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Latest From Drug Safety
Measles Hearings Offer Counterpoint To Pricing Spotlight: Vaccines Touted As Cost-Effective Solution To Outbreaks
Congressional hearings on the recent outbreaks of measles and other vaccine-preventable diseases offered a positive theme for the industry during the ongoing drug pricing debate.
The head of Japan’s drug and device regulator has defended and supported the country’s recent world-first decision to grant approval to a novel cell-based therapy for spinal cord injuries, saying that patient considerations came first.
Despite advisory committee pressure, US FDA stands firm against imposing REMS targeted at gout drug’s cardiovascular risks; however, Takeda must conduct utilization study to see if labeling changes impact prescribing patterns.
Regulatory harmonization is gathering pace in Latin America, which is good news for pharmaceutical companies.
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