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News Breaks
January 7, 2014
09:34 EDTPCYC, JNJPharmacyclics says Phase III ibrutinib study meets primary endpoint
Pharmacyclics announced that an Independent Data Monitoring Committee unanimously recommended that the Phase III RESONATE study, PCYC-1112-CA, a head-to-head comparison of IMBRUVICATM, ibrutinib, versus ofatumumab, be stopped early because the primary and a key secondary endpoint of the study have been met. At the planned interim analysis, the Phase III RESONATE study demonstrated that IMBRUVICA showed a statistically significant improvement in progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Further, IMBRUVICA showed statistically significant improvement in overall survival, a key secondary endpoint of the trial. The safety profile of IMBRUVICA was acceptable and consistent with prior clinical experience. The IDMC recommended that the sponsor provide access to IMBRUVICA for subjects on the ofatumumab arm. Pharmacyclics has informed the U.S. Food and Drug Administration of the recommendations of the IDMC. Similarily, Janssen (JNJ), the co-developer of IMBRUVICA, has informed the European Medicines Agency. Both companies are engaging in a dialogue with the Health Authorities to define the next regulatory steps and anticipate providing a comprehensive RESONATE study report to them within the coming months. The company anticipates that the detailed data analysis from this RESONATE Phase III study will be presented at an upcoming oncology conference.
News For PCYC;JNJ From The Last 14 Days
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May 26, 2015
08:32 EDTPCYCAbbVie completes acquisition of Pharmacyclics
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08:14 EDTJNJBoston Biotech Conferences to hold a conference
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May 22, 2015
10:52 EDTJNJJPMorgan says Actavis shares cheap compared to peers
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08:17 EDTJNJJohnson & Johnson reports STELARA receives CHMP positive opinion
Janssen-Cilag announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency adopted a positive opinion recommending approval for the use of STELARA for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
08:06 EDTPCYCPharmacyclics announces positive opinion from EMA for Imbruvica
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08:00 EDTPCYCAbbVie announces expiration of HSR waiting period for Pharmacyclics acquisition
AbbVie (ABBV) announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for AbbVie's purchase of Pharmacyclics (PCYC) has expired today. The expiration satisfies the exchange offer condition with respect to the approvals and clearances required under antitrust laws. Assuming that the other customary exchange offer conditions are satisfied, including a minimum tender of at least a majority of outstanding Pharmacyclics shares, it is expected that the exchange offer to acquire all of the outstanding shares of common stock of Pharmacyclics will expire today at 5:00 p.m., New York City time, without any further extension.
May 21, 2015
17:08 EDTJNJJohnson & Johnson Chief Accounting Officer Stephen Cosgrove to retire in October
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08:04 EDTPCYCAbbVie announces offer consideration for acquisition of Pharmacyclics
AbbVie (ABBV) announced the per share offer consideration amounts pursuant to its previously announced offer to acquire each outstanding share of common stock of Pharmacyclics (PCYC) for a mix of cash and AbbVie common stock, as described in the Registration Statement on Form S-4 filed with the SEC by AbbVie on March 23, 2015, as amended. The mixed consideration will consist of $152.25 in cash and 1.6639 shares of AbbVie common stock and, subject to proration, the all-stock consideration will consist of 3.9879 shares of AbbVie common stock.
May 20, 2015
16:26 EDTJNJOn The Fly: Top stock stories for Wednesday
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10:26 EDTJNJJanssen acquires licence from Novo Nordisk for autoimmune disease development
Novo Nordisk (NVO) announced it has signed an agreement with Janssen Biotech (JNJ) under which Janssen will acquire an exclusive global license to further develop and commercialize a clinical program focused on therapy within autoimmune diseases. The program targets modulation of certain immune cells via a cell surface receptor, specifically the NKG2D receptor. Terms of the agreement have not been disclosed.
09:07 EDTJNJ, PCYCJohnson & Johnson says exploring eight new indications for Imbruvica
Imbruvica is jointly developed and commercialized by Pharmacyclics (PCYC) and Johnson & Johnson (JNJ) subsidiary Janssen Biotech. AbbVie (ABBV) is in the process of acquiring Pharmacyclics.
08:49 EDTJNJJohnson & Johnson: Priorities for free cash flow include dividends, repurchases
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08:30 EDTJNJAchillion price target lowered to $16 from $25 at Leerink
Leerink says Achillion's deal with Johnson & Johnson (JNJ) increases the probability that it will be a competitive commercial-stage player in hepatitis C. The firm believes the collaboration limits share downside as well as upside by making the "home-run scenario of great combo data leading to an acquisition less likely." It lowered its price target for Achillion shares to $16 and keeps an Outperform rating on the name.
08:15 EDTJNJJohnson & Johnson CEO Alex Gorsky says won't pursue pure-play strategy
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08:02 EDTJNJJohnson & Johnson to hold a meeting
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07:51 EDTJNJAchillion shares remain undervalued after HCV pact with J&J, says Cowen
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07:33 EDTJNJJ&J to file more than 10 new '$1B potenital' products by 2019
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07:30 EDTJNJAchillion downgraded on valuation at JMP Securities
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06:17 EDTJNJAchillion downgraded to Neutral from Buy at UBS
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May 19, 2015
16:10 EDTJNJAchillion enters into collaboration for HCV with Janssen
Achillion (ACHN) announced that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize one or more of Achillion's lead hepatitis C virus, or HCV, assets which include ACH-3102, ACH-3422, and sovaprevir. Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets. A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration. Additionally, in an equity transaction separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation JJDC, Inc. will invest $225M in Achillion and, in return, receive approximately 18.4M newly issued, unregistered shares of Achillion at a price of $12.25 per share. The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. Transitional clinical development and technology transfer activities under the collaboration are expected to take place over the next several months.
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