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Clinical Trials News |
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Clinical Trials / Drug Trials News From Medical News Today
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Latest Clinical Trials / Drug Trials News From Medical News Today.
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Merck KGaA: CHMP Opinion For Erbitux In Advanced Non-Small Cell Lung Cancer
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has adopted a negative opinion for the use of Erbitux® (cetuximab) in combination with platinum-based chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, advanced or metastatic non-small cell lung cancer (NSCLC).
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Novartis Influenza A(H1N1) 2009 Vaccine US Interim Data Show Lower Doses Of Antigen May Suffice To Generate A Protective Immune Response
Novartis announced new interim data from ongoing clinical trials demonstrating that a single 7.5µg dose of the company's influenza A(H1N1) 2009 unadjuvanted vaccine, half of the currently-approved US dose, fulfilled immune response criteria associated with protection in adults and the elderly (>=65 years of age). The data also showed a single 3.
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Sanofi-aventis And Medicines For Malaria Venture To Launch The Largest Ever Study Of An Antimalarial Drug
Sanofi-aventis ( EURONEXT: SAN and NYSE: SNY) and Medicines for Malaria Venture (MMV) announced that they have entered an agreement to launch the largest safety and efficacy study of an antimalarial drug. This field-monitoring program on ASAQ, a fixed-dose combination of artesunate and amodiaquine, started in Côte d'Ivoire in October 2009. MMV is a not-for-profit drug research and development organization dedicated to reducing the burden of malaria.
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European Medical Advisory Committee Does Not Recommend Approval Of Avastin For Deadly Form Of Brain Cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the Committee for Medicinal Products for Human Use (CHMP), which is responsible for conducting the initial assessment of medicinal products that have been filed for marketing authorisation in Europe, has issued a negative opinion relating to the a
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AstraZeneca Submits US New Drug Application For Brilinta (Ticagrelor), An Investigational Antiplatelet Agent
AstraZeneca announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA.
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Geron Presents Interim Clinical Data On Its Telomerase Inhibitor Drug At AACR-NCI-EORTC
Geron Corporation (Nasdaq:GERN) announced the presentation of interim data from its ongoing trial of imetelstat (GRN163L), a telomerase inhibitor drug, in patients with refractory, advanced solid cancers at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.
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Stem Cell Therapeutics Corp. Announces Positive Review By Data Safety And Monitoring Board For The Phase IIb Stroke Trial
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:SSS) announced today it has been advised by the Data Safety Monitoring Board ("DSMB") that a regularly scheduled safety analysis has been completed and the DSMB has recommended the Phase IIb stroke trial to continue as per the protocol. The DSMB is a group of independent clinical experts that review the ongoing conduct of a clinical trial to ensure continuing patient safety.
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Circassia Announces Successful Results From Phase II Clinical Study Of ToleroMune(R) Cat Allergy Therapy
Circassia Ltd, a specialty biopharmaceutical company focused on allergy, announced positive results from a recently completed phase II clinical study of its ToleroMune(R) cat allergy therapy, which successfully identified the optimal dosing regimens to progress into late-stage development.
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Merck Receives CHMP Positive Opinion For New Fertility Treatment, ELONVA(R)
Merck & Co., Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA® (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.
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Dendreon Receives FDA Acknowledgement Of Complete Response
Dendreon Corporation (Nasdaq: DNDN) announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA.
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