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The judge found that safe harbor protections don’t apply because the patented products in question “are not subject to FDA premarket approval.” Read More
Pfizer estimated that only about 10 million treatment courses will be delivered by the end of June with the remaining 10 million not expected to be delivered until September’s end. Read More
The FDA has announced that due to the fast-spreading Omicron variant of COVID-19, it will postpone the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022, as well as postponing nonmission-critical work. Read More
An appraisal committee for the UK’s National Institute for Health and Care Evidence (NICE) has recommended against National Health Service (NHS) use of Lynparza (olaparib), AstraZeneca’s blockbuster cancer drug, for treating men with previously treated hormone-resistant metastatic prostate cancer with BRCA1 or BRCA2 mutations. Read More
Sen. Joe Manchin (D-W.Va.) reiterated his opposition yesterday to President Biden’s nearly $2 trillion social spending package, saying there are currently no negotiations underway — further sinking the Build Back Better Act’s prospects in the Senate. Read More
The FDA has issued nasal-spray maker Amcyte Pharma of Kirkland, Wash., a warning letter for marketing an unapproved and misbranded product related to COVID-19. Read More