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Highlights from the Current IssueSummer 2010Cover Story Managing The ImmunomodulatorsDosage and indication "creep" with the new biologics to treat inflammatory diseases have payers enforcing strict utilization policies. Physicians counter that payers can’t dictate treatment. With even more biologics on the horizon, and drug spend spiralling upward, both sides need to seek a middle ground. The question is how? The Value of Observational Cohort Studies for Cancer DrugsRandomized controlled trials — the gold standard for clinical drug evaluation — can't always predict adverse events in real-world settings. For the new cancer therapies, observational cohort studies (OCSs) can help evaluate their effects in broader populations and provide valuable information for future clinical trials. Medical Devices: Adapting to the Comparative Effectiveness LandscapeOutcomes research for medical devices has always lagged, with good reason.
Comparative effectiveness initiatives, though, will soon spur demand for more and better data, and that means more and better outcomes research training. DepartmentsOpeners Of Risks and Dreams
Michael D. Dalzell Editorial Entry and Exit
David B. Nash, MD, MBA Personalized Medicine Surprise District Court Ruling Invalidates Myriad Genetics’ BRCA Patents, But Appeal is PendingMyriad Genetics’ BRCA patents ruling. Drug Track Clinical Trials, Research, and FDA Actions
Amy Krajacic Specialty Pharmacy Diagnostics Come of AgeAn avalanche of new molecular diagnostics is on the way. Trends With Injectable Biologic Therapies on the Rise, Payers Face Tough Reimbursement IssuesThe rise of injectable biologics poses tough reimbursement issues for payers. |
Latest Biotechnology NewsRegister here to receive weekly biotechnology email updatesFDA Recommends Dropping Low Blood Pressure Drug Midodrine Hydrochloride 08/17/10 – The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done. Lilly Halts Development of Semagacestat, Potential Treatment for Alzheimer's Disease 08/17/10 – Eli Lilly and Company will halt development of semagacestat, a gamma secretase inhibitor being studied as a potential treatment for Alzheimer's disease, because preliminary results from two ongoing long-term Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Positive Results Announced for Phase 2 Trial of NOV-002 in Stage 2 Breast Cancer Patients 07/13/10 – Novelos Therapeutics, Inc. announced positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer, conducted by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. Alberto Montero, MD, Assistant Professor of Medicine at the Miller School and medical oncologist at Sylvester, is the Principal Investigator. Phase 3 Meeting Scheduled With US FDA Following Positive Results of Bone Marrow Regeneration Trial 07/13/10 – Australian regenerative medicine company, Mesoblast Limited, announced that based on positive results from its bone marrow transplant clinical trial conducted at the University of Texas MD Anderson Cancer Center, a formal meeting has been scheduled with the United States Food and Drug Administration (FDA) to discuss a proposed Phase 3 clinical trial program. CVS Caremark, Generation Health Select 13 Drugs for PGx Alliance 06/02/10 – CVS Caremark and Generation Health announced the 13 drug therapies that will be included in the initial offering of their integrated Genetic Benefit Management service. The firms said that they are offering the industry's first Best Test Genetics Network, which coordinates pharmacogenomic testing for members of CVS Caremark's network. |
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