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News Breaks
June 27, 2014
08:28 EDTJNJJanssen submits EU marketing application for Velcade for MCL
Janssen-Cilag International NV announced its submission of a type II variation to the European Medicines Agency to expand the label for VELCADE to include its use, in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously untreated Mantle Cell Lymphoma. MCL is a rare and aggressive blood cancer that usually occurs in older adults. VELCADE, in combination with other agents, is currently licensed to treat patients with Multiple Myeloma who have not yet had therapy or whose cancer has begun to progress after treatment. The submission is based on data from the landmark LYM-3002 trial. In results from this study, presented at the 50th Annual Meeting of the American Society of Clinical Oncology and the 19th Annual Congress of the European Hematology Association, significant benefits were seen when treating newly diagnosed patients with MCL using a VELCADE-based combination, compared to a widely used standard of care. Patients in the study were previously untreated for their MCL and were either ineligible, or not considered, for a bone marrow transplant. Compared to the treatment combination R-CHOPć, the VELCADE-based regimen, VR-CAP* significantly improved progression-free survival and showed improvements across a range of secondary endpoints.3 An independent review committee reported the increase in median PFS to be 59 percent, whereas the study investigators reported the increase in median PFS to be 96 percent.
News For JNJ From The Last 14 Days
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October 29, 2014
11:08 EDTJNJOptions with increasing implied volatility: ACHN CZR ARCP HSY JNJ
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10:17 EDTJNJGilead retreats after Hepatitis C drug sales miss expectations
Shares of drug maker Gilead (GILD) are falling after the company last night announced lower than expected third quarter profits and reported sales of its Hepatitis C treatment, Sovaldi, that came in below expectations. WHAT'S NEW: Gilead reported Q3 earnings per share of $1.84, versus analysts' consensus estimate of $1.92. The company's revenue came in slightly above expectations. Gilead said its Sovaldi drug had generated $2.8B of sales last quarter. On average, analysts had expected sales of the drug to come in at $2.93B. Sales of Sovaldi dropped 20% in Q3 versus Q2. However, the company said on its earnings conference call that the launch of its new Hepatitis C treatment, Harvoni, was off to a strong start. ANALYST REACTION: In a note to investors earlier today, Bernstein analyst Geoffrey Porges wrote that Gilead's Q3 revenue and EPS were reduced by one-time events. Its EPS would have easily beaten expectations if the company did not have to pay one-time taxes related to the Affordable Care Act, Porges stated. The lower than expected Sovaldi sales were caused by a variety of factors, including anticipation of the Harvoni launch, the analyst believes. The challenges facing Sovaldi should not affect Harvoni's performance in Q4 and 2015, added Porges, who remains very upbeat on the company's overall Hepatitis C franchise for the near to medium term. He kept a $130 price target and Outperform rating on the shares. Analysts at UBS also remained positive on Gilead, writing that the company had a good quarter with its HIV franchise that resulted in a top-line beat despite the lower than expected Sovaldi sales. The firm said it remains bullish on the Harvoni launch and sees potential upside to estimates. UBS reiterated its Buy rating and $125 price target on Gilead shares. OTHERS TO WATCH: Other pharmaceutical companies offering and developing Hepatitis C treatments include Johnson & Johnson (JNJ) and Abbvie (ABBV). PRICE ACTION: In early trading, Gilead fell 2% to $111.25.
October 28, 2014
13:09 EDTJNJOptions with increasing implied volatility
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07:21 EDTJNJCBI to hold a conference
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October 27, 2014
07:29 EDTJNJWorldwide Business Research to hold a conference
ProcureCon Pharma 2014 is being held in Philadelphia on October 27-29.
October 24, 2014
08:15 EDTJNJJohnson & Johnson management to meet with JPMorgan
Meetings to be held in Chicago/Kansas City on October 29 hosted by JPMorgan.
06:32 EDTJNJJohnson & Johnson found 'not liable' in all-metal hip implant suit, WSJ reports
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October 23, 2014
05:58 EDTJNJStocks with implied volatility below IV index mean; XLNX JNJ
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October 22, 2014
17:50 EDTJNJBavarian Nordic announces expanded collaboration with Janssen on MVA-BN
Bavarian Nordic A/S announced that it has agreed with Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to expand the collaboration announced earlier to include evaluation of Bavarian Nordic's proprietary vaccine platform technology, MVA-BN, for additional undisclosed disease targets. Bavarian Nordic and Janssen will collaborate on the evaluation of MVA-BN for three additional infectious disease targets. Janssen is granted the exclusive option to collaborate on one or more of the targets, following scientific evaluation of MVA-BN-based vaccine candidates, which will be developed by Bavarian Nordic.
05:31 EDTJNJJohnson & Johnson announces commitment to speed Ebola vaccine development
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October 20, 2014
12:36 EDTJNJOptions with decreasing implied volatility
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08:14 EDTJNJPharmacyclics files supplmeental NDA for Imbruvica for macroglobulinemia
Pharmacyclics (PCYC) announced that it has submitted a supplemental New Drug Application to the FDA based on data from a Phase 2 study evaluating the use of IMBRUVICA in patients with Waldenstrom's macroglobulinemia. IMBRUVICA, which received FDA Breakthrough Therapy Designation in February 2013 for patients with WM, is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ).
October 17, 2014
16:55 EDTJNJStocks end volatile week lower amid oil price plunge
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10:37 EDTJNJOptions with decreasing implied volatility: ATLS JNJ XLNX JNK HYG
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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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October 16, 2014
14:47 EDTJNJRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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