Particularly in the case of accelerated drug approvals and drugs for rare diseases (orphan drugs), the evidence available at the time of market access is often insufficient for the early benefit assessment of drugs. Often, ...
Jan 24, 2020
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Given the death, suffering, social disruption and economic devastation caused by COVID-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus.
Jun 10, 2020
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At the beginning of August, the European Medicines Agency (EMA) published a report on a pilot project of a new accelerated path for drug approval (adaptive pathways). In this approval procedure, for a highly restricted population ...
Aug 9, 2016
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Drug approvals in the United States between 2010–2019 were aligned with the US, but not global, burden of disease and the increasing number of expedited drug approvals could make the gap worse according to a study in the ...
Mar 12, 2024
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While the pipeline of new antibiotics has improved over the past six years, momentum in the development of new infection-fighting agents remains inadequate and could take a significant downturn without new incentives, a report ...
Feb 6, 2019
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Although randomised clinical trials (RCTs) remain the gold standard for evaluating the benefit/risk of cancer drugs, single-arm trials (SATs) can provide invaluable opportunities to speed up cancer drug development and approval, ...
Oct 11, 2016
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and the subsequent deaths of 15 individuals—has renewed scrutiny on the contemporary practice of pharmacy compounding. The risks to patients, and associated liability risk to prescribing physicians, largely outweigh the ...
Oct 15, 2012
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Expanding access to naloxone is a key component of the national strategy to end the opioid crisis in America, and community pharmacies play a central role in distributing this overdose-reversing medication.
Aug 29, 2024
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