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Regulatory and Policy News Developments Impacting Pharma
Pink Sheet editors and special guest Michael McCaughan discuss the legacy of long-time Oncology Center of Excellence Director Richard Pazdur, who retired from the FDA in December.
Manufacturers are responding to a convergence of factors, but plans will miss the rebate dollars they have relied on in the current pricing model.
The October 2024 reorganization that moved compliance functions back into the product centers has resulted in speedier issuance of biologics warning letters and an increase in drug manufacturing facility classifications, FDA compliance officials said.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.
Europe’s RADIAL study comparing fully decentralized, hybrid and conventional trial approaches reveals why online recruitment is not simple.
The labeling recommendation that Duchenne muscular dystrophy patients should maintain proximity to an appropriate healthcare facility for at least two months following infusion will add to the treatment burden.
Pharmaceutical companies will be expected to phase out certain animal tests in the drug development process under a UK roadmap aimed at pivoting towards using alternative models, such as organ-on-a-chip systems and artificial intelligence.