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Although new botanical drugs pose many challenges for both industry and the FDA, approval of the first botanical prescription drug shows they can be successfully met.
The Minimum Information for Biological and Biomedical Investigations (MIBBI) project aims to foster the coordinated development of minimum-information checklists and provide a resource for those exploring the range of extant checklists.
Vested interests are redefining, rebranding and co-opting what is 'biopharmaceutical'. This is not just a matter of semantics—the core identity of the biotech industry and its products is at stake.
The discovery of a contaminant in batches of heparin throws into stark relief the difficulties, not only for the US Food and Drug Administration, but also for international regulatory agencies, to ensure the safety and quality of active pharmaceutical ingredients.
The heparin safety crisis sends a strong signal that urgent changes in regulatory and manufacturing oversight are needed to ensure the safety of the global drug supply.
Analysis of protein-protein interaction networks is an increasingly popular means to infer biological insight, but is close enough attention being paid to data handling protocols and the degree of bias in the data?
As sequencing technology and prediction algorithms improve, HIV genotyping and coreceptor usage prediction are likely to play an increasingly important role in guiding patient prognosis and treatment selection.
Will our increasing understanding of virus-host interactions translate into a new generation of antiviral therapeutics or steer us toward an expensive journey to nowhere?
An analysis of recent returns from venture-backed biotech firms reveals that companies receiving the most financing do not necessarily deliver the best returns.
Securing material transfer agreements can be burdensome for academics and make downstream research prohibitively expensive, particularly for small startups with limited resources. Two technology-transfer professionals debate the pros and cons of such contracts.