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News Breaks
March 17, 2014
10:46 EDTRHHBY, REGN, SNY, TEVA, GSK, AZNLeerink's biopharma analysts hold an analyst/industry conference call
Analysts, along with two MEDACorp key opinion leaders (KOL) discuss opportunities for respiratory biologics for the treatment of severe asthma, with an emphasis on antibodies to IL-5 (AZN/GSK/TEVA) IL-4 (SNY/REGN) and IL-13 (AZN/RHHBY) on an Analyst/Industry conference call to be held on March 17 at 11 am.
News For AZN;GSK;TEVA;SNY;REGN;RHHBY From The Last 14 Days
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November 17, 2014
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.
05:30 EDTRHHBYInovio, Roche terminate collaboration for INO-5150
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November 16, 2014
14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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13:36 EDTAZNAstraZeneca presents data from studies of lesinurad combined with allopurinol
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12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
November 14, 2014
14:53 EDTSNY, AZN, GSK, RHHBYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies 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). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
13:27 EDTRHHBYRoche reports FDA nod for Avastin in platinum-resistant recurrent ovarian cancer
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07:14 EDTGSK, AZNAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
November 13, 2014
12:59 EDTGSKApollo plans bid for GSK mature drugs business, Reuters reports
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07:40 EDTSNYSanofi investor meeting timing tough in light of CEO ouster, Reuters says
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07:16 EDTAZNBIT Congress to hold a conference
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07:03 EDTAZNAstraZeneca initiates development program for Brilinta reversal agent
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05:34 EDTAZNAstraZeneca, Isis Pharmaceuticals to co-develop oligonucleotide delivery methods
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November 12, 2014
11:17 EDTAZN, RHHBYLeerink major pharma & biotech analysts hold analyst/industry conference call
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09:16 EDTGSKLigand reports GlaxoSmithKline EU regulatory submission for Revolade
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08:53 EDTGSKGlaxoSmithKline weakness creates buying opportunity, says Argus
After GlaxoSmithKline cut its near-term EPS guidance, Argus still believes that the company's deals with Novartis (NVS) should boost its EPS growth in the years ahead, likely as soon as 2015. The firm thinks the stock is a good value for long-term investors, and it keeps a Buy rating on the shares.
08:18 EDTGSKUBS to hold a conference
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08:13 EDTSNY, REGNBoston Biotech to hold a conference
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07:35 EDTAZNAdvaxis submits IND application for ADXS-HPV Phase 1/2 study, MEDI4736
Advaxis (ADXS) announced that the company has submitted an Investigational New Drug application, or IND, to the FDA to conduct a Phase 1/2 study of ADXS-HPV alone or in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus, or HPV,-associated cervical cancer and HPV-associated head and neck cancer. This follows the press release issued in July announcing the clinical trial collaboration between Advaxis and MedImmune, the global biologics research and development arm of AstraZeneca (AZN).
07:22 EDTRHHBYAssociation of Molecular Pathology is holding annual meeting
2014 Annual Meeting of AMP is being held in National Harbor, Maryland on November 12-15.
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