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Stock Market & Financial Investment News

News Breaks
July 25, 2014
07:17 EDTGILD, JNJEMA recommends approval for Gilead, Janssen blood cancer drugs
The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting, recommended granting marketing authorizations for two new medicines with novel mechanisms of action for the treatment of different forms of rare cancers of the blood. Imbruvica and Zydelig are recommended for authorization in the treatment of adult patients with chronic lymphocytic leukemia who have received at least one prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy. Imbruvica, an orphan medicine, is also recommended for use in the treatment of adult patients with mantle cell lymphoma that has come back after previous treatments or is not responding to other treatments. Zydelig is also to be used for adult patients with follicular lymphoma that has not responded to two previous treatments. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorizations. Once marketing authorisations have been granted, decisions about price and reimbursement will then take place at the level of each Member State considering the potential role/use of these medicines in the context of the national health system of that country. The marketing-authorization applicant for Imbruvica is Janssen-Cilag International (JNJ) and the marketing-authorization applicant for Zydelig is Gilead Sciences (GILD).
News For GILD;JNJ From The Last 14 Days
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January 20, 2015
10:33 EDTJNJJohnson & Johnson falls post-earnings, levels to watch
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09:48 EDTJNJJohnson & Johnson says eyeing options in orthopedics, surgical, vision care
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09:38 EDTGILDActive equity options trading
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09:21 EDTJNJJ&J says negative impact of currency to be 'more significant' than expected
Says currency impact will be more significant in 1H than in 2H.
09:20 EDTJNJJ&J says 'comfortable' with models reflecting midpoint of FY EPS view
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09:18 EDTJNJJohnson & Johnson sees FY15 reported sales $75B-$76B
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09:18 EDTJNJJohnson & Johnson CEO says core businesses 'strong'
Johnson & Johnson (JNJ) providing sustainable, high quality healthcare "one of society's greatest challenges." Says core businesses "strong," positioned to continue expanding their leadership positions. CEO Alex Gorsky says company is changing the way it interacts with customers, evolving to be more "effective," "efficient." Says U.S. OTC consent decree requirements completed. Says in the process of developing a China lung center. Says still plans to take $1B out of P&L in next three years. Says aims to bring Ebola vaccine to market "as fast as possible." Says "well-positioned" for long-term. Says currency headwinds have increased "quite substantially," negatively impacting sales, earnings to greater extent than company had anticipated. Sees Depomed (DEPO) transaction closing in Q2. Expects R&D tax credit will be renewed in 2015. If R&D tax credit is approved, sees effective tax rate for 2015 of approx. 20%-21%. Sees operational sales growth for 2015 approx. 6%. Says Wall Street forecasts may not adequately reflect likely negative impact in 2015 of foreign exchange. Sees FY15 operational sales growth 1%-2% in constant currency. Comments made on the Q4 earnings conference call.
08:18 EDTJNJJohnson & Johnson sees 10 major Pharmaceuticals filings from 2013-2017
Sees 10 major filings, 25 line extensions in Pharmaceuticals expected between 2013-2017. Sees about 100 ongoing discovery projects, 50 novel compounds in early development, 5 breakthrough designations. Sees 30 major Medical Devices filings expected from 2014-2016, 20 key Consumer product launches expected global in 2015. Says near-term priorities include: Accelerating growth in Medical Devices through innovation, expanding market leadership in key consumer segments like OTC, Oral Care, Baby and Beauty. Comments from slides that will be presented on the Q4 earnings conference call.
07:52 EDTJNJJohnson & Johnson reports Q4 Pharmaceutical sales $8B
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07:48 EDTJNJJohnson & Johnson sees FY15 adjusted EPS $6.12-$6.27, consensus $6.13
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07:46 EDTJNJJohnson & Johnson reports Q4 EPS ex-items $1.27, consensus $1.26
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January 16, 2015
16:29 EDTJNJOn The Fly: Closing Wrap
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14:54 EDTGILDGilead at high of day, up 3% after reaching hep C drug pact with Aetna
14:46 EDTGILDAetna, Gilead confirm discount pricing for hepatitis C drugs Harvoni, Sovaldi
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13:05 EDTGILDGilead granted orphan status for pulmonary arterial hypertension treatment
The FDA granted Gilead orphan status for its treatment of pulmonary arterial hypertension. Reference Link
13:01 EDTJNJEarnings Preview: Johnson & Johnson reports after recent Goldman downgrade
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12:43 EDTJNJOn The Fly: Midday Wrap
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09:37 EDTGILDActive equity options trading
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08:58 EDTJNJRoth Capital says Depomed now leading pain company, ups to Buy
Roth Capital upgraded Depomed (DEPO) to Buy from Neutral saying the Nucynta transaction transforms the company into a "leading pain company now with critical mass." Roth raised its price target for shares to $25. Depomed last night announced that it acquired the U.S. rights to the Nucyntafranchise for $1.05B from Johnson & Johnson's (JNJ) Jansen unit. Depomed is trading up 9% in pre-market trading to $19.19.
08:12 EDTJNJJohnson & Johnson forms Ebola vaccine development consortia
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