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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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July 6, 2015
12:22 EDTMYLMylan jumps after Bloomberg report of new Teva bid
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12:18 EDTMYLTeva planning to raise Mylan bid to $86-$88/share, Bloomberg reports
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July 2, 2015
18:37 EDTPFEViiV, Desano enter strategic manufacturing agreement for Tivicay
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16:37 EDTPFEPfizer announces FDA acceptance for review of NDA for Xeljanz
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09:50 EDTMYLThe Medicines Co. drops 3.2% to $27.43 in early trading
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09:31 EDTPFEXRpro Sciences acquires assets related to ion channel platform from Pfizer
XRpro Sciences announced its acquisition of assets related to the ion channel biology platform from Pfizer that had previously been obtained as part of Pfizer's 2011 acquisition of Icagen. XRPro Sciences also acquired all of Pfizer's rights to the "Icagen" name and trademark. XRPro Sciences is re-launching the Icagen brand and will provide comprehensive services for ion channel and transporter drug discovery, combining Icagen's industry-leading scientific expertise and extensive portfolio of assays and cell lines with XRpro Sciences' proprietary, label-free X-ray fluorescence technology. The new Icagen will continue to operate out of the existing facility in Research Triangle Park, North Carolina in addition to the current XRpro Sciences Inc. site in Cambridge, Massachusetts. Pfizer scientists associated with the ion channel biology platform will transition to the new Icagen, ensuring continuity of their extensive scientific expertise.
July 1, 2015
16:00 EDTPFEOptions Update; July 1, 2015
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08:01 EDTMYLTeva CEO: Pharma industry undergoing “very big shakeup,” Globes reports
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June 30, 2015
08:27 EDTMYLPerrigo deal for Roxane would make Mylan fight harder, says Citi
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June 25, 2015
12:52 EDTMYLEU to decide by July 29 on Mylan's bid for Perrigo, Reuters reports
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June 24, 2015
13:23 EDTPFEPfizer says CDC committee votes to recommend MenB vaccine
Pfizer announced that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend that decisions to vaccinate adolescents and young adults 16 through 23 years of age against serogroup B meningococcal disease should be made at the individual level with healthcare providers. It added, "Specifically, the ACIP voted that a serogroup B meningococcal vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age." Pfizer's Trumenba is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. The ACIP recommendation will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval, Pfizer said.
11:02 EDTPFEPfizer lung cancer treatment granted FDA orphan drug designation
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09:07 EDTPFECAR-T cancer drug researchers seen as M&A targets, Bloomberg says
Juno Therapeutics (JUNO), Kite Pharma (KITE) and Bluebird Bio (BLUE) are trading well above their IPO levels as takeovers predictions have spurred interest and share increases for the developers of CAR-T gene therapies, said Bloomberg's "Real M&A" column, quoting Dimo Dimov, a professor at the University of Bath’s School of Management, as having said that companies such as Pfizer (PFE), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are "closely watching" the firms. Cellectis (CLLS), which is working with Pfizer on its own approach to CAR-T therapy, has said it wants to bring its therapy to market and doesn’t anticipate a sale, the report noted. Reference Link
June 23, 2015
14:17 EDTPFEGlycoMimetics to receive $20M payment from Pfizer
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14:16 EDTMYLBMO Capital sees strong fundamentals in Perrigo regardless of Mylan deal
Shares of Perrigo (PRGO) are trading higher intraday after BMO Capital Markets initiated coverage of the stock with an Outperform rating. The research firm is bullish on the shares regardless of whether Mylan's bid for the company succeeds, saying Perrigo is well-positioned to ride momentum in reduced-price healthcare. WHAT'S NEW: BMO Capital Markets' David Maris initiated coverage of Perrigo with an Outperform rating and a $246 price target. Maris cited the company's 70%-plus market share in store- and private-label brands, as well as its roughly $1B annual sales in the generics space. The analyst believes Perrigo will see continued benefit from larger trends driving consumer-centric healthcare and the curtailing of medical costs. WHAT'S NOTABLE: BMO Capital Markets noted that two upcoming Tysabri-related events are not accounted for by the Street, giving rise to a "significant" undervaluing of the shares. Mylan (MYL) has submitted multiple unsolicited offers for Perrigo, and while the likelihood of the deal seems low given Perrigo's numerous rejections and Teva's (TEVA) 4.61% blocking stake in Mylan. BMO Capital remarked that a failed deal should see "limited downside" for Perrigo. There could certainly be near-term volatility if a Mylan agreement doesn't materialize, but the analyst was confident in the well-positioned company's ability to deliver on both earnings per share and cash flow. PRICE ACTION: Shares of Perrigo are up nearly 2% in afternoon trading. The company saw a nearly 25% leap following Mylan's initial offer on April 8, though it has since dipped from that high.
14:01 EDTPFEPfizer announces enrollment of first patient in RESET study
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09:53 EDTPFEPfizer management to meet with FBN Securities
Meeting to be held in New York on June 25 hosted by FBN Securities.
08:49 EDTMYLMylan CFO to meet with Tel Aviv bourse head Wednesday, Reuters says
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07:25 EDTPFEPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
06:01 EDTMYLPerrigo initiated with an Outperform at BMO Capital
BMO Capital analyst David Maris started Perrigo (PRGO) with an Outperform rating and $246 price target. Maris calls shares "significantly undervalued" on a fundamental basis and sees limited downside risk should Mylan (MYL) remove its unsolicited bid for the company.
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