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Stock Market & Financial Investment News

News Breaks
April 21, 2014
07:21 EDTNVS, JNJ, BAYRY, SNY, MRK, GILD, BAX, PFE, MDT, BMYFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
News For BAX;BAYRY;BMY;GILD;JNJ;MDT;MRK;NVS;PFE;SNY From The Last 14 Days
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May 13, 2015
18:33 EDTMRKMerck to present new Keytruda data on 10 types of cancer at 2015 ASCO meeting
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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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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.
13:12 EDTMRK, GILD, BMYSen. Sanders urges VA to break patents on Gilead hepatitis C drugs
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10:40 EDTBAXBaxter to host two day investor meeting
Two day Investor meeting to be held in New York May 18-19.
07:31 EDTSNY, PFE, GILDHeart 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 12, 2015
13:13 EDTMRKExpert says Norway biosimilar case an 'outlier,' CT Financial News reports
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10:02 EDTMDTMedtronic receives FDA approval and CE Mark for Advance ST cryoballoon
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09:26 EDTNVSNovartis Animal Health issued FDA warning letter over marketing materials
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09:02 EDTBAXBaxter expects to establish BioScience business as separate business by mid-year
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09:01 EDTBAXBaxter to acquire Oncaspar product portfolio from Sigma-Tau for $900M
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07:06 EDTBAXKamada sees FY15 revenue $70M-$73M, consensus $78.69M
Kamada (KMDA) sees revenue from its Distributed Product Segment projected to be between $26 million and $28 million and revenue from its Proprietary Products Segment projected to be between $45 million and $47 million. The company notes that revenue projections for 2015 take into account an expected negative foreign exchange impact of approximately $2.0 million in relation to product sales in Israel and Russia, and presume that U.S. revenue from the agreement with Baxter (BAX) remains on track.
06:09 EDTMRKThreshold announces Merck receives FDA Fast Track designation for evofosfamide
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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.”
15:54 EDTNVSGlaxo CEO defends strategy, warns of risks of chasing higher prices, FT says
GlaxoSmithKline (GSK) CEO Andrew Witty defends the company's shift in focus from high-priced prescription drugs to higher volume, but lower priced, products, warning that chasing ever-higher prices risks undermining the industry and may create "its own tension that leads to some kind of change,” reported Financial Times, citing an interview. Witty acknowledges the company's asset swap with Novartis (NVS) opens the door to a potential break up, but argues there are benefits to keeping pharmaceuticals, vaccines and consumer goods together and there would be “no logic” in a split at this early time after the Novartis deal, the report added. Reference Link
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