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News Breaks
March 13, 2014
11:59 EDTPFE, MYLMylan to launch generic Celebrex after Pfizer patent ruling
Earlier today, Mylan (MYL) confirmed that the United States District Court for the Eastern District of Virginia has ruled invalid a patent, United States Patent No. RE44,048, related to Pfizer's (PFE) Celebrex 50 mg, 100 mg, 200 mg and 400 mg capsules. Mylan was sued by G.D. Searle and Pfizer Asia Pacific for alleged infringement of this patent in connection with Mylan's Abbreviated New Drug Application, ANDA, for its generic version of Celebrex. Mylan expects to launch its generic version of Celebrex in May 2014, pending final approval of its ANDA by the U.S. Food and Drug Administration, FDA. Based on available information, Mylan believes it may be entitled to 180 days of shared generic market exclusivity on the 100 mg, 200 mg and 400 mg strengths, subject to the FDA's determination that the product qualifies for an award of exclusivity under the provisions of the Hatch-Waxman Act. Mylan shares are fractionally higher in mid day trading.
News For MYL;PFE From The Last 14 Days
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August 27, 2015
17:38 EDTPFES&P announces changes to S&P 500 index
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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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