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News Breaks
December 4, 2012
07:16 EDTTHLD, AMGN, GSKSome drugmakers focus on childhood cancer treatments, Bloomberg reports
Four experimental cancer treatments that may one day help gravely ill children are facing review by U.S. pediatric advisers. The medicines from GlaxoSmithKline (GSK), Amgen (AMGN) Threshold (THLD) and Boehringer Ingelheim have the potential to treat children with a variety of tumors and fast-spreading leukemia, reports Bloomberg.Reference Link
News For GSK;AMGN;THLD From The Last 14 Days
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January 23, 2015
08:52 EDTGSKArray BioPharma to hold a conference call
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08:10 EDTGSKArray agrees to acquire rights to encorafenib
Array BioPharma (ARRY) announced that it has reached a definitive agreement with Novartis (NVS) to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in Phase 3 development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline (GSK) on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals. Array previously announced a definitive agreement with Novartis to regain global rights to the Phase 3 MEK inhibitor binimetinib, the material terms of which remain in place following this agreement. In order to address competition concerns raised by the European Commission, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. The European Commission is expected to issue a decision regarding the Novartis-GSK transaction on January 28, 2015. Upon satisfaction of all conditions and closing of the deal, Array will acquire global rights to encorafenib. Other than a de minimis payment due to Novartis from Array, there are no milestone payments or royalties payable under this agreement by either party. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array all patent and other intellectual property rights Novartis owns to the extent relating to encorafenib. As part of the transaction, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Novartis will conduct and fund the COLUMBUS trial through the earlier of June 30, 2016 or completion of last patient first visit. At that time, Array will assume responsibility for the trial, while Novartis will reimburse Array for out-of-pocket costs along with 50% of Array's full time equivalent costs in connection with completing the COLUMBUS trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50% of Array's FTE costs in connection with completing the trials. Novartis will supply encorafenib for clinical and commercial use for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib. The effectiveness of the agreement is subject to the receipt of regulatory approvals and to the consummation of the Novartis-GSK transaction. In addition, Array agreed to undertake to obtain certain third party consents or waivers necessary for Array to consummate the transactions under the Novartis Agreement.
07:44 EDTGSKGlaxo says now in position to deliver 'tens of thousands' of Ebola vaccine doses
Witty expects to start seeing data from trials of Ebola vaccines in next four to five months. GlaxoSmithKline CEO Andrew Witty speaking on CNBC.
06:39 EDTGSKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 21, 2015
12:30 EDTGSKGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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10:16 EDTAMGNLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 16, 2015
08:31 EDTGSKGlaxoSmithKline CEO says more IPOs like ViiV could happen, Retuers says
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January 15, 2015
16:04 EDTAMGNAmgen announces new data from Phase 2 PEAK, Phase 3 PRIME studies
Amgen announced new data from the Phase 2 PEAK and Phase 3 PRIME studies that support the first-line use of Vectibix in combination with Folfox, an oxaliplatin-based chemotherapy regimen, in patients with wild-type RAS metastatic colorectal cancer. In an exploratory analysis from the PEAK study, treatment with Vectibix compared to Avastin resulted in a "significantly higher proportion" of patients with earlier tumor shrinkage at week eight, 64% vs. 45%, respectively, and among responding patients, a longer duration of response, 11.4 vs. 8.5 months, respectively, and greater depth of response . Overall response rates appeared to be similar between Vectibix and Avastin. This is consistent with observed overall survival and progression-free survival (PFS) rates, and with data previously reported, Amgen said. It added, "While the primary analysis from PEAK showed similar ORR between the Vectibix- and bevacizumab-based regimens, this exploratory analysis demonstrates that Vectibix produces early, sustained anti-tumor activity, which may in part explain the OS and PFS benefits seen with Vectibix versus bevacizumab in this trial."
14:31 EDTGSKMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
08:36 EDTGSKOncoMed enrolls first biomarker-selected patient in Notch1 antibody Phase trial
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07:59 EDTAMGNAmerican Society of Clinical Oncology to hold a symposium
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January 13, 2015
12:55 EDTAMGNAmgen repeats FY15 adjusted EPS view $9.05-$9.40, consensus $9.29
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12:40 EDTAMGNAmgen off highs after Express Scripts CEO talks PCSK9 costs
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07:42 EDTAMGNJPMorgan to hold a conference
33rd Annual Healthcare Conference is being held in San Francisco on January 12-15 with webcasted company presentations to begin on January 13 at 10:30 am; not all company presentations may be webcasted. Webcast Link
January 12, 2015
16:10 EDTAMGNAmgen, MD Anderson announce agreement to develop BiTE
Amgen and The University of Texas MD Anderson Cancer Center announced a research collaborative agreement focusing on Amgen's bispecific T cell engager, or BiTE, antibody constructs, an immunotherapy that serves as a "bridge" between T cells and cancer cells. The research agreement will identify targets for this therapy in myelodysplastic syndrome, or MDS, a bone marrow disorder in which the body does not produce sufficient healthy blood cells. MDS affects primarily older adults over age 60 and can cause severe anemia, potentially leading to development of acute myelogenous leukemia, a blood cell cancer.
12:04 EDTGSKNovartis sees closing GSK transactions in 1H15
Novartis (NVS) says portfolio transformation is progressing "on track." Sees closing GlaxoSmithKline (GSK) transactions in 1H. In 2015, plans to execute integration of GSK oncology business, execute separation of Vaccines, ensure successful start-up of Consumer Health JV with GSK. Sees NBS to continue to deliver synergies. Comments from slides that are being presented at the JP Morgan Healthcare Conference.
08:37 EDTGSKShire deal suggests most biotech companies in play, says JMP Securities
After Shire (SHPG) agreed to buy NPS Pharmaceuticals (NPSP), JMP Securities says the deal indicates that most biotech companies are in play, particularly those with worldwide rights to their products for well-defined patient populations. The firm expects investors to speculate all week about potential new targets in the space. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
07:17 EDTAMGNJPMorgan to hold a conference
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06:22 EDTGSKWHO approves 2 ebola vaccines to enter West Africa trials, Financial Times says
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