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News Breaks
June 2, 2014
07:03 EDTPFE, MYLMylan settles patent litigation related to Celebrex capsules with Pfizer
Mylan (MYL) announced that it has entered into a settlement and license agreement with Pfizer (PFE) relating to Mylan's Abbreviated New Drug Application filed with the FDA for Celecoxib Capsules, 50 mg, 100 mg, 200 mg and 400 mg. This product is the generic version of Celebrex, which is 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. Under the terms of the agreement, Mylan will begin selling product at the earliest market formation, however in any case not later than December. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. Additionally, Mylan has appealed the decision by the United States District Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against the FDA. Mylan continues to believe that FDA seriously erred in its decision awarding one party eligibility for 180 days of exclusivity on Celecoxib, and will continue with this suit independent of the aforementioned settlement.
News For MYL;PFE From The Last 14 Days
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August 27, 2015
07:24 EDTPFEPfizer shares even more compelling after recent weakness, says Piper Jaffray
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06:55 EDTPFEHospira sees merger closing on or about September 3
Hospira (HSP) said in a regulatory filing that on August 21, Hospira and Pfizer (PFE) received clearance from the U.S. FTC, relating to the pending merger of Hospira with Perkins Holding Company, a wholly-owned subsidiary of Pfizer. All required regulatory approvals have now been secured, though the merger remains conditioned upon the expiration of a post-clearance waiting period in one foreign jurisdiction. Hospira expects the merger to close on or about September 3.
August 26, 2015
10:07 EDTMYLMylan initiated with a Buy at Standpoint Research
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07:32 EDTPFEPfizer launches Phase 3 trial of targeted therapy for breast cancer patients
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06:55 EDTMYLMylan shares may sell off on affirmative Perrigo deal vote, says BMO Capital
With Mylan (MYL) set to hold a shareholder vote on August 28 regarding its proposed acquisition of Perrigo (PRGO), BMO Capital analyst David Maris predicts that if the vote goes in Mylan's favor, he expects Perrigo shares to rise and Mylan shares to fall. Afterward, he feels added overhangs, such as Teva's (TEVA) and Abbott's (ABT) shareholdings and potential short-term selling by arbitrageurs, will come into play, further pressuring Mylan shares.
06:16 EDTPFEAlvogen to acquire product portfolio from Pfizer for US market
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05:58 EDTMYLPerrigo CEO says company is 'very active in M&A,' Bloomberg reports
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August 25, 2015
15:02 EDTMYLMylan says USPTO institutes IPR of two Copaxone patents
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14:40 EDTMYLTeva Copaxone patents to be reconsidered by regulators, Bloomberg says
14:16 EDTMYL, PFEMylan launches generic version of Pfizer's Zosyn Injection
Mylan (MYL) announced the U.S. launch of Piperacillin and Tazobactam for Injection USP, 3.375g Single-dose Vials, which is the generic version of Pfizer's (PFE) Zosyn Injection. This product is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of certain bacteria. Piperacillin and Tazobactam for Injection USP, 3.375g Single-dose Vials had U.S. sales of approximately $72.1M for the 12 months ending June 30, 2015, according to IMS Health. Mylan's launch of this product adds to the company's growing portfolio of more than 145 injectable products available to patients in the U.S. across a broad array of therapeutic categories including oncology, anti-infectives, anesthesia/pain management and cardiovascular.
13:22 EDTMYLMylan comments on 'misleading' Perrigo statements
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11:27 EDTMYLTeva to refrain from voting at Mylan special meeting
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August 24, 2015
12:57 EDTPFEFTC requires Pfizer to sell rights to four products as condition of buying Hospira
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08:16 EDTPFEBristol-Myers, Pfizer to present new data on Eliquis at ESC Congress 2015
Bristol-Myers Squibb Company (BMY) and Pfizer Inc. (PFE) announced that 22 abstracts will be presented at the ESC Congress 2015, to be held August 29 to September 2 in London, United Kingdom. The new data reinforce the Alliance's commitment to the ongoing evaluation of Eliquis in both the nonvalvular atrial fibrillation and venous thromboembolism patient populations. In addition, data from the AEGEAN study evaluating adherence among NVAF patients further extends the Alliance's commitment to patient care.
08:01 EDTPFEPfizer receives clearance from FTC for Hospira acquisition
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August 23, 2015
12:35 EDTPFEBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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August 21, 2015
15:22 EDTMYLMylan clarifies certain inaccuracies related to lowered condition to acquire Perrigo
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08:19 EDTMYLMylan to host special shareholder meeting
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08:01 EDTPFEPfizer says two Phase 3 Trumenba studies met primary endpoints
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August 20, 2015
11:24 EDTPFEPfizer says Ibrance application validated by EMA
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