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May 2004FeaturesRegulatory Grappling With the Dilemma of Biologic Follow-onsGenerics — a misnomer in biotechnology — are coming, but the process of developing a regulatory pathway is Byzantine and fraught with uncertainty. Biologic follow-ons have subtleties unforeseen when chemical generics first gained FDA approval. Laws are changing, but not as quickly as the science. Business Managing Biologics: 4 Case StudiesIf specialty pharmacy is your ace in the hole, why worry? How four MCOs are managing biologic products. Economics Explaining the Co$t of Biotech TherapiesNobody said biopharmaceuticals would be inexpensive. This is attributable to multiple factors and the riskiness of the drug-development process. Q&A Defining the Value Proposition of Biotech TherapiesPersuading MCOs and employers to buy into the cost of biotech therapies means defining biologics’ value proposition from a payer’s viewpoint. Clinical Focus SWOT Analysis for Molecular Diagnostics: Strengths, Weaknesses, Opportunities, and ThreatsDaniel Farkas, PhD, and David Bernard, MD, PhD, discuss strengths, weaknesses, opportunities, and threats associated with molecular diagnostics. Leading Edge A Method to the mAbness?It’s the hottest area of biotech drug development, with more than 100 currently in development. If mAbs make life easier for patients with devastating diseases, demand will skyrocket. Payers want want proof of their value. DepartmentsEditor’s Memo ‘Generics’: This Fight Is Far From Over
Michael D. Dalzell Editorial You Should Have Been There
David B. Nash, MD, MBA Drugs & DiagnosticsWho can fill McClellan’s at FDA? Also, approvals and clinical trials. Discourse: StatesideStates push new laws allowing stem cell research and therapeutic cloning. Biotech BusinessIPOs feature companies with products in later stages of development. |
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