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News Breaks
June 1, 2014
14:24 EDTJNJ, TKPYYVelcade-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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December 19, 2014
11:08 EDTJNJJohnson & Johnson receives positive CHMP opinion to extend Velcade indication
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December 17, 2014
09:04 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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09:02 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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08:06 EDTJNJInovio appoints Zane Yang as VP, Clinical Development, Oncology
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December 16, 2014
07:20 EDTJNJGeron announces early HSR clearance for collaboration with Janssen
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December 12, 2014
14:01 EDTJNJGenOn Energy to receive $3M milestone payment in Janssen collaboration
Genmab announced it has reached a milestone in its DuoBody technology platform collaboration with Janssen Biotech (JNJ), triggering a $3M payment. The milestone payment is for pre-clinical progress with a DuoBody product candidate targeting cancer. Today's news will not impact Genmab's 2014 financial guidance.
December 9, 2014
05:50 EDTJNJPharmacyclics data demonstrates safety, durability response
New, 27-month IMBRUVICA median follow-up data announced by Pharmacyclics (PCYC) support the use of IMBRUVICA over longer periods of time in patients with relapsed/refractory mantle cell lymphoma, or MCL, an aggressive type of lymphoma. More than 30% of IMBRUVICA patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Nearly half of the 111 patients treated were still living at the time of the data analysis. A second Phase II trial looked at IMBRUVICA's efficacy and safety as a single-agent treatment for MCL patients who previously had received rituximab combination therapy and at least two cycles of bortezomib. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:43 EDTJNJPharmacyclics reports IMBRUVICA data shows 84% PFS rate at one year
Pharmacyclics (PCYC) announced new, longer term data in IMBRUVICA patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, including high-risk CLL patients with deletion 17p. Results from the Phase III RESONATE trial demonstrated an 84% progression-free survival, or PFS, rate in all patients with previously treated CLL or small lymphocytic lymphoma, or SLL, who received IMBRUVICA and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATE-17, or PCYC-1117, the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICA was associated with an 83% overall response rate, or ORR, at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%. These results and additional data were presented here at the 56th American Society of Hematology, or ASH, Annual Meeting, highlighting IMBRUVICA's sustained efficacy in relapsed/refractory patients who have received at least one prior therapy. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:27 EDTJNJPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 7, 2014
14:54 EDTJNJIMBRUVICA data suggests promise in multiple myeloma
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13:23 EDTTKPYYSeattle Genetics, Takeda announce four-year data from ADCETRIS trial
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12:44 EDTTKPYYSeattle Genetics, Takeda report Phase 3 AETHERA trial data from Adcetris
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12:33 EDTTKPYYTakeda formalizes 'Takeda Oncology' to meet needs of cancer patients
Takeda Pharmaceutical announced its global oncology business unit, headquartered in Cambridge, MA, will be called Takeda Oncology. The creation of Takeda Oncology will improve the company’s ability to meet the unique and urgent needs of cancer patients, their loved ones and health care providers worldwide. Takeda will sustain its long-standing entrepreneurial approach to oncology research and development while expanding its global commercial network and resources as Takeda Oncology. Takeda is retiring the Millennium: The Takeda Oncology Company brand, and replacing it with Takeda Oncology to reflect the new global oncology business unit. “Despite the progress made in the fight against cancer, serious unmet needs persist across many forms of the disease,” said Christophe Bianchi, M.D., President, Global Oncology Business Unit. “Takeda Oncology has a deep understanding of patient needs and applies scientific rigor and resources to work to meet these needs. Now, our agile business model optimally organizes us to quickly meet the diverse needs of cancer patients, health care providers and systems around the world, and bring the next generation of cancer treatments to cancer patients who need them.”

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