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News Breaks
December 4, 2012
07:55 EDTAMGN, AMGN, GSK, GSK, THLD, THLDThe FDA Oncologic Drugs Advisory Committee to hold a meeting
The Pediatric Oncology Subcommittee considers and discusses issues relating to development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products are: (1) GlaxoSmithKline's Trametinib; (2) Threshold Pharmaceuticals' TH-302; (3) Boehringer Ingelheim Pharmaceuticals' volasertib (BI 6727) and (4) Amgen's blinatumomab (MT 103 in a meeting being held at FDA Silver Springs offices on December 4 at 8 am. Webcast Link
News For AMGN;GSK;THLD From The Last 14 Days
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November 26, 2014
17:16 EDTGSKGSK says Ebola candidate vaccine well-tolerated, gets immunological response
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14:38 EDTGSKNovartis to divest Habitrol nicotine patch to settle FTC charges over Glaxo jv
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10:34 EDTGSKMylan advances after called 'most likely' Pfizer takeover target
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07:48 EDTGSKMylan now most likely takeover target for Pfizer, says Jefferies
Jefferies believes Mylan (MYL), following its combination with Abbott's (ABT) Developed Markets Established Products business, is now the most likely takeover target of Pfizer (PFE). The firm thinks Pfizer management is highly motivated to either merge with, invert into or acquire a foreign company. It believes Actavis (ACT) and AstraZeneca (AZN) are off the table as potential Pfizer targets given the former's takeover of Allergan (AGN) and latter's oncology deal with Merck KGaA (MKGAY). Jefferies calls GlaxoSmithKline (GSK) the "wild card" potential takeover target for Pfizer. The firm estimates Pfizer could pay a 25% premium for Mylan and have the deal be highly accretive.
November 25, 2014
16:08 EDTAMGNAmgen, AstraZeneca report study of brodalumab met all primary endpoints
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10:00 EDTGSKOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: 3M Company (MMM) initiated with an Underperform at RBC Capital... Ametek (AME) initiated with an Outperform at RBC Capital... AstraZeneca (AZN) initiated with an Outperform at Exane BNP Paribas... Bayer (BAYRY) initiated with a Neutral at Exane BNP Paribas... Carlisle (CSL) initiated with a Sector Perform at RBC Capital... Colfax (CFX) initiated with a Sector Perform at RBC Capital... Dover (DOV) initiated with a Sector Perform at RBC Capital... Eaton (ETN) initiated with a Sector Perform at RBC Capital... Emerson (EMR) initiated with a Sector Perform at RBC Capital... Evercore Partners (EVR) initiated with an Outperform at Macquarie... Fifth Street Asset (FSAM) initiated with a Buy at MLV & Co.... Flowserve (FLS) initiated with an Underperform at RBC Capital... General Electric (GE) initiated with an Outperform at RBC Capital... GlaxoSmithKline (GSK) initiated with an Underperform at Exane BNP Paribas... Grainger (GWW) initiated with a Sector Perform at RBC Capital... Hanesbrands (HBI) initiated with a Buy at UBS... Hercules Technology (HTGC) initiated with a Neutral at Macquarie... HomeStreet (HMST) initiated with a Neutral at Macquarie... Honeywell (HON) initiated with an Outperform at RBC Capital... IDEX Corp. (IEX) initiated with an Outperform at RBC Capital... Illinois Tool Works (ITW) initiated with a Sector Perform at RBC Capital... Ingersoll-Rand (IR) initiated with a Sector Perform at RBC Capital... ManTech (MANT) initiated with a Buy at Maxim... Novartis (NVS) initiated with an Outperform at Exane BNP Paribas... Nu Skin (NUS) initiated with a Neutral at Citigroup... Oppenheimer Holdings (OPY) initiated with a Neutral at Macquarie... Pentair (PNR) initiated with an Outperform at RBC Capital... Raymond James (RJF) initiated with a Neutral at Macquarie... Roche (RHHBY) initiated with an Outperform at Exane BNP Paribas... Roper Industries (ROP) initiated with an Outperform at RBC Capital... SPX Corp. (SPW) initiated with a Sector Perform at RBC Capital... Sanofi (SNY) initiated with an Outperform at Exane BNP Paribas... Tyco (TYC) initiated with an Outperform at RBC Capital... United Technologies (UTX) initiated with an Outperform at RBC Capital... WESCO (WCC) initiated with an Outperform at RBC Capital... Xylem (XYL) initiated with a Sector Perform at RBC Capital.
05:26 EDTGSKGlaxoSmithKline initiated with an Underperform at Exane BNP Paribas
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November 24, 2014
09:15 EDTAMGNAmgen terminates all Amgen-sponsored clinical studies of rilotumumab
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07:31 EDTGSKMerck, NewLink Genetics enter into agreement for investigational Ebola vaccine
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06:32 EDTGSKGSK investors expected to vote on Novartis deal in December, Reuters reports
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November 20, 2014
08:02 EDTAMGNAmgen management to meet with UBS
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November 19, 2014
07:52 EDTGSKInforma Business Information to hold a conference
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07:09 EDTAMGNJefferies to hold a conference
2014 Global London Healthcare Conference is being held in London, England on November 19-20.
November 18, 2014
16:02 EDTAMGNAmgen presents long-term data on safety, efficacy of evolocumab
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09:23 EDTAMGNAmgen to host conference call
Management discusses Amgen's cardiovascular program, as well as the evolocumab data presented at the American Heart Association (AHA) Scientific Sessions 2014, on a conference call to be held on November 18 at 7 pm. Webcast Link
07:20 EDTGSKEuro Organization for Research & Treatment of Cancer co-hosts a symposium
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07:03 EDTAMGNAmgen management to meet with UBS
Meeting to be held in Zurich on November 18 hosted by UBS.
November 17, 2014
17:02 EDTGSKClovis in oncology clinical trial collaboration with GlaxoSmithKline
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07:05 EDTTHLDThreshold Pharmaceuticals announces TH-302, bevacizumab Phase 1/2 interim data
Threshold Pharmaceuticals announced interim data from a U.S. investigator-sponsored Phase 1/2 clinical trial of the investigational anticancer drug TH-302 in combination with bevacizumab for the treatment of glioblastoma, or GBM, the most lethal form of brain cancer. All patients in the study had previously progressed on single-agent bevacizumab, the only FDA-approved therapy for GBM patients with progressive disease following prior therapy. As reported by the investigator, in a total of 22 evaluable patients, best responses included one complete response and three partial responses for a response rate of 18%, and ten stable disease assessments for a clinical benefit rate of 64%; eight patients had progressive disease. Median progression-free survival was 2.8 months, and median overall survival was 4.6 months. In addition, the FDA, through its Office of Orphan Product Development, recently awarded Dr. Brenner a grant for a Phase 2 clinical trial of TH-302 for the treatment of GBM. His is one of 15 grants the FDA awarded in 2014 in order to boost the development of medical device, drug, and biological products for patients with rare diseases. According to the FDA, the grants are for clinical studies on safety and/or effectiveness of products that could either result in, or substantially contribute to, approval of the products.
05:32 EDTGSKMedidata announces collaboration with GlaxoSmithKline
Medidata (MDSO) announced the completion of a method development project conducted in partnership with GlaxoSmithKline (GSK) to evaluate the impact of unifying mobile health, or mHealth, devices with cloud-based technologies in a clinical trial setting. The joint initiative assessed the capabilities of mHealth tools and evaluated how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs. The collaborative project, which took place at GSK’s Human Performance Lab, demonstrated that mHealth technologies have the power to comprehensively collect large volumes of objective data that is reliable, secure and analysis-ready, and provides real-time, continuous insight into the well being of patients. All of the data collected was audited and is compliant with FDA regulations. Additionally, the effort indicated that mobile devices can support the long-term goal of lessening the burden on patients participating in studies by streamlining routine procedures, eliminating unnecessary ones and reducing visits to clinical trial sites.
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