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Stock Market & Financial Investment News

News Breaks
July 25, 2014
07:17 EDTGILD, JNJEMA recommends approval for Gilead, Janssen blood cancer drugs
The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting, recommended granting marketing authorizations for two new medicines with novel mechanisms of action for the treatment of different forms of rare cancers of the blood. Imbruvica and Zydelig are recommended for authorization in the treatment of adult patients with chronic lymphocytic leukemia who have received at least one prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy. Imbruvica, an orphan medicine, is also recommended for use in the treatment of adult patients with mantle cell lymphoma that has come back after previous treatments or is not responding to other treatments. Zydelig is also to be used for adult patients with follicular lymphoma that has not responded to two previous treatments. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorizations. Once marketing authorisations have been granted, decisions about price and reimbursement will then take place at the level of each Member State considering the potential role/use of these medicines in the context of the national health system of that country. The marketing-authorization applicant for Imbruvica is Janssen-Cilag International (JNJ) and the marketing-authorization applicant for Zydelig is Gilead Sciences (GILD).
News For GILD;JNJ From The Last 14 Days
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May 20, 2015
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.
10:09 EDTGILDGilead CFO says 'really excited' about options to grow beyond 2018
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07:56 EDTGILDGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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07:28 EDTGILDUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 19 at 8 am; not all company presentations may be webcasted. Webcast Link
May 18, 2015
19:43 EDTGILDAnthem Blue Cross sued for limiting Harvoni usage, LA Times says
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16:16 EDTGILDGilead confirms plans to present tomorrow at UBS conference, Feuerstein reports
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14:42 EDTGILDAchillion rises as conference cancellation adds fuel to M&A speculation
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09:36 EDTGILDActive equity options trading on open
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May 15, 2015
16:01 EDTGILDOptions Update; May 15, 2015
iPath S&P 500 VIX Short-Term Futures down 20c to 20.06 Option volume leaders: AAPL BAC FB NFLX TWTR BABA CSCO TSLA MU GILD T MSFT AMZN MCD
11:08 EDTGILDOmega Advisors gives quarterly update on stakes
NEW STAKES: Targa Resources (TRGP), Targa Resources Partners (NGLS), Humana (HUM), Dow Chemical (DOW), and Twenty-First Century Fox (FOXA). INCREASED STAKES: Kinder Morgan (KMI), Chimera Investment Corporation (CIM), AerCap Holdings (AER), Shire (SHPG), and KKR & Co. (KKR). DECREASED STAKES: eBay (EBAY), Altisource Portfolio Solutions (ASPS), Caesars Entertainment (CZR), Navient (NAVI), and TerraForm Power (TERP). LIQUIDATED STAKES: HCA Holdings (HCA), Gilead (GILD), Cabot Oil & Gas (COG), and Apple (AAPL).
09:31 EDTGILDAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
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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