New technological developments that would benefit from a new breed of affinity binders include antibody-drug conjugates that link cytotoxic drugs to targeting binders, bi-specific affinity molecules that concurrently target multiple biological pathways and new affinity reagents for the evolution of in-vivo imaging. These technologies have the potential to fundamentally reshape the industry, not only offering essential healthcare cost savings, but also to provide new medicines with improved safety and efficacy for patients.
Earlier this month, the Federal Circuit affirmed a decision by a district court that the patent at issue before it had been obtained through inequitable conduct. However, contrary to prevailing standards the district court used litigation misconduct rather than malfeasance during patent prosecution to justify its decision, raising fears that lawyers involved in obtaining patents for their clients may be found liable for conduct of (other) lawyers representing their clients in litigation.
Can the pharma world better select new molecules that will have a greater than a 1:10,000 chance of progressing through development and making a successful, safe, marketed product?
There seems to be an assumption that if something is statistically significant, it is medically relevant. The corollary would imply that something determined not statistically significant is therefore not medically relevant. But is this true? And medically relevant for whom?
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