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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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November 19, 2014
09:04 EDTJNJJohnson & Johnson submits NDA for three-month paliperidone palmitate
Janssen Research & Development, a Johnson & Johnson company, announced the submission of a New Drug Application, or NDA, for three-month atypical antipsychotic paliperidone palmitate to the FDA. The NDA seeks approval for the medication as a treatment for schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic that has a four times a year dosing schedule.
07:52 EDTTKPYYInforma Business Information to hold a conference
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06:30 EDTJNJJohnson & Johnson, Boston Scientific trial set to start tomorrow, Reuters says
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November 17, 2014
07:16 EDTJNJMilken Institute--Faster Cures to hold a conference
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November 14, 2014
16:21 EDTJNJOn The Fly: Closing Wrap
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14:53 EDTJNJCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
November 13, 2014
16:28 EDTJNJGeron announces global strategic collaboration with Janssen Biotech
Geron (GERN) announced that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses. Imetelstat is a modified oligonucleotide that is currently in early phase clinical development for myelofibrosis, or MF, and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome, or MDS, and acute myelogenous leukemia, or AML. Under the terms of the agreement, Geron will receive an initial payment of $35M due after the applicable waiting periods under the Hart-Scott Rodino Act and is eligible to receive additional payments up to a potential total of $900M for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. All sales will be booked by Janssen.
11:54 EDTJNJJanssen announces FDA approved sNDA for INVEGA SUSTENNA
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10:44 EDTJNJMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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November 12, 2014
17:33 EDTTKPYYSucampo files patent infringement suit against Dr. Reddy's Labs
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November 11, 2014
08:01 EDTTKPYYGE Healthcare, Takeda enter into alliance agreement for R&D in hepatic fibrosis
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November 10, 2014
07:44 EDTJNJJohnson & Johnson looks for acquisitions to help expand in China, WSJ says
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