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News Breaks
May 13, 2013
07:49 EDTTEVA, IPXL, ENDP, ACTFDA 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.
News For IPXL;ACT;ENDP;TEVA From The Last 14 Days
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April 9, 2015
08:10 EDTTEVALeerink sees 70% chance of Mylan buying Perrigo with raised bid
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06:20 EDTTEVATeva bid for Mylan possible, but challenging, says Citigroup
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06:15 EDTTEVACiti does not see much strategic sense in Mylan, Perrigo deal
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05:49 EDTTEVAStocks with implied volatility movement; MYL TEVA
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April 8, 2015
16:22 EDTTEVAOn The Fly: Closing Wrap
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14:23 EDTTEVAAdditional bidders for Perrigo could emerge after Mylan offer, says Stifel
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13:07 EDTTEVAMylan bid for Perrigo makes strategic sense, says JPMorgan
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12:37 EDTTEVATeva downgraded to Hold from Buy at Standpoint Research
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10:01 EDTIPXLOn The Fly: Analyst Initiation Summary
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09:16 EDTACTActavis COPD drug Daliresp gets Paragraph 4 challenge
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08:05 EDTACTActavis price target raised to $348 from $328 at Leerink
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08:04 EDTACTActavis potential acquisition Rhythm initiates Phase 2b study of relamorelin
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07:34 EDTACTActavis initiates Phase 2b clinical trial of relamorelin
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07:16 EDTTEVAMylan one of the cheapest names in Specialty Pharma, says JPMorgan
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April 7, 2015
16:11 EDTIPXLImpax initiated with a Hold at Deutsche Bank
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15:24 EDTTEVATeva price target raised to $75 from $64 at BMO Capital
BMO Capital raised its EPS estimates for Teva (TEVA) and increased its price target on the stock to $75 from $64 on account of the expected launch of a treatment for chorea associated with Huntington’s disease in 3Q16 and a launch of a tardive dyskinesia drug in 3Q17 following the company's deal to buy Auspex (ASPX). The firm maintains its Outperform rating on Teva shares.
06:43 EDTIPXLImpax price target raised to $58 from $49 at Piper Jaffray
Piper Jaffray raised its price target for Impax Laboratories to $58 saying retail prescription data shows the company's generics business is "quietly performing well." Piper believes revenue from the generics segment could outperform its expectations for 2015 and also drive "significant"growth longer-term. It reiterates an Overweight rating on Impax.
April 6, 2015
07:09 EDTIPXLImpax price target raised to $56 from $48 at JMP Securities
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05:56 EDTTEVATeva battles possible generic Copaxone competitors, Globes reports
A citizen's petition has been filed by Teva with the FDA against possible generic competition to its MS treatment Copaxone beginning in September, Globes reports. The FDA has previously ruled that it was "too early" to discuss the matter. Reference Link
April 5, 2015
14:43 EDTACTActavis seeks FDA approval to market generic version of Gilead's Letairis
Actavis (ACT) on Friday, confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Ambrisentan Tablets, 5 mg and 10 mg. Actavis' ANDA product is a generic version of Gilead Science's (GILD) Letairis, which is a treatment for pulmonary arterial hypertension. Gilead Sciences and Royalty Pharma Collection Trust filed suit against Actavis on April 1, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. Patent number RE42,462. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Letairis and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. For the 12 months ending December 31, Letairis had global sales of approximately $595M, according to Gilead.
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