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January 9, 2013
17:45 EDTTEVA, BIIBTeva files FDA petition to review safety of Biogen MS drug, Reuters reports
Teva (TEVA) has filed a petition with the FDA that asks the agency to have an outside panel evaluate the safety of Biogen's (BIIB) multiple sclerosis drug, BG-12, before approval, and if the FDA review is granted the drug's launch could be delayed, according to a Reuters report. Reference Link
News For TEVA;BIIB From The Last 14 Days
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July 2, 2015
07:11 EDTBIIBApplied Genetic Technologies to resume trading at 7:30 am EDT
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07:06 EDTBIIBBiogen, AGTC enter collaboration to develop gene therapies in ophthalmology
Biogen (BIIB) and AGTC (AGTC) announced a collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases. The collaboration will focus on the development of a portfolio of AGTC’s therapeutic programs, including both a clinical stage candidate and a pre-clinical candidate for orphan diseases of the retina that can lead to blindness in children and adults. The agreement also includes options for early stage discovery programs in two ophthalmic diseases and one non-ophthalmic condition, as well as an equity investment in AGTC by Biogen and a license agreement for manufacturing rights. Biogen will make an upfront payment in the amount of $124M to AGTC, which includes a $30M equity investment in AGTC at a price equal to $20.63 per share and certain prepaid research and development expenditures. Biogen will be granted a license to the XLRS and XLRP programs and the option to license discovery programs for three additional indications at the time of clinical candidate selection. Under the collaboration, AGTC is eligible to receive upfront and milestone payments exceeding $1B. This includes up to $472.5M collectively for the two lead programs, which also will carry royalties in the high single digit to mid-teen percentages of annual net sales. In addition, Biogen will make payments up to $592.5M across the discovery programs, along with royalties in the mid single digits to low teen percentages of annual net sales. Biogen obtains worldwide commercialization rights for the XLRS and XLRP programs. AGTC has an option to share development costs and profits after the initial clinical trial data are available, and an option to co-promote the second of these products to be approved in the United States. AGTC will lead the clinical development programs of XLRS through product approval and of XLRP through the completion of first-in-human trials. Biogen will support the clinical development costs, subject to certain conditions, following the first-in-human study for XLRS and IND-enabling studies for XLRP. Under the manufacturing license, Biogen will receive an exclusive license to use AGTC’s proprietary technology platform to make AAV vectors for up to six genes, three of which are in AGTC’s discretion, in exchange for payment of milestones and royalties. The transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, and is expected to close in the third calendar quarter of 2015.
July 1, 2015
08:30 EDTTEVATeva launches generic Aggrenox capsules in the U.S.
Teva announced the launch of generic Aggrenox capsules in the United States. Aspirin and extended-release dipyridamole capsules are used to lower the risk of stroke in people who have had a mini-stroke or stroke due to a blood clot. Aggrenox capsules had annual sales of approximately $457M in the United States, according to IMS data as of April.
08:11 EDTTEVATeva, Xenon provide update on TV-45070 Phase 2b study in OA pain
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08:04 EDTTEVATeva, Xenon Pharmaceuticals provide update on TV-45070 Phase 2b study
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08:01 EDTTEVATeva CEO: Pharma industry undergoing “very big shakeup,” Globes reports
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June 30, 2015
08:27 EDTTEVAPerrigo deal for Roxane would make Mylan fight harder, says Citi
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June 26, 2015
10:38 EDTTEVACourt revives lawsuit over GlaxoSmithKline Lamictal drug, Bloomberg reports
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05:21 EDTBIIBBiogen, Sobi announce EMA validates MAA for Alprolix
Biogen and Swedish Orphan Biovitrum AB, or Sobi, announced that the European Medicines Agency, or EMA, has accepted the Marketing Authorization Application, or MAA, of Alprolix, a recombinant factor IX Fc fusion protein product candidate for the treatment of hemophilia B. This validation signifies the initiation of the EMA’s review process. The MAA includes results from two global, Phase 3 clinical trials examining the efficacy, safety and pharmacokinetics of ALPROLIX for hemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and Kids B-LONG study for previously treated children under age 12.
June 25, 2015
13:59 EDTTEVATeva initiated with a Hold at HSBC
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12:59 EDTBIIBOptions with increasing implied volatility
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12:52 EDTTEVAEU to decide by July 29 on Mylan's bid for Perrigo, Reuters reports
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08:05 EDTTEVATeva, Active Biotech say patient enrollment finalized for CONCERTO trial
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June 24, 2015
11:16 EDTBIIBOptions with increasing implied volatility
Options with increasing implied volatility: WMB AMZN CMG BIIB VMW QLIK ISRG FB UA FFIV
08:04 EDTTEVATeva launches PainMatters.com to support ‘responsible pain management’
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June 23, 2015
14:16 EDTTEVABMO 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.
11:00 EDTBIIBOptions with increasing implied volatility
Options with increasing implied volatility:TRIP WPZ CMG BIIB WMB AMZN ISRG VMW
08:49 EDTTEVAMylan CFO to meet with Tel Aviv bourse head Wednesday, Reuters says
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07:55 EDTBIIBBiogen's Tysabri in SPMS a $1B-$2B opportunity, says Morgan Stanley
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June 21, 2015
19:53 EDTTEVAMylan CEO says Teva's 4.61% stake may be 'illegal,' Bloomberg reports
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