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As the race for COVID-19 vaccines intensifies, the unprecedented problems of distributing them once they get regulatory approval are coming into focus — including the need for refrigeration throughout the supply chain. Read More
Novartis and Roche have been hit with a combined $526 million in fines by France’s competition regulator for using “abusive practices” to boost sales for an expensive age-related macular degeneration (AMD) drug by discouraging a much cheaper alternative. Read More
FDA Commissioner Stephen Hahn made clear on Thursday that he will not intervene in any decisions made by career staff on COVID-19 vaccine approvals, even though he has the authority to overrule them. Read More
The National Institutes of Health (NIH) launched two phase 3 trials yesterday, evaluating different types of blood thinners to treat COVID-19 patients. Read More
As long as a safety review of an AstraZeneca COVID-19 trial that’s been paused due to an illness allows the trial to resume, the drugmaker expects to stay on track and submit its vaccine candidate for regulatory approval by the end of the year. Read More
The FDA hit an Albuquerque, New Mexico firm with a warning letter after finding it committed drug repackaging violations and had no quality unit. Read More
Pfizer and BioNTech are nearing the finish line for a COVID-19 vaccine supply agreement with the European Commission (EC), wrapping up exploratory talks Wednesday and beginning the contract negotiation process for 200 million doses of their candidate. Read More