
13:30 EDTTEVA, MYLDistrict Court upholds Mylan's patents on performist inhalation solution
Mylan announced the United States District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist Inhalation Solution. Mylan previously sued Teva alleging that Teva's Abbreviated New Drug Application for this product infringed four Mylan patents covering Perforomist. After a full trial, the Court entered a judgment finding infringement of the patents-in-suit, rejecting Teva's defenses, and enjoining Teva from making, using, offering to sell, selling or importing the inhalation product described in Teva's ANDA. The Court's decision also prevents Teva's ANDA, which has yet to receive a tentative approval from the FDA, from receiving final approval prior to expiration of U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645, which cover Perforomist through June 2021.
News For MYL;TEVA From The Last 14 Days
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May 28, 2015
09:24 EDTMYLJefferies sees Pharma M&A continuing, lists 22 possible targets
Jefferies analyst David Steinberg believes the M&A wave in the Pharmaceuticals space that began in 2005 can continue as the key drivers remain largely intact. In a note titled "Who is Next? The Feeding Frenzy in Specialty Pharmaceuticals," Steinberg sees deals continuing amid cheap debt, the push for lower corporate taxes and investors rewarding many acquirers for their transactions. He points out there are now around 100 publicly traded Specialty Pharmaceutical companies following the recent life sciences IPO boom. Potential takeover targets, according to Steinberg, include Valeant (VRX), Shire (SHPG), Perrigo (PRGO), Zoetis (ZTS), Mallinckrodt (MNK), Jazz Pharmaceuticals (JAZZ), United Therapeutics (UTHR), Pacira (PCRX), Indivior, Insys Therapeutics (INSY), The Medicines Co. (MDCO), Depomed (DEPO), Spectrum (SPPI), KYTHERA (KYTH), Revance (RVNC), XenoPort (XNPT), Mylan (MYL), Akorn (AKRX), Impax (IPXL), Amphastar Pharmaceuticals (AMPH), Anacor (ANAC) and BioDelivery Sciences (BDSI).
09:07 EDTTEVAFTC, Teva reach $1.2B settlement over Provigil
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08:55 EDTTEVAXenon Pharmaceuticals sees IND for phase 1 trial of XEN801 in mid-2015
Xenon Pharmaceuticals (XENE) announced that Dr. Simon Pimstone, Xenon's President and CEO, will present a business update, including progress toward milestones, at the Jefferies Global Healthcare Conference on Tuesday, June 2. Xenon's partner Teva Pharmaceutical (TEVA) is conducting a randomized, double-blind, placebo-controlled Phase 2b clinical trial for TV-45070 in osteoarthritis. Results from the trial are now expected late in the second quarter or early in the third quarter of 2015. Xenon's partner Genentech, a member of the Roche Group (RHHBY), is currently conducting a Phase 1 clinical trial for GDC-0276, which is expected to complete patient enrollment in the second half of 2015. Xenon expects to file an investigational new drug equivalent application to initiate a Phase 1 clinical trial of XEN801, a stearoyl Co-A desaturase or SCD1 inhibitor for treatment of acne, in mid-2015. If supported by positive data from the Phase 1 trial, Xenon plans to initiate a proof-of-concept Phase 2 clinical trial in the second half of 2015. Xenon expects to file an investigational new drug application for Xenon's Nav1.6 sodium channel inhibitor for Dravet Syndrome in 2016.
06:11 EDTTEVA, MYLTeva takes 1.35% stake in Mylan, says 'ready to meet' on deal
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May 27, 2015
12:10 EDTTEVA, MYLTeva to sweeten offer for Mylan before July shareholder vote, NY Post says
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08:24 EDTTEVAFDA reports paragraph IV patent challenge received for Treanda
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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 19, 2015
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
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, 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
08:35 EDTTEVATeva says data present case for TEV-48125 progression to Phase III
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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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