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News Breaks
February 4, 2014
08:13 EDTACTActavis files ANDA to market Bendamustine Hydrochloride for injection
Actavis confirmed that it has filed an Abbreviated New Drug Application, or ANDA, with the FDA seeking approval to market Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial. Actavis' ANDA product is a generic version of Cephalon's Treanda, a treatment for chronic lymphocytic leukemia and non-Hodgkin's lymphoma. Cephalon filed suit against Actavis on January 31 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration certain of U.S. patents. 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.
News For ACT From The Last 14 Days
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April 17, 2014
16:18 EDTACTActavis to purchase four marketed products from Akorn and Hi-Tech Pharmacal
Actavis (ACT) announced that it has entered into agreements with Akorn (Akrx) and Hi-Tech Pharmacal (HITK) to purchase four currently marketed products and one product under development for cash consideration. The closing of the purchase agreements are contingent upon the consummation of Akorn's acquisition of Hi-Tech. Financial terms of the agreements were not disclosed. The agreements include three products marketed under Abbreviated New Drug Applications and one product marketed under a New Drug Application: Lidocaine/Prilocaine Topical Cream. The agreements also include one product under development.
16:08 EDTACTActavis, Forest Labs receive second request under Hart-Scott-Rodino from FTC
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April 16, 2014
10:00 EDTACTOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: A10 Networks (ATEN) initiated with a Buy at BofA/Merrill... Actavis (ACT) initiated with a Buy at Sterne Agee... Allergan (AGN) initiated with a Buy at Sterne Agee... Autohome (ATHM) initiated with a Neutral at Credit Suisse... BitAuto (BITA) initiated with an Outperform at Credit Suisse... Centene (CNC) initiated with a Neutral at UBS... Endo International (ENDP) initiated with a Buy at Sterne Agee... FS Investment (FSIC) initiated with an Overweight at Evercore... Hertz (HTZ) initiated with a Buy at Gabelli... Hilton (HLT) initiated with a Hold at Jefferies... Hospira (HSP) initiated with a Neutral at Sterne Agee... ImmunoGen (IMGN) initiated with a Buy at Canaccord... Impax (IPXL) initiated with a Neutral at Sterne Agee... Imperva (IMPV) assumed with a Neutral at Wedbush... Ingredion (INGR) initiated with an Outperform at Credit Suisse... Laredo Petroleum (LPI) initiated with an Outperform at RW Baird... Lpath (LPTN) initiated with a Buy at Canaccord... MediWound (MDWD) initiated with an Outperform at Oppenheimer... Medivation (MDVN) initiated with a Hold at Canaccord... NPS Pharmaceuticals (NPSP) assumed with a Buy at Canaccord... Nimble Storage (NMBL) initiated with a Market Perform at Raymond James... Regeneron (REGN) initiated with a Buy at Canaccord... Salix (SLXP) initiated with a Buy at Sterne Agee... Sibanye Gold (SBGL) initiated with an Outperform at Imperial Capital... Teva (TEVA) initiated with a Neutral at Sterne Agee... Wipro (WIT) assumed with a Hold at Jefferies.
08:34 EDTACTPiper Jaffray tech and biopharma analysts hold analyst/industry conference call
Technical Analyst Johnson, along with BioPharma Analysts, discuss the recent downturn in the biotech and specialty pharmaceuticals industries on an Analyst/Industry conference call to be held on April 17 at 10 am.
07:59 EDTACTActavis initiated with a Buy at Sterne Agee
Target $230.
April 15, 2014
10:21 EDTACTMylan announces settlement agreement for first-to-file Generess
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08:07 EDTACTActavis announces agreement related to Generess FE patent challenge litigation
Actavis (ACT) announced that it has entered into an agreement with Mylan (MYL) and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess. Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess® FE under its pending Abbreviated New Drug Application beginning on April 1, 2015. Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis' product beginning on October 1, 2015. Other terms of the settlement were not disclosed. Actavis remains in litigation with Lupin Ltd in connection with Lupin's pending ANDA for a generic version of Generess.
April 11, 2014
10:30 EDTACTActavis and Mylan shares recommended at Bernstein
April 9, 2014
10:06 EDTACTOn The Fly: Analyst Upgrade Summary
AmSurg (AMSG) upgraded to Buy from Hold at Cantor... CBOE Holdings (CBOE) upgraded to Buy from Neutral at BofA/Merrill... Carlyle Group (CG) upgraded to Outperform from Perform at Oppenheimer... FireEye (FEYE) upgraded to Buy from Hold at Topeka... Fortune Brands (FBHS) upgraded to Outperform from Neutral at Credit Suisse... Gray Television (GTN) upgraded to Outperform from Market Perform at Wells Fargo... Hibbett Sports (HIBB) upgraded to Overweight from Neutral at Piper Jaffray... LinkedIn (LNKD) upgraded to Buy from Hold at Topeka... Mallinckrodt (MNK) upgraded to Buy from Neutral at UBS... NXP Semiconductors (NXPI) upgraded to Strong Buy from Outperform at Raymond James... Nexstar (NXST) upgraded to Outperform from Market Perform at Wells Fargo... Penn National (PENN) upgraded to Overweight from Equalweight at Barclays... Philip Morris (PM) upgraded to Neutral from Reduce at Nomura... SAIC (SAIC) upgraded to Market Perform from Underperform at Wells Fargo... Sinclair Broadcast (SBGI) upgraded to Outperform from Market Perform at Wells Fargo... Yelp (YELP) upgraded to Buy from Fair Value at CRT Capital... Danaher (DHR) upgraded to Strong Buy from Buy at ISI Group... Quanex (NX) upgraded at BB&T... Omnicell (OMCL) upgraded at Craig-Hallum... Volkswagen (VLKAY) upgraded to Outperform from Market Perform at Bernstein... Magna (MGA) upgraded to Neutral from Sell at Citigroup... Actavis (ACT) upgraded to Positive from Neutral at Susquehanna... E-Trade (ETFC) upgraded to Neutral from Underperform at BofA/Merrill... AmerisourceBergen (ABC) upgraded to Outperform from Market Perform at FBR Capital... CONSOL (CNX) upgraded to Outperform from Neutral at Macquarie.
08:16 EDTACTActavis upgraded to Positive from Neutral at Susquehanna
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April 8, 2014
09:17 EDTACTActavis recommended on pullback at UBS
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07:08 EDTACTDrug deals increase to new high, Bloomberg says
M&A activity in the specialty pharmaceuticals industry has reached a new high after Mallinckrodt (MNK) recently bought Questcor (QCOR) for $5.6B, reported Bloomberg. Drugmakers from Actavis (ACT) to Valeant (VRX) are widening their suites of drugs through takeovers that immediately increased earnings with the help of lower corporate tax rates in countries such as Ireland. Reference Link

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