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News Breaks
June 17, 2014
08:05 EDTACT, TEVA, NVS, MYLTeva reaches settlement in NUVIGIL patent case
Teva (TEVA) announced that it has reached settlements with Sandoz (NVS), Actavis (ACT), Lupin and Apotex with respect to U.S. Patent 7,132,570 for Teva’s wakefulness product, NUVIGIL tablets. These settlements dismiss a pending appeal with the United States Court of Appeals for the Federal Circuit of a trial court decision that found the ‘570 patent to be valid and infringed. Teva has reached settlements with each of these companies, granting licenses to allow these parties to market their generic products 180 days after Mylan (MYL), the first generic company to file an abbreviated new drug application for the 50 mg, 150 mg, and 250 mg dosages of NUVIGIL. The settlements allow Actavis to launch generic 100 mg and 200 mg dosages in June 2016, and the others may launch these dosages 180 days after Actavis in the 100 mg and 200 mg dosage forms. Additional terms of the settlements are agreed by the parties to remain undisclosed. Previously, Teva settled its patent infringement litigation regarding the ‘570 patent against Mylan, which allowed Mylan to begin selling generic versions of 50 mg, 150 mg, and 250 mg NUVIGIL® under license beginning in June 2016, or earlier under certain circumstances.
News For TEVA;MYL;NVS;ACT From The Last 14 Days
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March 24, 2015
07:45 EDTTEVAFDA Pediatric Advisory Committee holds a meeting
The Committee discusses pediatric-focused safety reviews, as mandated by the FDA Safety and Innovation Act (FDASIA) for Eli Lilly's Cymbalta, Pfizer's Quillivant XR and Revatio, Johnson & Johnson's Risperdal, GlaxoSmithKline's Advair, HFA Altabax Ointment and Fluarix Quadrivalent, Supernus Pharmaceuticals' Oxtellar XR, Teva Pharmaceutical's Qnasl and Roche's Invirase. The Committee will also discuss the safety ongoing propriety of the humanitarian device exemption for the Medtronic Activa Dystonia Therapy and for the Liposorber LA-15 System in a meeting being held in Silver Spring, Maryland on March 24 at 8 am. Webcast Link
06:22 EDTTEVATeva appointment shows transformative M&A not off table, says Citigroup
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March 23, 2015
16:14 EDTACTPershing Square liquidates stake in Allergan
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16:01 EDTTEVAOptions Update; March 23, 2015
iPath S&P 500 VIX Short-Term Futures down 48c to 25.24 Option volume leaders: AAPL TSLA TWTR GILD CELG FB TSLA AMZN TEVA PBR according to Track Data.
12:10 EDTTEVATeva migraine drug data positive for Amgen, says Piper Jaffray
Piper Jaffray said the "positive" trial data Teva (TEVA) reported for its anti-CGRP antibody in migraines is another important validation for the class of drugs that is also being worked on by Amgen (AMGN), Eli Lilly (LLY) and Alder Biopharmaceuticals (ALDR). The firm said it thinks Amgen is one of the leaders in CGRP antibody space and reiterated its Overweight rating and $187 price target on Amgen shares.
09:45 EDTNVSUBS to hold a field trip
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09:03 EDTNVSLeerink analysts hold a meeting with a conference call hookup
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08:50 EDTTEVATeva reports TEV-48125 met endpoints in phase 2b study
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07:36 EDTACTPfizer should rise 'significantly' over next two years, says Jefferies
Jefferies analyst Jeffrey Holford told investors this morning that he expects shares of Pfizer (PFE) to appreciate "significantly" over the next two years. A survey of U.S. oncologists indicated the company's Ibrance drug will be used in 50% of first line hormonal therapy within one year, with off-label use in all lines of therapy including adjuvant, Holford noted. He thinks peak sales of the drug could top $13B, which is well above consensus. In addition, the analyst views Pfizer's Global Established Pharmaceutical business as being underappreciated by the market. Potential value creating options for the pharmaceutical giant include spinning off its GEP unit by 2017 and accretive acquisitions, with possible takeover targets being Shire (SHPG), Actavis (ACT), AstraZeneca (AZN) and GlaxoSmithKline (GSK), in the eyes of Holford. He added the stock to the firm's Franchise Picks list, which encompasses its best ideas. He also raised his price target for Pfizer to $45 from $42. The stock closed Friday up 10c to $34.25.
07:17 EDTACTAmerican Academy of Dermatology to hold annual meeting
73rd Annual Meeting of AAD is being held in San Francisco on March 20-24.
March 20, 2015
14:46 EDTACTNoven files patent infringement lawsuit against Actavis
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12:33 EDTNVSNovartis says CLEAR Phase IIb study met primary endpoint
Novartis announced results from the CLEAR study demonstrating that Cosentyx is significantly superior to Stelara, a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, USA. Cosentyx -- at a dose of 300 mg -- is the first and only interleukin-17A inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index 90 response, known as clear to almost clear skin at Week 16. PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara. In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara. The CLEAR study follows the pivotal Phase III FIXTURE study, which showed Cosentyx was superior to Enbrel.
07:41 EDTNVS, ACTAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
15:55 EDTNVSAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTNVSAmgen denied preliminary injunction for biologics against Novartis, Reuters says
March 18, 2015
16:13 EDTTEVAFibrocell Science appoints Keith Goldan as CFO
Fibrocell Science announced the appointment of Keith Goldan as senior VP and Chief Financial Officer, effective immediately. Prior to joining Fibrocell, Goldan served as CFO of two publicly traded companies. Most recently he served as SVP and CFO of NuPathe, which was acquired by Teva Pharmaceutical (TEVA) in 2014.
11:36 EDTTEVAIgnyta price target raised to $17 from $14 at Leerink
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10:08 EDTTEVAEagle Pharmaceuticals price target increased to $67 from $43 at William Blair
William Blair raised its price target on Eagle Pharmaceuticals to $67 from $43 citing its belief that the company can become profitable and have significant cash flow pending the approval of EP-3102. The company added that it view last week's FDA label change for Teva's (TEVA) Treanda as a positive for EP-3102 and that its new price target assumes 2016 launch and "reasonable" penetration for EP-3102.
08:50 EDTACTActavis price target raised to $373 from $286 at BMO Capital
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07:13 EDTTEVATeva volatility elevated, shares near four year high
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