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News Breaks
March 6, 2014
10:14 EDTJNJFDA approves label change for Doribax describing increased risk of death
The FDA announced it has concluded that Doribax, an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection, marketed in the U.S. under the name Primaxin. "Based on our analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, we have approved changes to the Doribax drug label that describe these risks," the FDA stated. The FDA said Doribax is still considered safe and effective for its FDA-approved indications - treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections. Doribax is marketed outside Japan by Johnson & Johnson.
News For JNJ From The Last 14 Days
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May 21, 2015
17:08 EDTJNJJohnson & Johnson Chief Accounting Officer Stephen Cosgrove to retire in October
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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 EDTJNJJohnson & 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.
May 15, 2015
07:35 EDTJNJMedivation price target raised to $148 from $128 at Leerink
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May 14, 2015
14:54 EDTJNJJohnson & Johnson unit reports results of VENTURE-AF trial
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09:41 EDTJNJLeerink medical devices analyst holds a cardiology luncheon meeting
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May 13, 2015
17:50 EDTJNJPharmacyclics to showcase new 'promising' Imbruvica data at ASCO
Pharmacyclics announced that ibrutinib, also known as Imbruvica, single-agent and combination data will be featured in seven oral and poster sessions at the 51st American Society of Clinical Oncology, ASCO, Annual Meeting being held May 29-June 2 in Chicago, IL. According to a statement from ASCO, Imbruvica data will also be included in the official press program during the meeting for the second time in two years. Imbruvica is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a Johnson & Johnson (JNJ) subsidiary. Data being presented include, among others, an oral presentation from the Phase III HELIOS study of ibrutinib in combination with bendamustine and rituximab in relapsed or refractory chronic lymphocytic leukemia, a poster presentation of ibrutinib in steroid-dependent or refractory chronic graft-versus-host-disease as well as a dose adherence analysis of ibrutinib 420 mg administered to previously treated CLL patients. "We look forward to sharing promising data at this year's ASCO that examines the use of Imbruvica across a broad range of hematologic disease settings from our clinical studies," said Danelle James, M.D., M.S., Head of Oncology at Pharmacyclics.
May 11, 2015
17:58 EDTJNJJ&J's Janssen gets complete response letter regarding sNDA for Invega Sustenna
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May 10, 2015
19:25 EDTJNJCourt rejects claim that drugmakers misled opiate patients, Bloomberg says
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14:05 EDTJNJJohnson & Johnson shares may deliver double-digit returns, Barron's says
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