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Stock Market & Financial Investment News

News For ACT;TEVA;ENDP;COV;ABT From The Last 14 Days
Check below for free stories on ACT;TEVA;ENDP;COV;ABT the last two weeks.
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April 23, 2014
11:17 EDTCOVCovidien management to meet with Needham
Meeting to be held in New York on April 30 hosted by Needham.
06:53 EDTCOVFood & Drug Law Institute to hold a conference
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April 22, 2014
10:00 EDTTEVAOn The Fly: Analyst Initiation Summary
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07:42 EDTTEVATeva initiated with a Buy at Jefferies
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April 21, 2014
11:33 EDTABTAward of $16M to Sanofi, Abbott for damages upheld on appeal
The Court of Appeals for the Federal Circuit affirmed a lower court ruling that Glenmark Pharmaceuticals infringed a patent related to the antihypertension drug Tarka that is owned by or exclusively licensed to Sanofi (SNY), Abbott Labs (ABT), and their related companies. In the prior case, Glenmark admitted infringement and the jury awarded $15.2M in lost profits and about $800K in price erosion damages. The appeals court affirmed the district court's jurisdiction in the matter, as well as its judgment and related rulings. Reference Link
09:21 EDTTEVAOn The Fly: Pre-Market Movers
HIGHER: Sarepta (SRPT), up 54% after announcing plans to to submit NDA for Eteplirsen by year end 2014. Shares of Prosnesa (RNA), another drugmaker working on a competing DMD drug, are up more than 12%... AstraZeneca (AZN), up 6% after the Sunday Times says that Pfizer (PFE) is considering a takeover bid for the company. Pfizer is up 1.2% following the report... Newmont Mining (NEM), up 8% after WSJ says the company and Barrick Gold (ABX) could resume merger talks as soon as today... Cbeyond (CBEY), up 39% after agreeing to be acquired for about $323M by Birch Communications... Momenta Pharma (MNTA), up 10.5% after the Supreme Court rejected Teva's (TEVA) bid to delay generic Copaxone... Nu Skin (NUS), up 5% after saying its China division will resume corporate-hosted business meetings... Micron (MU), up 4% after price target raised at Drexel Hamilton... DOWN AFTER EARNINGS: Acacia Research (ACTG), down 6%... athenahealth (ATHN), down 5.6%.
08:58 EDTACTImpax appoints G. Frederick Wilkinson as CEOActavis
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08:18 EDTTEVAMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
April 19, 2014
18:50 EDTTEVAMylan says Teva denied injunction seeking to prevent launch of generic Copaxone
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18:32 EDTTEVASupreme Court denies Teva stay in generic Copaxone case
Teva Pharmaceutical Industries announced that while the Chief Justice of the United States found that Teva had demonstrated “a fair prospect of success on the merits” in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808, he denied the company’s application to stay the Federal Circuit's decision due to the potential for the company to recover patent infringement damages. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis, RRMS, product, Copaxone 20mg/mL. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone. Teva previously prevailed in the District Court, which upheld the validity of nine Copaxone patents, including the ‘808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the COPAXONE patents that expire in May, while invalidating the ‘808 patent that is the subject of Teva’s now-granted certiorari petition. Any purported generic version of Copaxone would be required to obtain the approval of the FDA prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints in RRMS patients. The company is confident Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.
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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08:38 EDTTEVATeva settles patent ligitigation with Pfizer on Celebrex
Teva (TEVA) announced that its subsidiary Teva Pharmaceuticals USA, Inc. has entered into a settlement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December 2014 or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
April 16, 2014
13:54 EDTABTDanone slips after fresh dairy volume shrinks
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10:27 EDTENDPEndo International says AMS unit received FDA warning letter
In a regulatory filing, Endo International disclosed that as previously reported in Endo Health Solutions's Form 10-K filed with the SEC on March 3, in February 2014, the United States FDA conducted an inspection of the Minnetonka, Minnesota facility of American Medical Systems, AMS, a subsidiary of Endo International. Following such inspection, the FDA issued three observations on a Form 483 Notice of Inspectional Observations dated February 24. These observations, previously self-identified by AMS, were being addressed through a corrective action plan which AMS originally expected to complete beyond 2015. On April 14, AMS received a Warning Letter from the FDA, dated April 10. The Warning Letter relates to the same matters as identified in the Form 483 Notice. Specifically, the Warning Letter discusses observations related to process validation, risk analysis and corrective and preventive action procedures. The letter states that the corrective actions which AMS reviewed with the FDA on March 20, 2014 appear to be adequate, but it goes on to state that many of the actions have not yet been completed and will need to be validated in a follow-up inspection. AMS has 15 days to respond to the Warning Letter. AMS expects only limited related impact to its business at this time. The Minnetonka, Minnesota facility will continue to manufacture and ship products while AMS works with the FDA.
10:00 EDTTEVA, ACT, ENDPOn 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.
09:35 EDTABTAbbott: We have plenty of cash for M&A activity, not constrained on borrowing
09:15 EDTABTAbbott sees pace of EPS growth and sales to accelerate throughout FY14
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09:14 EDTABTAbbott sees Q2 EPS 50c-52c, consensus 51c
Sees Q2 sales growth in low to mid single digits, consensus $5.54B.
09:13 EDTABTAbbott sees accelerating sales growth in 2H14
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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.
07:49 EDTABTAbbott expects to increase global capacity to meet demand in 2014
Expects three new manufacturing facilities scheduled to come on line in China, India and the U.S. in Q2. Adult Nutrition remains on track to achieve an operating margin ratio of more than 20 percent of sales by 2015.
07:47 EDTABTAbbott completes enrollment in U.S., China, Japan in Absorb regulatory trials
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07:46 EDTABTAbbott backs FY14 adjusted EPS $2.16-$2.26, consensus $2.20
07:46 EDTABTAbbott reports Q1 adjusted EPS 41c, consensus 36c
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07:03 EDTENDPEndo International initiated with a Buy at Sterne Agee
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07:00 EDTTEVATeva initiated with a Neutral at Sterne Agee
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April 15, 2014
15:19 EDTABTNotable companies reporting before tomorrow's open
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14:14 EDTABTEarnings Preview: Abbott's established pharmaceuticals sales in focus
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12:26 EDTTEVATeva announces launch of generic Lunesta tablets in U.S.
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10:21 EDTACTMylan announces settlement agreement for first-to-file Generess
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09:23 EDTCOVBarclays medical supplies/devices analysts hold analyst/industry conference call
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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 14, 2014
09:05 EDTABTAbbott announces FDA clearance for test to diagnose diabetes
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08:05 EDTCOVCovidien announces FDA 510(k) clearance for Kangaroo feeding tube
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April 11, 2014
11:42 EDTCOVCovidien liability from recall appears limited, says Brean Capital
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10:30 EDTACTActavis and Mylan shares recommended at Bernstein
08:10 EDTCOVCovidien implements voluntary recall of devices
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April 10, 2014
08:34 EDTABTAbbott completes enrollment of Absorb clinical trials in U.S., Japan and China
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April 9, 2014
11:43 EDTABTGilead defended by analysts after recent pullback
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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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