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For authorized biosimilars to achieve full acceptance in the marketplace, it is crucial that they are considered to be therapeutically equivalent and interchangeable with the brand reference product.
With the first marketing authorization application for a biosimilar monoclonal antibody now under consideration at the European Medicines Agency, what are the critical issues for regulators?
In an environment where the regulatory and reimbursement authorities continue to raise the bar for new oncology therapies, how are sponsors adapting clinical trial designs?
The Multiple Myeloma Research Foundation (MMRF) has developed innovative, collaborative business models to reshape the R&D enterprise with the single-minded focus of accelerating the development of new treatments for patients to extend their lives and lead to a cure.
Affymetrix was an early mover in the DNA microarray space that came to dominate the market, overcoming criticism from its users and a slew of cutthroat competitors. How did it do it?
Collaborative competitions in which communities of researchers compete to solve challenges may facilitate more rigorous scrutiny of scientific results.
Despite being caught up in regulatory proceedings for 15 years or more, AquAdvantage salmon, the first animal genetically engineered (GE) for food purposes, continues to raise concerns. Are any of these concerns scientifically justified?
The pharmaceutical industry must devote greater resources, investment and effort to address its anemic drug pipeline in the long term, rather than focusing on its bottom line in the near term.
Action needs to be taken to prevent anti-biotech activists from co-opting environmental law to derail the planting of transgenic crops that have already received regulatory approval.
The antiquated legal standard that natural laws and products are not eligible for patent protection is ill-suited for gene and diagnostics patents. Here, I propose a new, technology-agnostic framework for determining patent eligibility that is tailored to the meet the US Constitutional objective of promoting innovation.