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A “streamlined” process for authorizing COVID-19 vaccines modified to address significant new coronavirus strains is in the works to enable the FDA to quickly react to significant viral mutations, said Center for Biologics Evaluation and Research (CBER) Director Peter Marks. Read More
The Biden administration has moved to delay until January 2023 the implementation of a key Trump-era policy that would effectively bar pharma companies and pharmacy benefit managers (PBMs) from negotiating prescription drug rebates. Read More
Prescription drug prices that Americans pay are 156 percent higher than the combined average in 32 other countries that are also members of the Organization for Economic Co-operation and Development (OECD), the RAND Corporation has reported in an HHS-funded study. Read More
The FDA has delayed its review of Biogen and Eisai’s highly anticipated Alzheimer’s treatment candidate aducanumab, pushing back its action date to June 7 after deciding it needs more time to review additional analyses and clinical data from the drugmakers. Read More
French vaccine company Valneva said it has begun production of its investigational COVID-19 vaccine, which is now in a phase 1/2 clinical trial in the UK. Read More
At least one major drug distributor could join the fray to ship COVID-19 vaccine shots across the country and offer some slack to McKesson, the firm currently handling distribution of Moderna’s vaccine, as a third vaccine candidate appears close to authorization. Read More
Johnson & Johnson is expected to file for Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine this week, but the much-needed shot has shown to be significantly less effective than its Pfizer/BioNTech and Moderna counterparts and looks to have problems tackling the virus’ highly contagious South African variant. Read More
The European Commission granted a conditional marketing authorization on Friday for AstraZeneca’s (AZ) COVID-19 vaccine just hours after an expert panel gave its blessing to the low-cost vaccine that can be shipped and held at normal refrigerator temperatures — as the bloc intensified efforts to secure delivery of initial doses and some EU members questioned the vaccine’s effectiveness for older individuals. Read More