Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . December 10th, 2006
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Legal Issues - U.S. FDA seeks injunction of seafood processor
Vaginosis - U.S. FDA approves first generic metronidazole vaginal gel
Cervical Cancer - Research results from Center for Drug Evaluation and Research update understanding of cervical cancer
Allergy & Immunology - U.S. Food and Drug Administration calls for halt to manufacture of knock-off nebulizer medications
Angina - NovaDel Pharma receives U.S. Food and Drug Administration approval of NitroMist
Avian Influenza - Rising H5N1 bird flu high-virulence sequences point to heightened potential for epidemic in humans
Breast Cancer - Novacea to focus development attention, resources on oncology product candidates, Asentar and AQ4N
Business & Finance - CollaGenex Pharmaceuticals reports net loss of $10.4 million in third quarter
Business & Finance - Cortex reports third quarter operating results
Business & Finance - CryoCor reports third quarter 2006 results and provides clinical update
Business & Finance - Dendreon reports third quarter 2006 financial results
Business & Finance - KV Pharmaceutical reports preliminary revenue of $108.8 million for Q2
Business & Finance - Onyx Pharmaceuticals reports third quarter and nine-month 2006 financial results
Business Update - Bausch & Lomb receives U.S. FDA warning letter related to South Carolina facility
Business Update - Hollis-Eden provides update on negotiations for BioShield procurement contract
Business Update - Miraculins appoints Washington D.C. law firm Hogan & Hartson to consult on U.S. FDA matters
Business Update - Pharmacopeia announces third quarter 2006 financial results, milestones achieved
Business Update - St. Jude Medical gets U.S. FDA approval of new ICD software for Merlin patient care system
Cholesterol Screening - PreMD submits 510(k) application to U.S. Food & Drug Administration for Prevu(x) LT
Dermatology - QLT announces positive findings from Phase IV G6PD deficiency study for Aczone in acne
Drug Development - Low-profile optional vena cava filter receives conditional approval to begin clinical trial
Fibromyalgia - Fibromyalgia & Fatigue Centers applaud U.S. CDC's heightened efforts to address CFS
Finance - Ciphergen agrees to exchange $27.5 million of its outstanding 4.5% convertible senior notes
Finance - Neurocrine Biosciences moves ahead toward approval for indiplon as insomnia treatment
Finance - Questcor announces net product sales up in 2006 third quarter
Finance - RITA Medical Systems reports third-quarter results
Generic Drugs - U.S. FDA grants final approval for Mylan's broad spectrum antibiotic Doxycycline tablets
Influenza - Influenza most deadly for the very old, AHRQ report finds
Market Analysis - Companion diagnostics becoming integral part of design and development of targeted cancer therapies
Medical Devices - Boston Scientific gains U.S. FDA approval of NexStent carotid artery stenting system
Obesity Therapy - Scientific Intake enrolls subjects to study noninvasive monitoring device for weight loss
Pancreatic Cancer - Rexin-G, first tumor-targeted gene therapy vector, stymies chemo-resistant cancer
Pancreatic Cancer - U.S. FDA grants orphan drug status to monoclonal antibody for treating pancreatic cancer
Postoperative Ileus - U.S. FDA issues approvable letter for Entereg (alvimopan) for postoperative ileus
Prostate Cancer - Dendreon announces preliminary results from PROTECT study
Surgical Technology - U.S. FDA highlights InSightec's ExAblate 2000 non-invasive surgery technology for uterine fibroids
Thrombophilia - Instrumentation Laboratory receives U.S. FDA clearance for homocysteine assay
Cancer Vaccines - New findings from Public Health Institute in the area of cancer vaccines published
Epidemic - New findings reported from Brain Science Institute describe advances in epidemic
Epidemic - Study findings on epidemic are outlined in reports from University of Leiden
Legionnaire Disease - New legionnaire disease findings from Rega Institute for Medical Research published
Plague - Study findings on plague are outlined in reports from Institute of Microbiology and Epidemiology
Healthcare - Researchers from Yale University, U.S., release new healthcare data
Obesity - Findings from University of Ottawa, Canada, in obesity provide new insights
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