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Stock Market & Financial Investment News

News Breaks
April 21, 2014
07:21 EDTBAX, PFE, NVS, MRK, MDT, JNJ, GILD, BMY, BAYRY, SNYFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
News For BAX;BAYRY;BMY;GILD;JNJ;MDT;MRK;NVS;PFE;SNY From The Last 14 Days
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October 17, 2014
09:06 EDTSNYAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
08:57 EDTJNJPharmacyclics price target raised to $188 from $185 at Roth Capital
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08:51 EDTJNJPharmacyclics announces European approval for Imbruvica
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08:02 EDTJNJCovidien granted preliminary injunction against Ethicon's Harmonic ACE+7
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07:58 EDTMRKDeutsche Bank specialty pharma analyst holds analyst/industry conference call
Specialty Pharmaceuticals Analyst Gilbert provides of preview of The Improved Reduction of Outcomes: Vytorin Efficacy Internal Study (IMPROVE-IT) on an Analyst/Industry conference call to be held on October 17 at 10 am.
October 16, 2014
14:47 EDTJNJRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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13:31 EDTGILDGilead announces Harvoni Notice of Compliance from Health Canada
Gilead Sciences announced that Health Canada has issued a Notice of Compliance for Harvoni. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, granted marketing authorization under the tradename Sovaldi in December 2013. The efficacy of Harvoni has been established in patients with chronic hepatitis C virus genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naive patients without cirrhosis who have baseline HCV viral load below 6M IU/mL. New Drug Submission applications are pending in Australia and New Zealand.
10:01 EDTBMYOn The Fly: Analyst Upgrade Summary
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09:04 EDTBAXBaxter says spin-off of BioScience division on track for mid-2015 completion
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09:02 EDTBAXBaxter says it still has not experienced competition for cyclophosphamide
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08:42 EDTBMYBristol-Myers upgraded at BMO Capital
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08:38 EDTPFE, BAXBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:19 EDTSNYSanofi Pasteur, Immune Design enter collaboration HSV therapy
Immune Design (IMDZ) announced that it has entered into a broad collaboration for the development of a herpes simplex virus, or HSV, immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (SNY). Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including leveraging Immune Design's GLAASTM platform, with the goal to select the best potential immune therapy for patients. The two companies will develop the products jointly through Phase 2 clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
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07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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07:03 EDTBAXBaxter sees FY14 continuing ops EPS $4.86-$4.89, consensus $5.16
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07:02 EDTBAXBaxter sees Q4 continuing ops EPS $1.30-$1.33, consensus $1.41
Sees Q4 sales growth approx. 3% excluding the impact of foreign currency. Including the impact of foreign currency, the company expects reported sales to be flat to 2013 levels. Consensus is $4.39B.
07:01 EDTBAXBaxter reports Q3 adjusted EPS $1.35, consensus $1.31
Reports Q3 revenue $4.2B, consensus $4.2B.
06:17 EDTMDTJefferies says Medtronic 'needs to do' Covidien takeover
Jefferies says it "can't see how Medtronic walks" from the Covidien (COV) takeover given how compelling the merger is. The firm confirmed with Medtronic (MDT) that nothing has changed in the company's commitment to the deal since new financing terms were announced on October 3. In Jefferies view, "Medtronic needs to do this deal." It notes the spread on the acquisition widened significantly on the news that Abbvie (ABBV) is reconsidering its acquisition of Shire (SHPG).
06:16 EDTBMYBristol-Myers upgraded to Outperform from Market Perform at BMO Capital
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