Brenda Sandburg

Latest From Brenda Sandburg
At Solicitor General’s Urging, Supreme Court May Take Up Patent Eligibility Dispute Riling Biopharma
Federal Circuit’s rulings on subject matter patent eligibility have fractured the court, the US government says in advising the high court to review American Axle v. Neapco to provide clarity. BIO, former PTO director Kappos and Sen. Tillis also urge Supreme Court to hear the case.
Ukraine War Could Spur Changes In The Clinical Trial Paradigm
Decentralized trials are way to help displaced Ukrainians remain in studies and could encourage greater participation from individuals in other countries, those overseeing sites in Ukraine say.
Seeking To Provide ‘The Best Clarity Possible,’ ACIP Votes For COVID Vaccine Booster In Children 5-11
CDC advisory committee recommends Pfizer/BioNTech vaccine booster, but one member votes ‘no,’ citing concern that only 29% of children ages 5 to 11 have received the primary two-dose series and arguing the focus should be on additional vaccinations, not additional doses.
US FDA Could Require Pediatric Cancer Drug Combo Studies Under Amended User Fee Bill
House Energy & Commerce Committee adds Give Kids a Chance Act to user fee reauthorization package during markup. Bill was modified to exclude provision giving the FDA authority to require preclinical studies.
FTC’s New Commissioner, Alvaro Bedoya, May Bolster Tougher Stance On Pharma Oversight
Democrats gain majority on Federal Trade Commission with Bedoya’s swearing in. His positions on technology and digital privacy suggest he will align with commissioners who have advocated stricter review of pharma mergers.
Accelerated Approval, Clinical Trial Diversity Provisions Left Out Of Senate User Fee Bill
Two of the most prominent features of the House package are not addressed in the Senate measure, which predominantly focuses on cosmetics, dietary supplements and laboratory developed tests. The absence of competing proposals suggests a smooth conference process.