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Stock Market & Financial Investment News

News Breaks
June 25, 2014
05:32 EDTSHPG, ACT, MYL, NVSShire says New Jersey court found Vyvanse patents infringed
Shire announces that Judge Stanley Chesler of the U.S. District Court for the District of New Jersey granted Shire's summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse were both infringed and valid. The ruling prevents the five pharmaceutical manufacturers who have filed Abbreviated New Drug Applications from launching generic versions of Vyvanse until the earlier of either a successful appeal to the U.S. Court of Appeals for the Federal Circuit, or the expiration of these patents in 2023. To appeal successfully, the ANDA Defendants must overturn the court's rulings for each of the 18 patent claims, Shire said. The court's summary judgment ruling concerning Shire's motion included 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse, which cover Vyvanse's active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD. Shire's lawsuit is against the five ANDA defendants that filed ANDAs with the FDA seeking to market generic versions of Vyvanse. The defendants are Actavis (ACT), Amneal Pharmaceuticals, Mylan (MYL), Roxane Laboratories and Novartis' (NVS) Sandoz.
News For SHPG;ACT;MYL;NVS From The Last 14 Days
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October 13, 2014
15:12 EDTACTActavis may see modest negative impact from Irish tax change, says BMO Capital
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October 10, 2014
10:20 EDTACTFidelity supports potential merger between Actavis and Allergan, Reuters reports
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07:37 EDTACTActavis more likely partner than Valeant if Allergan merges, says UBS
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05:13 EDTNVSNovartis reports new analyses of AIN457 Phase III data show consistent efficacy
Novartis announced that new analyses of AIN457 Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity. Secukinumab's new mode of action stops interleukin-17A, which plays a central role in the development of psoriasis. In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI, or Psoriasis Area and Severity Index. Skin clearance was sustained through one year of treatment. This is important as historically, psoriasis patients' disease severity at the start of treatment has been shown to negatively impact their response to other therapies. Disease severity subgroups were PASI less than or equal to 20 and PASI greater than 20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel, a standard of care anti-TNF medication.
October 9, 2014
12:28 EDTACTAllergan price target raised to $230 from $210 at BTIG
BTIG said it expected Allergan to beat the consensus forecast for Q3 EPS, but not by as much as it did, and the firm did not expect the company to raise its future EPS outlook yet again. BTIG feels the stock's move higher indicates Valeant (VRX) or Actavis (ACT) would need to bid above $200 if they hope to buy the company. BTIG maintains its Buy rating on Allergan and raised its price target on the stock to $230 from $210.
11:14 EDTACTAllergan raises outlook again as Valeant pursuit continues
Drug maker Allergan (AGN) this morning preannounced stronger than expected results and again raised its fiscal year profit guidance. The beat and raise results come after The Wall Street Journal reported on Tuesday that drug maker Valeant (VRX) and hedge fund Pershing Square intend to raise their previous bid for Allergan by $15 per share to about $191. Meanwhile, also on Tuesday, Reuters said that drug maker Actavis (ACT) plans to make a new merger offer to Allergan, and sources indicated to the news service that Allergan may be willing to consider an offer from Actavis if the bid is for more than $200 per share. WHAT'S NEW: Allergan estimated that its third quarter earnings per share would come in at $1.76-$1.78, versus analysts' consensus estimate of $1.48. The drug maker had previously provided Q3 EPS guidance of $1.44-$1.47. Allergan raised its fiscal 2014 EPS guidance to $6.20-$6.25 from $5.74-$5.80. Analysts' consensus estimate was $5.81. This is the fourth time that Allergan has raised its guidance this year. Allergan said that its markets have been strong around the world, while it is gaining market share in most categories. ANALYST REACTION: In a note to investors today, Wells Fargo analyst Larry Biegelsen wrote that, in the wake of Allergan's guidance increase, the company's price to earnings multiple could expand to 22x its estimated 2016 earnings, up from its current multiple of 19x. In addition to the raised guidance, a potential accretive acquisition by Allergan and the possibility that it will be acquired make such an increase in the multiple "quite possible," Biegelsen contended. He kept an Outperform rating on the stock. WHAT'S NOTABLE: Allergan has reportedly held advanced talks about acquiring another company in the sector, Salix (SLXP), although CNBC's David Faber on October 2 reported that the talks between the two companies about a merger had "cooled considerably." PRICE ACTION: In late morning trading, Allergan rose fractionally to $191.06 while Valeant slid 1.5% to $124.08.
08:50 EDTACTAllergan shares have further upside, says Wells Fargo
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05:22 EDTSHPGShire provides regulatory update on SHP 465
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October 8, 2014
11:05 EDTNVSLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses congestive heart failure and the prospects for LCZ696 in HF-PEF on an Analyst/Industry conference call to be held on October 9 at 3 pm.
08:42 EDTACTSalix shares should be bought on weakness, says Sterne Agee
After Reuters yesterday afternoon reported that Actavis (ACT) plans to make a new merger approach to Allergan (AGN), Sterne Agee believes that Salix's standalone value is $162. The firm expects the shares to reach that level following approval of its Xifaxan IBS-D drug after the February 2015 PDUFA date.
07:19 EDTNVSCBI to hold a conference
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06:47 EDTMYL, ACTLawmakers may push for new regulations on generic drug makers, NY Times says
After the prices of some generic drugs soared more than 1,000% over the last year, two influential members of Congress are probing the sector and threatening to look to impose new regulations on it, according to The New York Times. Generic drug makers include Teva (TEVA), Mylan (MYL), Actavis (ACT), and Lannett (LCI).Reference Link
06:23 EDTACTActavis more inclined to pursue Allergan over Salix, says Citigroup
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06:11 EDTNVSNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.
October 7, 2014
15:21 EDTACTAllergan warms to sale as Actavis plans new approach, Reuters says
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15:01 EDTACTAllergan up 1.5% following report on Actavis planned approach on merger
14:59 EDTACTActavis plans new approach to Allergan, Reuters reports
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10:56 EDTMYLOptions with increasing implied volatility
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08:39 EDTNVSImmunoGen says Novartis exercises rights to take licenses under agreement
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07:48 EDTACTSalix reinstated with a Buy at Jefferies
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