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News Breaks
July 8, 2014
07:03 EDTTEVA, EGRXEagle Pharmaceuticals receives orphan drug designation for bendamustine HCl
Eagle Pharmaceuticals (EGRX) announced that the FDA has granted orphan drug designation to bendamustine hydrochloride, a ready-to-dilute concentrate solution for injection that will be administered by infusion over 10 minutes after dilution in 50mL of sodium chloride or a saline / dextrose mixture, for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin’s lymphoma. Pursuant to the orphan drug designation, Eagle is eligible to receive tax incentives and Prescription Drug User Fee Act fee savings, and believes it may receive seven years of marketing exclusivity. The currently marketed bendamustine HCI product, Treanda, which is manufactured by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries (TEVA), is a lyophilized powder requiring reconstitution and dilution in 500mL of saline or a sodium chloride / dextrose mixture before administration over 30 minutes for CLL and 60 minutes for NHL.
News For EGRX;TEVA From The Last 14 Days
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April 16, 2015
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
11:05 EDTEGRXEagle Pharmaceuticals price target raised to $65 from $51 at Cantor
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08:03 EDTEGRX, TEVATeva, Eagle announce NDA for bendamustine HCI accepted for filing
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April 13, 2015
13:25 EDTEGRXEagle Pharmaceuticals appoints Fibrocell CEO to board of directors
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07:56 EDTTEVAMylan, Teva, Perrigo price targets raised at JPMorgan
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April 9, 2015
09:51 EDTTEVAPerrigo did not expect Mylan takeover letter, CNBC's Faber reports
Perrigo (PRGO) did not expect the takeover letter it received from Mylan (MYL), CNBC's David Faber reports, citing sources. Perrigo will take its time in deciding what its next steps are, Faber added. Shares of Mylan are up 3% in early trading, which is being attributed, at least in part, to speculation the company could be a takeover target itself. Analysts this morning mentioned Teva (TEVA) as a potential acquirer of Mylan. Chatter this morning has Pfizer (PFE) also potentially interested in the EpiPen maker
08:30 EDTTEVAPotential bid for Mylan by Teva could provide profound synergies, says Cowen
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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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07:16 EDTTEVAMylan one of the cheapest names in Specialty Pharma, says JPMorgan
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April 7, 2015
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.
10:51 EDTEGRXEagle Pharmaceuticals announces new patent for low-sodium bendamustine
Eagle Pharmaceuticals announced that the United States Patent and Trademark Office has granted Patent No. 9,000,021 for the use of bendamustine for treating patients requiring restricted fluid and/or sodium intake. The patent issued today expires in March 2033. On February 13, 2015, Eagle submitted a New Drug Application to the FDA for bendamustine hydrochloride for administration in a 50mL admixture for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Eagle has requested Priority Review of the NDA; this product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval.
April 6, 2015
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
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