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News Breaks
June 1, 2014
14:24 EDTTKPYY, JNJVelcade-based therapy 'significantly' improved progression-free survival
Millennium: The Takeda Oncology Company (TKPYY) announced results from the primary analysis of an international, randomized Phase 3 study that showed treatment with a VELCADE, bortezomib-based combination therapy demonstrated a 59% relative improvement in the study’s primary endpoint of progression-free survival among previously untreated patients with mantle cell lymphoma, MCL, compared to treatment with a standard therapy. These data were presented today at the annual meeting of the American Society of Clinical Oncology, ASCO. After a median follow up of 40 months, median overall survival, OS, a key secondary endpoint, had not been reached for patients who received the VELCADE-based therapy, while a median OS of 56.3 months was observed in patients treated with the standard regimen. Overall, among patients receiving VcR-CAP compared to R-CHOP, serious adverse events, SAEs, were reported in 38% vs. 30% of patients, and grade =3 adverse events were reported in 93% vs. 85% of patients. “The 59% relative improvement in progression-free survival, along with the trend suggesting improved OS with the VELCADE-based regimen, has the potential to represent a significant advance in the frontline treatment of mantle cell lymphoma for some patients,” said Michael Vasconcelles, MD, Global Head, Takeda Oncology Therapeutic Area Unit. “Patients with relapsed MCL have benefited from access to VELCADE therapy since 2006. We look forward to working with regulatory authorities to bring this new information to physicians and patients in the near future.” VELCADE is co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies (JNJ).
News For TKPYY;JNJ From The Last 14 Days
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July 31, 2014
10:35 EDTJNJJohnson & Johnson should get new Zytiga patent shortly, says Wells Fargo
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07:23 EDTJNJJ&J withdrawing laparoscopic power morcellators from market, AP says
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July 30, 2014
09:06 EDTTKPYYTakeda unit granted orphan status for pancreatic cancer treatment
Millennium Pharmaceuticals' treatment of pancreatic cancer was granted FDA orphan designation, according to a post to the regulator's site. Reference Link
07:50 EDTJNJSenate Judiciary Committee to hold a hearing
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July 29, 2014
08:50 EDTJNJHarris & Harris invests in Accelerator Corporation
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July 28, 2014
13:20 EDTJNJPharmacyclics granted regular approval for Imbruvica
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12:26 EDTJNJPharmacyclics off lows, turns positive after FDA expands Imbruvica indication
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12:24 EDTJNJFDA 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 EDTJNJEMA 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 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
15:10 EDTTKPYYTakeda Pharmaceutical unit granted orphan status for gastric cancer treatment
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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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