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News Breaks
April 23, 2014
04:55 EDTESALY, ESALY, PRXL, PRXL, WAG, WAG, COV, COV, PFE, PFE, SNY, SNY, AMGN, AMGN, CPB, CPB, JNJ, JNJ, MYL, MYL, LO, LOFood & Drug Law Institute to hold a conference
2014 FDLI Annual Conference is being held in Washington, D.C. on April 23-24.
News For ESALY;MYL;JNJ;CPB;AMGN;SNY;PFE;COV;WAG;PRXL;LO From The Last 14 Days
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May 13, 2015
19:17 EDTPFEHospira and FDA detect security vulnerabilities in infusion pumps
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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.
17:19 EDTPFEPfizer, Merck KGaA to present data at ASCO for avelumab
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17:17 EDTAMGNAmgen to present key results in solid tumor, hematologic malignancy treatments
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13:43 EDTPFEHospira shareholders approve merger with Pfizer
Hospira (HSP) announced that Hospira shareholders voted in favor of the proposal to adopt the merger agreement with Pfizer (PFE) at a special meeting of stockholders held May 13 in Denver, Colorado. On February 5, Hospira and Pfizer announced they had entered into a merger agreement under which Pfizer will acquire Hospira for $90 per share in cash for a total enterprise value of approximately $17B. The merger is subject to customary closing conditions, one of which was approval of the merger by Hospira's shareholders. Additional closing conditions to be met include obtaining regulatory approvals in several jurisdictions. Hospira and Pfizer continue to expect the merger to close in the second half of 2015.
07:31 EDTPFE, SNYHeart Rhythm Society to hold a conference
Heart Rhythm 2015 is being held in Boston on May 13-16.
07:05 EDTSNYSanofi exercises option on therapeutic program with Selecta Biosciences
Selecta Biosciences., a clinical stage biotechnology company developing a novel class of targeted antigen-specific immune therapies, today announced that, under the terms of an existing strategic global collaboration, Sanofi has exercised its option to an exclusive license to develop an immunotherapy for the treatment of celiac disease. Under the terms of the collaboration, Selecta is eligible to receive research support and several pre-clinical, clinical, regulatory and sales milestones totaling up to $300 million for this new program in celiac disease. Additionally, Selecta is also entitled to up to double digit tiered royalties as percentage of product net sales for any commercialized immunotherapy resulting from these efforts with Sanofi. November 2012, Selecta announced that they had formed a strategic global collaboration to discover highly targeted, antigen-specific immunotherapies for life threatening allergies. Under the agreement, Sanofi obtained a first exclusive license to develop an immunotherapy designed to abate acute immune responses against a life threatening food allergen and an option to develop two additional candidate immunotherapies for allergies and celiac disease. With the exercise of this option by Sanofi, Selecta and Sanofi now have two initiatives actively advancing immune tolerance treatments under the terms of the 2012 agreement. In October 2014, Selecta and JDRF announced another collaboration with Sanofi to research novel antigen-specific immune therapies for Type 1 Diabetes.
May 11, 2015
17:58 EDTJNJJ&J's Janssen gets complete response letter regarding sNDA for Invega Sustenna
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17:36 EDTPFEAthersys down 10.1% after Pfizer notified that it will terminate agreement
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17:34 EDTPFEAthersys receives notification that Pfizer will terminate agreement
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16:33 EDTPFEPfizer takes minority interest in AM-Pharma, secures option to acquire company
AM-Pharma and Pfizer announced that Pfizer has acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon completion of a Phase II trial of recAP in the treatment of Acute Kidney Injury related to sepsis. There are no drugs currently approved for this condition and the only treatment option is dialysis and supportive care. Results from the current Phase II trial for recAP are expected in the second half of 2016. Under the terms of the agreement, Pfizer has made an upfront payment of $87.5M for the minority equity interest and exclusive option, with additional potential payments of up to $512.5M upon option exercise and potential launch of any product that may result from this agreement. Other terms of the transaction were not disclosed. “Pfizer is committed to advancing the science to address the high unmet medical need in Acute Kidney Injury,” said Mikael Dolsten, M.D., Ph.D., president, Worldwide Research and Development at Pfizer. “Clinical data for recAP show the potential to uniquely address Acute Kidney Injury in the setting of sepsis, and we look forward to working with our partners at AM-Pharma as we aim to accelerate the development of recAP into a potential first-in-class treatment for patients.”
14:27 EDTMYLCowen recommends adding to both Teva and Mylan at current levels
Cowen recommends adding to both Teva (TEVA) and Mylan (MYL) at current levels. The firm continues to believe that a Mylan transaction will proceed despite some early contentious language, and all of Mylan's concerns will be resolved.
11:53 EDTMYLTeva rejected chance to acquire Perrigo a few months ago, Globes reports
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06:01 EDTMYLStocks with implied volatility movement; MYL NOK
Stocks with implied volatility movement; Mylan (MYL) 43, Nokia (NOK) 34 according to iVolatility.
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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May 8, 2015
16:44 EDTMYLMylan chairman says would consider buying Teva in the future, Reuters says
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15:26 EDTMYLMylan chairman says would consider buying Teva in the future, Reuters says
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13:46 EDTMYLTeva looks to raise $25B to support Mylan bid, Bloomberg reports
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12:38 EDTMYLTeva seeking $25B to finance bid for Mylan, Bloomberg reports
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