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News Breaks
June 1, 2014
16:02 EDTPCYC, JNJImbruvica shows durable, long-term responses for patients with CLL
Pharmacyclics (PCYC) announced that IMBRUVICA, ibrutinib, will be featured in an oral presentation highlighting long-term responses to treatment, with up to three years of follow up in 132 patients with treatment naive or relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, CLL/SLL. The results from this study will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology, ASCO, on June 2, 2014, at 11:33 a.m. CT. This release corresponds to abstract 7014. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ)."These results suggest responses to IMBRUVICA are exceptionally durable in patients with CLL with a median observation period past 30 months," said Dr. Susan O'Brien*, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX. "IMBRUVICA is very well tolerated. We are especially encouraged to see that patients showed durable responses regardless of their treatment history."
News For PCYC;JNJ From The Last 14 Days
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July 30, 2014
07:50 EDTJNJSenate Judiciary Committee to hold a hearing
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July 29, 2014
10:00 EDTPCYCOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Albemarle (ALB) upgraded to Buy from Hold at Topeka... American Capital Agency (AGNC) upgraded to Buy from Hold at Wunderlich... Bank of Hawaii (BOH) upgraded to Buy from Neutral at DA Davidson... Columbia Sportswear (COLM) upgraded to Hold from Sell at McAdams Wright... Costco (COST) upgraded to Conviction Buy from Neutral at Goldman... Ducommun (DCO) upgraded to Buy from Neutral at DA Davidson... Family Dollar (FDO) upgraded to Neutral from Underweight at Piper Jaffray... Ferrellgas Partners LP (FGP) upgraded to Neutral from Sell at Citigroup... Higher One (ONE) upgraded to Overweight from Underweight at Piper Jaffray... Landstar System (LSTR) upgraded to Buy from Hold at BB&T... MarkWest Energy (MWE) upgraded to Buy from Hold at Wunderlich... Matador (MTDR) upgraded to Outperform from Market Perform at BMO Capital... MicroStrategy (MSTR) upgraded at JMP Securities... Pharmacyclics (PCYC) upgraded to Outperform from Market Perform at Leerink... Provident Financial (PFS) upgraded at Sterne Agee... Sally Beauty (SBH) upgraded to Buy from Neutral at Citigroup... Tyson Foods (TSN) upgraded to Buy from Hold at Miller Tabak... WPX Energy (WPX) upgraded to Accumulate from Hold at Tudor Pickering... Zions Bancorp (ZION) upgraded at Bernstein.
08:50 EDTJNJHarris & Harris invests in Accelerator Corporation
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07:46 EDTPCYCPharmacyclics upgraded to Outperform from Market Perform at Leerink
Leerink upgraded Pharmacyclics to Outperform citing increased expectations for Imbruvica in Chronic Lymphocytic Leukemia. After surveying 57 hematologists/oncologists, Leerink has an improved outlook for the drug. The firm raised its price target for shares to $142 from $102.
July 28, 2014
13:20 EDTPCYC, JNJPharmacyclics granted regular approval for Imbruvica
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12:26 EDTPCYC, JNJPharmacyclics off lows, turns positive after FDA expands Imbruvica indication
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12:24 EDTPCYC, JNJFDA expands approved use of Imbruvica for chronic lymphocytic leukemia
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica to treat patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17, which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use. The FDA is also approving new labeling to reflect that Imbruvica’s clinical benefit in treating CLL has been verified. Imbruvica’s new use is being approved more than two months ahead of the product’s prescription drug user fee goal date of Oct. 7, the date the FDA was scheduled to complete review of the drug application. Imbruvica also received accelerated approval in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Clinical studies to verify and describe Imbruvica’s clinical benefit in mantle cell lymphoma are ongoing. Imbruvica is being jointly developed and commercialized in the United States by Pharmacyclics (PCYC) and Janssen Biotech (JNJ).
06:32 EDTJNJJ&J dispute with Boston Scientific looks set to go to trial, NY Times says
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July 25, 2014
08:54 EDTJNJ, PCYCEMA issues positive opinion, recommends approval of Imbruvica
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07:17 EDTJNJEMA recommends approval for Gilead, Janssen blood cancer drugs
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July 24, 2014
09:16 EDTJNJOn The Fly: Pre-market Movers
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08:39 EDTJNJOrganovo enters 3D bio-printed tissue agreement with J&J unit
Organovo (ONVO) announced that it has entered into an agreement with Janssen Research and Development, a pharmaceutical company of Johnson & Johnson (JNJ), to evaluate the use of 3D bio-printed tissue in a drug discovery setting, outside of the company’s work in 3D liver tissue for toxicity testing. Terms were not disclosed.
08:19 EDTJNJLeerink medical devices analyst holds an analyst/industry conference call
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July 23, 2014
14:32 EDTPCYCPharmacyclics estimates raised ahead of Q2 report at Goldman
Goldman raised Pharmacyclics' Q2 Imbruvica US sales estimate to $93M from $82M, vs. consensus of $88M and 2014 to $409M from $383M based on IMS data. The firm rates shares a Buy with a $162 price target.
July 21, 2014
18:40 EDTJNJOn The Fly: After Hours Movers
UP AFTER EARNINGS: Netflix (NFLX), up marginally after reporting Q2 results... Sanmina (SANM), up 13.2% after reporting third quarter results and fourth quarter guidance above analyst estimates... Chipotle (CMG), up 10.1%... Helix (HLX), up 5.2%... Canadian National (CNI), up 1.13%... CYS Investments (CYS), up 1.7%. ALSO HIGHER: Apache (APA), up 5% after Bloomberg says JANA discloses $1B position... Johnson & Johnson (JNJ), up 1% after announcing a $5B share repurchase program... TG Therapeutics (TGTX), up 4.3% after reporting second quarter results and preliminary clinical results from TG-1101 Phase I study... DOWN AFTER EARNINGS: Rambus (RMBS), down 3.6% after reporting second quarter results... Ultra Clean (UCTT), down 4% after reporting quarterly results. ALSO LOWER: Tallgrass Energy (TEP), down 5% after filing to sell 7M common units representing limited partners.
17:03 EDTJNJJohnson & Johnson announces $5B share repurchase program
Johnson & Johnson announced that its board has approved the repurchase of up to $5B of the company's common stock. The company had approximately 2.82B shares of common stock outstanding as of June 29.
17:01 EDTJNJJohnson & Johnson announces $5B share repurchase program
July 17, 2014
14:54 EDTJNJJohnson & Johnson weakness creates buying opportunity, says Argus
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10:56 EDTJNJJohnson & Johnson reports 18% passive stake in Minerva
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