News Breaks |
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| September 4, 2012 |
| 08:14 EDT |  | IPXL, SNY | Impax reaches settlement with Sanofi relating to RENVELA and RENAGEL Impax Laboratories (IPXL) announced that it has reached agreement with Genzyme, a Sanofi company (SNY), to settle pending U.S. litigation with regard to the production and sale of generic formulations of RENVELA and RENAGEL. Under the terms of the settlement, Genzyme has agreed to grant Impax a license to sell a generic version of RENVELA tablets on March 16, 2014 or earlier under certain circumstances. Genzyme has also agreed to grant Impax a license to sell a generic version of RENVELA for oral suspension and of RENAGEL on September 16, 2014 or earlier under certain circumstances. The Company believes that it is the first to file an ANDA with a paragraph IV certification with respect to the sevelamer carbonate 800 mg tablet product, and expects to be entitled to 180-days of market exclusivity prior to the launch of additional ANDA products. Upon the agreed-upon launch dates, Global Pharmaceuticals, Impax’s generic division, intends to commercialize the products. RENAGEL and RENVELA are both indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. |
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News For IPXL;SNY From The Last 14 Days Check below for free stories on IPXL;SNY the last two weeks. |
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| May 23, 2013 |
| 08:18 EDT |  | SNY | Merrimack completes enrollement in a Phase 2 study of MM-121 with Sanofi
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| May 22, 2013 |
| 07:28 EDT |  | IPXL | UBS to host a conference Global Healthcare Services Conference is being held in New York on May 20-22 with webcasted company presentations to begin on May 22 at 8 am; not all company presentations may be webcasted. Webcast Link |
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| May 21, 2013 |
| 07:44 EDT |  | SNY | Sachs Associates to host a forum
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| May 20, 2013 |
| 17:26 EDT |  | SNY | Regeneron, Genentech, Sanofi enter into 'Zaltrap agreement'
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| 11:27 EDT |  | SNY | Appeals court reverses, remands patent ruling in Sanofi suit against Mylan, Teva
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| May 17, 2013 |
| 08:41 EDT |  | IPXL | Impax commenced shipment of authorized generic Zomig Impax (IPXL) announced that its generics division, Global Pharmaceuticals, commenced shipment of authorized generic Zomig tablets, as part of an agreement with AstraZeneca (AZN). Zomig is indicated for the treatment of migraine headaches in adults. According to IMS Health data, U.S. sales of Zomig tablets and orally disintegrating tablets were approximately $196M in the 12 months ended April 2013. |
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| 08:03 EDT |  | SNY | Sanofi reports positive topline results from pivotal Phase III Jakarta study
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| 05:18 EDT |  | SNY | Sanofi says JAK2 inhibitor for myelofibrosis met primary endpoint
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| May 15, 2013 |
| 15:16 EDT |  | SNY | Sanofi systemic sclerosis treatment designated for orphan drug status
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| 05:39 EDT |  | SNY | Sanofi, Regeneron announce patient enrollment in two Phase 3 trials
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| May 13, 2013 |
| 09:44 EDT |  | SNY | Several companies reportedly interested in buying Adcock Ingram, Globes says
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| 07:49 EDT |  | IPXL | FDA decision on Opana a modest positive for Impax, says Leerink Leerink views the FDA's denial of Endo's (ENDP) Citizen Petition as a modest positive for Impax (IPXL), which it notes is the sole holder of 180 day exclusivity on generic Opana. However, Leerink says upside for Impax will be limited as Actavis (ACT), Sandoz, and Teva (TEVA) have settlements to enter the market starting in June 2013 when Impax's 180-day generic exclusivity expires. |
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| 07:30 EDT |  | SNY | TechConnect to host a summit 2013 National Innovation Summit is being held in Washington, D.C. on May 12-16. |
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| May 10, 2013 |
| 11:48 EDT |  | SNY | Drugmakers to face pressure on U.S. prices, Reuters says
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