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News Breaks
January 24, 2014
05:48 EDTJNJ, AZN, SNY, PFE, GSK, LLY, NVS, RHHBYDrug firms again focus on R&D for antibiotics, WSJ reports
Over the past 15 years, drug companies left antibiotic development due to high R&D costs, poor returns and growing regulations. Now, they're finding that it's again important to search for new antibiotics as so-called superbugs increase, reports the Wall Street Journal.Reference Link
News For RHHBY;GSK;AZN;NVS;PFE;JNJ;LLY;SNY From The Last 14 Days
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May 14, 2015
09:41 EDTJNJLeerink medical devices analyst holds a cardiology luncheon meeting
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09:22 EDTRHHBY, LLY, AZNLeerink pharma/biotech analysts hold an analyst/industry conference call
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08:39 EDTPFETargacept, Catalyst Biosciences amend definitive merger agreement
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08:08 EDTPFEPfizer director Marc Tessier-Lavigne to step down from board
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07:44 EDTLLYInternational Headache Society to hold a conference
17th Congress of the International Headache Society is being held in Valencia, Spain on May 14-17.
06:04 EDTLLYEli Lilly, Sanford-Burnham to investigate immunological therapies
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05:52 EDTAZNMizuho expects CAR T stocks to be volatile after ASCO abstract
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May 13, 2015
19:17 EDTPFEHospira and FDA detect security vulnerabilities in infusion pumps
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18:12 EDTRHHBYGenentech alectinib shrank tumors in about half of ALK-positive NSCLC patients
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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.
17:24 EDTAZNAstraZeneca to update progress with immuno-oncology pipeline at ASCO
AstraZeneca and MedImmune, the company’s global biologics research and development arm, will demonstrate rapid progress with their combination-focused oncology pipeline at the American Society of Clinical Oncology, or ASCO, Annual Meeting, May 29-June 2. 61 scientific abstracts will be presented at the meeting, reinforcing the significant progress in immuno-oncology through combination therapies and innovative companion diagnostics.
17:19 EDTPFEPfizer, Merck KGaA to present data at ASCO for avelumab
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17:04 EDTRHHBYGenentech announces interim results from POPLAR study
Genentech, a member of the Roche Group announced interim results from a global, randomized Phase II study, POPLAR, in people with previously treated non-small cell lung cancer, NSCLC. The study showed the investigational cancer immunotherapy MPDL3280A doubled the likelihood of survival; hazard ratio [HR]=0.47) in people whose cancer expressed the highest levels of PD-L1 compared with docetaxel chemotherapy. An improvement in survival was also observed in people who had medium and high or any level of PD-L1 expression, as characterized by a test being developed by Roche. MPDL3280A was generally well tolerated and adverse events were consistent with what has been previously reported for MPDL3280A in NSCLC. Updated results will be presented in an oral session at the 51st Annual Meeting of the American Society of Clinical Oncology. “In our study of MPDL3280A in previously treated lung cancer, the amount of PD-L1 expressed by a person’s cancer correlated with improvement in survival,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The goal of PD-L1 as a biomarker is to identify people most likely to experience improved overall survival with MPDL3280A alone, and which people may be appropriate candidates for a combination of medicines.”
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.
11:38 EDTGSKGlaxoSmithKline downgraded to Neutral from Buy at UBS
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07:31 EDTPFE, SNYHeart Rhythm Society to hold a conference
Heart Rhythm 2015 is being held in Boston on May 13-16.
07:07 EDTGSKGSK, Emergent BioSolutions, Oxford initiate Prime Boost study of Ebola vaccine
A new phase 1 study has begun at the University of Oxford that will investigate the use of a modified vaccinia Ankara, or MVA, Ebola Zaire vaccine candidate, or MVA EBOZ, as a prime-boost to GlaxoSmithKline's (GSK) Chimp Adenovirus type 3, or ChAd3, Ebola vaccine candidate. The study, being conducted by the clinical research group of Professor Adrian Hill of the Jenner Institute, has received regulatory approval to begin from the United Kingdom's Medicines and Healthcare Products Regulatory Agency, or MHRA. The phase 1 study has a planned enrollment of 38 volunteers of which 6 will receive MVA EBOZ only while the other 32 will receive ChAd3-EBO-Z prime followed by MVA EBOZ boost. Emergent BioSolutions (EBS) manufactured the supply of MVA EBOZ to be used in this phase 1 study, which is being conducted in the U.K. with support from the Wellcome Trust and the U.K. Department for International Development.
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
09:26 EDTNVSNovartis Animal Health issued FDA warning letter over marketing materials
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06:02 EDTGSKGSK CEO cites 'poor choices' in rivals' M&A deals, Financial Times reports
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