An analysis of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 69 new entities in the year 2023, 50 % more than in the previous year. Oncology drugs tied with congenital and infectious diseases drugs for the most approvals. Although orphan and priority approvals continued at a high pace, the rate of fast-track approvals continued to decline. The rate of industry consolidation also picked up again after decreasing slightly in 2022.
An analysis of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 69 new entities in the year 2023, 50 % more than in the previous year. Oncology drugs tied with congenital and infectious diseases drugs for the most approvals. Although orphan and priority approvals continued at a high pace, the rate of fast-track approvals continued to decline. The rate of industry consolidation also picked up again after decreasing slightly in 2022.
Last month, my co-author and I published a book on the history of drug pricing in recognition that an inability to pay for medicines is growing into a public health emergency, with the potential to be every bit as dangerous as the current pandemic. Nearly 40% of respondents claimed to have skipped medicines due to solely to cost. Public opinion in the US seems to be reaching a tipping point, where it seems likely that government intervention will be necessary to guarantee access to vital medicines.
Outside government, few industries are as important to everyday life, and yet negatively perceived, as pharmaceuticals. The Federal government and pharmaceuticals share spots at the very bottom, with 58% voicing negative sentiments according to Gallup. Such opinions are all the more remarkable given the vaccines and therapeutics, which saved countless lives and allowed the world to emerge from COVID-19.
Technology Networks. 30 Sept. 2023. Is It Finally Time to Discuss Vaccine Mandates? As a regional outbreak evolved into a global pandemic, I was one of many enlisted by the media to convey the objective realities of a deadly pandemic. Consistently cautioning against false hopes for a “Hollywood ending,” my mantra was that nature tends to be rather more complex than a two-hour feature film.
As we reach a point in the global pandemic where approximately 25% of Americans have received at least one dose of a COVID-19 vaccine, I have heard discussions relating to a football game. These comments indicate that the first quarter of the contest has been completed, with the home team doing better than anticipated, but still trailing behind a powerful foe...
Biopharmaceutical development is vital and under-appreciated. Though the popularity of the biopharmaceutical sector surged briefly as the industry delivered life-saving vaccines and therapeutics in 2020, its popularity has more recently reverted to the mean, returning it to its place below the tobacco industry. This popularity, or lack thereof, is crucial given challenges facing the industry, the nation, and the planet.
• The forty-four approvals by FDA in 2022 fell below recent rates but is within the long-term average. • Approvals for orphan indications captured more than half of all approvals. • Industry consolidation and turnover continued at a slightly lower rate.