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News Breaks
June 1, 2014
16:02 EDTJNJ, PCYCImbruvica 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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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.
08:01 EDTPCYCPiper predicts two large-cap biotechs could be acquired in 2015
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December 10, 2014
09:18 EDTPCYCPharmacyclics data 'impressive,' says Roth Capital
Roth Capital believes that Pharmacyclics presented important updates at the ASH conference on Imbruvica. The firm thinks the data "all point to Imbruvica's potency in hematological malignancies." It reiterates a $188 price target and Buy rating on the shares.
December 9, 2014
05:50 EDTJNJ, PCYCPharmacyclics 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 EDTJNJ, PCYCPharmacyclics 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 EDTJNJ, PCYCPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 8, 2014
13:45 EDTPCYCTG Therapeutics says TG-1101 well tolerated in Phase 2 study
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08:32 EDTPCYCTrout Group to hold events at ASH 2014
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December 7, 2014
14:54 EDTPCYC, JNJIMBRUVICA data suggests promise in multiple myeloma
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December 4, 2014
11:23 EDTJNJAppeals court reverses patent ruling in favor of J&J unit over Covidien
Ethicon Endo-Surgery, a Johnson & Johnson (JNJ) company, appealed a district court judgment regarding certain asserted patent claims of Tyco Healthcare. The appeals court affirmed-in-part, reversed-in-part, and vacated-in-part the prior judgment, because the lower courtís 102(g) findings were correct, but its 103 determination was improper, "including its decision to exclude the 102(g) prior art from the obviousness analysis," the court stated. In 2007, Tyco Healthcare changed its name to Covidien (COV). Reference Link
09:01 EDTJNJVA negotiated $594 per dose price for Gilead HCV treatment
A Veterans Health Administration official told a Senate committee yesterday that Veterans' Affairs has "moved rapidly to deploy new, more effective, less toxic HCV treatments and has been able to negotiate significant discounts for these newer therapies." The agency negotiated a price of $594 per dose for Gilead's (GILD) Hepatitis C virus drug Sofosbuvir, below the commercial price of $1,000 per dose, VHA Chief Consultant for Pharmacy Benefits Management Michael Valentino told the Senate's Committee on Veterans' Affairs. The agency also received a $413 per dose price for Johnson & Johnson's (JNJ) Simeprevir, below the commerical price of $790. The VA has approximately 174,000 veterans in care with HCV, making it the largest single HCV provider in the U.S., Valentino pointed out. He added, "Like the rest of the country, VA has treated only a portion of Veterans for HCV because treatment and cures have been difficult to achieve due to low efficacy and high toxicity of standard drug therapies." Reference Link

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