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News Breaks
February 14, 2013
12:15 EDTMYL, AZNAstraZeneca wins appeal to block generic Seroquel XR from Mylan, others
After a New Jersey district court ruled last March that AstraZeneca's (AZN) formulation patent protecting Seroquel XR extended release tablets was valid, the U.S. Court of Appeals for the Federal Circuit affirmed the lower court's ruling today. The lower court had also ruled that Anchen Pharmaceuticals, Osmotica Pharmaceutical, Torrent Pharmaceuticals and Mylan Pharmaceuticals (MYL) have infringed the Seroquel XR formulation patent, which expires in 2017. Reference Link
News For AZN;MYL From The Last 14 Days
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April 17, 2015
14:51 EDTMYLMylan says fully committed to Perrigo bid after speculation on Teva interest
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14:48 EDTMYLMylan says tie-up with Teva 'without sound industrial logic or cultural fit'
14:47 EDTMYLMylan says fully committed to stand-alone strategy, proposal to buy Perrigo
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14:32 EDTMYLMylan spikes higher, levels to watch
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14:31 EDTMYLMylan jumps after reports of potential bid from Teva
Shares of Mylan (MYL) jumped in afternoon trading after The Wall Street Journal and Bloomberg separately reported that Teva (TEVA) is exploring a takeover offer for the company. Both reports, which each cited sources, said Teva is evaluating a bid internally, but that the company has not made any formal offer as of yet. WHAT'S NOTABLE: In a note to investors this morning, analysts at Cowen said the approval of a generic version of Teva's 20mg Copaxone should spur management to make a value-creating decision to acquire Mylan. The firm also believes in Teva's skill in protecting its Copaxone asset and said now is the time to pursue aggressive strategic actions. Cowen reiterated its Outperform rating and $100 price target on Teva shares. ANOTHER TO WATCH: On April 8, Mylan announced that it delivered to Perrigo's Chairman on April 6 a non-binding proposal to buy the company for $205 per share in a combination of cash and Mylan stock. RBC Capital analyst Randall Stanicky said earlier this week he believed Perrigo may be engaging other companies in talks after Mylan made its offer public. Stanicky sees no clear competing bidder for Perrigo, however, and used a $230 per share takeover while analyzing possible deals. PRICE ACTION: In afternoon trading, Mylan shares rose 5.6% to $70.58, Teva added 3.7% to $65.53 and Perrigo fell 2.5% to $193.99.
14:23 EDTMYLMylan jumps after Dow Jones says Teva considering bid
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14:21 EDTMYLTeva weighing potential bid for Mylan, Dow Jones says
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12:56 EDTMYLFederal Circuit upholds Mylan's patents on Perforomist inhalation solution
Mylan (MYL) announced the United States Court of Appeals for the Federal Circuit upheld the validity and infringement of all four patents asserted by Mylan Specialty, L.P. protecting its Perforomist Inhalation Solution. The Court summarily affirmed the previous decision by the district court against Teva (TEVA). Today's decision prevents Teva from receiving final approval of its ANDA from the FDA prior to expiration of U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645. Those patents cover Perforomist until they expire in June 2021.
08:00 EDTMYLTeva patent loss should move management to acquire Mylan, says Cowen
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06:52 EDTAZNAstraZeneca granted FDA orphan drug designation for selumetinib
AstraZeneca announced that the FDA has granted orphan drug designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma, a rare disease in which cancer cells form in the tissues of the eye.
06:50 EDTAZNAstra reports median progression free survival of 13.5 months in AURA study
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05:53 EDTMYLStocks with implied volatility movement; XLNX MYL
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April 16, 2015
15:40 EDTMYLGeneric Copaxone approval a bit early but expected, says BMO Capital
BMO Capital believes FDA approval for Sandoz (NVS) and Momenta's (MNTA) generic 20mg Copaxone came slightly earlier than the market expected, but the firm added that the generic threat has been well expected. The firm added that it appears Mylanís (MYL) generic Copaxone hasn't been approved yet, leaving a "legitimate question" about why the FDA approved one generic and not the other. BMO thinks Teva's rate of conversion to the 40mg dose will help retain patients on the Copaxone franchise and it keeps an Outperform rating on Teva shares.
09:12 EDTAZNAstraZeneca granted orphan status for melanoma treatment
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07:58 EDTAZNAstraZeneca's MedImmune, Immunocore announce new collaboration agreement
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April 15, 2015
11:50 EDTAZNAstraZeneca initiated with a Buy at Societe Generale
09:02 EDTMYLRBC sees Akorn as possible play on Perrigo takeover interest
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07:41 EDTAZNEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 14, 2015
12:06 EDTAZNFDA panel accepts Onglyza's safety profile in 13-1 vote
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07:15 EDTAZNFDA Endocrinologic & Metabolic Drugs Advisory Committee holds a meeting
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