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News Breaks
August 7, 2014
12:06 EDTRDY, TEVATeva will continue to defend COPAXONE intellectual property rights
Teva (TEVA) confirmed that it has received the first paragraph IV notice for its three-times-a-week COPAXONE 40 mg/mL product from Dr. Reddy’s Laboratories (RDY). Teva will continue to vigorously defend its COPAXONE intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Dr. Reddy’s within the 45 day period provided under the Hatch-Waxman Act. The filing of the lawsuit will trigger a 30 month stay of FDA approval of Dr. Reddy’s ANDA. COPAXONE 40 mg/mL is protected by two Orange Book patents that expire in 2030.
News For TEVA;RDY From The Last 14 Days
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April 17, 2015
15:37 EDTTEVAMylan options active after reports Teva weighing potential bid
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15:05 EDTTEVATeva weighing potential bid for Mylan, WSJ reports
Teva Pharmaceutical (TEVA) is weighing a takeover bid for Mylan (MYL), according to the Wall Street Journal, citing people familiar with the matter. This comes one week after Mylan made a $28.9B acquisition offer for Perrigo (PRGO), the Journal added. Reference Link
14:51 EDTTEVAMylan says fully committed to Perrigo bid after speculation on Teva interest
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14:48 EDTTEVAMylan says tie-up with Teva 'without sound industrial logic or cultural fit'
14:31 EDTTEVAMylan 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 EDTTEVAMylan jumps after Dow Jones says Teva considering bid
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14:21 EDTTEVATeva weighing potential bid for Mylan, Dow Jones says
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12:56 EDTTEVAFederal 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.
08:12 EDTTEVATeva pullback a buying opportunity, says Leerink
Leerink views yesterday's pullback in shares of Teva after generic Copaxone was approved as a buying opportunity. The firm notes Teva remains confident in its $5 earnings per share floor. Leerink views the company's outlook as "bright" and keeps an Outperform rating on the name.
08:00 EDTTEVATeva patent loss should move management to acquire Mylan, says Cowen
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April 16, 2015
16:02 EDTTEVAOptions Update; April 16, 2015
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15:40 EDTTEVAGeneric 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 Mylan’s (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.
13:42 EDTTEVATeva shares defended at Evercore ISI
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12:37 EDTTEVAMomenta confirms Glatopa approval, to receive $10M payment
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12:35 EDTTEVASandoz receives FDA approval for Glatopa as generic competitor to Copaxone
Sandoz, a Novartis (NVS) company, announced the U.S. approval of Glatopa, the first generic version of Teva's (TEVA) Copaxone 20 mg/ml one-time-daily multiple sclerosis therapy. Glatopa, developed in collaboration with Momenta (MNTA) and produced entirely in the U.S., is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging features consistent with MS.
12:35 EDTTEVAFDA denies Teva attempt to block generic Copaxone
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06:16 EDTTEVAFormer Teva CEO appointed to position of CEO at Ovid Therapeutics
Ovid Therapeutics, a privately held biopharmaceutical company focused on developing therapies for rare and orphan diseases of the brain, appointed Dr. Jeremy Levin as CEO. Levin has served as Chairman of Ovid since 2014 and will continue to serve in this role. Most recently, Levin served as CEO of Teva.
April 15, 2015
19:34 EDTTEVAVIVUS files patent infringement lawsuit against Teva
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April 14, 2015
08:03 EDTTEVATeva, Eagle announce NDA for bendamustine HCI accepted for filing
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April 13, 2015
07:56 EDTTEVAMylan, Teva, Perrigo price targets raised at JPMorgan
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